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Aetna Aetna
Clinical Policy Bulletin:
Corneal Remodeling
Number: 0023


Policy

  1. Post-Cataract Post-Transplant Corneal Surgery

    Aetna considers correction of surgically induced astigmatism with a corneal relaxing incision (including limbal relaxing incisions) or corneal wedge resection medically necessary if the member had previous penetrating keratoplasty (corneal transplant) within the past 60 months or cataract surgery within the last 36 months and both of the following criteria are met:

    1. The degree of astigmatism must be 3.00 diopters or greater; and
    2. The member must be intolerant of glasses or contact lenses.

    Note: Correction of surgically induced astigmatism with a corneal relaxing incision (including limbal relaxing incisions) or corneal wedge resection is covered when medical necessity criteria are met, even if the member's plan excludes refractive surgery.

  2. Phototherapeutic Keratectomy

    Aetna considers phototherapeutic keratectomy (PTK) medically necessary for members with any of the following corneal conditions:

    1. Corneal scars and opacities (including post-traumatic, post-infectious, post-surgical, and secondary to pathology); or
    2. Epithelial membrane dystrophy; or
    3. Irregular corneal surfaces due to Salzmann's nodular degeneration or keratoconus nodules; or
    4. Recurrent corneal erosions when more conservative measures (e.g., lubricants, hypertonic saline, patching, bandage contact lenses, gentle debridement of severely aberrant epithelium) have failed to halt the erosions; or
    5. Superficial corneal dystrophy (including granular, lattice, and Reis-Bückler's dystrophy).

    Aetna considers PTK experimental and investigational for the treatment of infectious keratitis and all other indications because it has not been shown to be safe and effective for these indications.

    Note: Phototherapeutic keratectomy (PTK) should not be confused with photorefractive keratectomy (PRK).  Although technically the same procedure, PTK is used for the correction of particular corneal diseases, whereas PRK involves use of the excimer laser for correction of refractive errors (e.g., myopia, hyperopia, astigmatism, and presbyopia) in persons with otherwise non-diseased corneas.

  3. Refractive Surgery

    Note: Aetna's standard HMO benefit plan excludes coverage of "radial keratotomy, including related procedures designed to surgically correct refractive errors".  Traditional benefit plans generally exclude coverage for services "for or related to any eye surgery mainly to correct refractive errors".  These exclusions apply to radial keratotomy (RK), astigmatic keratotomy, photorefractive keratectomy (PRK), photoastigmatic keratectomy (PARK), laser-in-situ keratomileusis (LASIK), keratomileusis, epikeratophakia, implantation of intrastromal corneal ring segments, and other refractive surgical procedures.

    For plans that do not have a specific contractual exclusion of refractive surgery, refractive surgery is considered experimental and investigational or not medically necessary, as is outlined below.

    For the U.S. Food and Drug Administration (FDA)-approved indications and indications accepted by the American Academy of Ophthalmology (AAO), refractive surgical procedures are considered not medically necessary, because spectacles or contact lenses have been shown to provide more accurate corrections of refractive errors than refractive surgery.

    1. Radial keratotomy (RK) is not considered medically necessary for treatment of myopia ranging from -2.00 to -8.00 diopters because this refractive error can be corrected satisfactorily with eyeglasses or contact lenses.  Radial keratotomy is considered investigational for treatment of myopia greater than -8.00 diopters and all other refractive errors because its effectiveness for these indications has not been established.

    2. Astigmatic keratotomy (AK) (arcuate incision, corneal wedge resection) is considered medically necessary when performed for the correction of surgically induced astigmatism following medically indicated cataract removal or corneal transplant surgery.  Astigmatic keratotomy is considered investigational for treatment of all other refractive errors because its effectiveness for these indications has not been established.

    3. Hexagonal Keratotomy (HK) is considered experimental and investigational the treatment of hyperopia, or presbyopia following radial keratotomy because its effectiveness for these indications has not been established.

    4. Laser-in-situ keratomileusis (LASIK) is considered not medically necessary for treatment of myopia between -1.0 and -15.0 diopters, with or without astigmatism up to 5.0 diopters, because this can be corrected satisfactorily with eyeglasses or contact lenses.  Laser-in-situ keratomileusis is also considered not medically necessary for treatment of hyperopia up to + 6.0 diopters with or without astigmatism up to 5 diopters.  Laser-in-situ keratomileusis is considered investigational for treatment of myopia greater than -15.0 diopters or hyperopia greater than + 6.0 diopters, for treatment of persons with astigmatism greater than 5.0 diopters, and for all other refractive errors.  This clinical policy is based on the FDA-approved indications for LASIK.

    5. Standard keratomileusis (ALK) is considered investigational for treatment of all refractive errors because its effectiveness for trestment of refractive errors has not been proven.

    6. Epikeratoplasty (or epikeratophakia) is considered medically necessary for the following indications: (i) for the treatment of childhood aphakia since contact lenses are difficult for children to use and intraocular lens implants may result in long-term complications in children; (ii) for the treatment of scarred corneas and corneas affected with endothelial dystrophy; (iii) for the treatment of adult aphakia in circumstances where secondary implantation of an intraocular lens is not feasible because reentering the eye could affect outcome (e.g., vitreous in the anterior chamber, history of uveitis, disorganized anterior chamber that cannot support an intraocular lens, significant corneal endothelial disease, or gross corneal irregularity after trauma).  This procedure is considered investigational for correction of refractive errors and for all other cases of adult aphakia. 

    7. Keratophakia is considered investigational for correction of refractive errors because its effectiveness for the treatment of refractive errors has not been proven. 

    8. Lamellar keratoplasty (non-penetrating keratoplasty) is considered medically necessary for treatment of corneal diseases, including scarring, edema, thinning, distortion, dystrophies, degenerations, and keratoconus.  It is considered investigational for pterygium and when performed solely to correct astigmatism and other refractive errors because its effectiveness for these indications has not been established.

    9. Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty) is considered medically necessary for treatment of corneal diseases, including: (i) to improve poor visual acuity caused by an opaque cornea; (ii) to remove active corneal disease, such as persistent severe bacterial, fungal, or amebic inflammation of the cornea (keratitis) after appropriate antibiotic therapy; (iii) to restore altered corneal structure or to prevent loss of the globe that has been punctured: (iv) to treat corneal diseases, including bullous keratopathy, keratoconus, corneal scar with opacity, keratitis, corneal transplant rejection, Fuch's dystrophy, corneal degeneration, other corneal dystrophies, corneal edema, and herpes simplex keratitis.  Penetrating keratoplasty is considered investigational when performed solely to correct astigmatism or other refractive errors because its effectiveness for these indications has not been established.  Tissue procurement, preservation, storage and transportation associated with medically necessary corneal transplantation are also considered medically necessary.

    10. Photorefractive keratectomy (PRK) and Photoastigmatic keratectomy (PARK or PRK-A) are considered not medically necessary for individuals with hyperopia of up to 6.0 diopters and myopia of up to -10.0 diopters, with or without astigmatism up to 4.0 diopters, because the refractive corrections achieved with PRK and PARK are less precise than that achieved by eyeglasses or contact lenses.  Photorefractive keratectomy and PARK are considered investigational for individuals with hyperopia greater than 6.0 diopters, myopia greater than -10.0 diopters, astigmatism greater than 4.0 diopters, and for all other refractive errors.  This policy is based on the FDA approved indications for PRK and PARK. 

    11. Intrastromal corneal ring segments (INTACS) (Addition Technology, Sunnyvale, CA) are considered not medically necessary for adults with mild myopia (from -1.0 to -3.0 diopters) that have less than 1 diopter of astigmatism.  Aetna considers intrastromal corneal ring segments experimental and investigational for children, for persons with moderate-to- severe myopia (greater than -3.0 diopters), for persons with more than 1 diopter of astigmatism, and for hyperopia because their effectiveness for these indications has not been established.  Intrastromal corneal ring segments are considered medically necessary for reduction or elimination of myopia or astigmatism in persons with keratoconus or pellucid marginal degeneration who are no longer able to achieve adequate vision using contact lenses or spectacles and for whom corneal transplant is the only remaining option.  Intrastromal corneal ring segments are considered experimental and investigational for other indications because their effectiveness for indications other than the ones listed above has not been established.  Note: Where indicated for keratoconus or pellucid marginal degeneration, INTACS are not excluded from coverage under plans that exclude coverage of refractive surgery.  Please check benefit plan descriptions.

    12. Conductive Keratoplasty is considered not medically necessary for the treatment of individuals who are at least 40 years of age, who have mild-to- moderate hyperopia (0.75 D to 3.25 D), who have 0.75 D or less astigmatism, and whose eyesight has changed very little over the previous 12 months (as demonstrated by a change of less than 0.50 D in refraction).  Conductive keratoplasty is considered experimental and investigational for keratoconus and all other indications because its effectiveness for these indications has not been established. 

    13. Methods of thermokeratoplasty other than conductive keratoplasty (see above), such as the superficial treatment of Gassett and Kaufman for keratoconus, holmium:YAG laser thermokeratoplasty (laser thermokeratoplasty or LTK), or the hot needle of Fyodorov, are considered experimental and investigational for treatment of refractive errors, keratoconus, and all other indications because their effectiveness for these indications has not been established. 

    14. Orthokeratology is considered investigational for correction of refractive errors and all other indications because its effectiveness for these indications has not been established. 

    15. Scleral Expansion Surgery is considered experimental and investigational for presbyopia and all other indications because its effectiveness for these indications has not been established. 

    16. Intraocular lens implants (clear lens extraction) (aphakic intra-ocular lenses (IOLs)) are considered not medically necessary for correction of presbyopia, hyperopia, and myopia because these refractive errors can be corrected satisfactorily with eyeglasses or contact lenses.  Intra-ocular lens implants are considered medically necessary for persons with aphakia (see CPB 0508 - Cataract Removal Surgery).  

    17. Implantable contact lenses (without lens extraction) (phakic IOLs) (e.g., the Artisan [model 204 and 206] phakic IOL, also known as the Verisye [e.g., VRSM5US and VRSM6US] phakic IOL, and the Collamer lens [e.g., Visian ICL]) is considered not medically necessary for severe myopia because these refractive errors can be corrected satisfactorily with eyeglasses or contact lenses.  The Artisan (model 204 and 206) phakic IOL is considered not medically necessary for: (i) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth (acd) greater than or equal to 3.2 millimeters; and, (ii) individuals with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters.  The Visian ICL is considered not medically necessary for adults 21 to 45 years of age to (i) correct myopia ranging from -3.0 diopters to less than or equal to -15.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; (ii) to reduce myopia ranging from greater than -15.0 diopters to -20.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; and (iii) with an anterior chamber depth (acd) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation.  Phakic IOLs are considered experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established.

  4. Coverage of Corneal Remodeling Surgery to Correct Refractive Errors in Plans that Explicitly Cover Refractive Surgical Procedures:

    Note: For members whose policies specifically include coverage for refractive surgery, refractive surgical procedures are covered for their FDA-approved indications and indications accepted by the AAO, without regard to medical necessity.  (The FDA-approved indications for refractive surgical procedures are listed in section III above).  Also, RK (which does not require FDA approval) is covered for indications recognized by the AAO as established -- mild to moderate myopia of -8.00 diopters or less.  (See discussion of established indications for RK in section III above).  Aetna's payment for these services does not constitute any determination by Aetna that those services are medically necessary.

  5. Keratoprosthesis (Artificial Cornea):

    The Boston Keratoprosthesis (Boston KPro) may be considered medically necessary for corneal blindness in members who meet the following medical necessity criteria:

    1. The cornea is severely opaque and vascularized, with vision less than 20/400 in the affected eye and lower than optimal vision in the opposite eye; and
    2. The member has had 2 or more prior failed penetrating keratoplasties (corneal transplants), with poor prognosis for further grafting; and
    3. The member does not have end-stage glaucoma or retinal detachment.

    Aetna considers the Boston KPro keratoprostheses experimental and investigational for all other indications because their effectiveness for indiactions other than the one listed above has not been established.

    Aetna considers the AlphaCor keratoprosthesis experimental and investigational because of insufficient evidence of its effectiveness.

  6. Endothelial Keratoplasty:

    Aetna considers endothelial keratoplasty (Descemet's stripping endothelial keratoplasty (DSEK), Descemet's stripping automated endothelial keratoplasty (DSAEK), and Descemet's membrane endothelial keratoplasty (DLEK) medically necessary for the following indications in persons with endothelial failure and otherwise healthy corneas:

    1. Bullous keratopathy;
    2. Corneal edema;
    3. Endothelial corneal dystrophy and other posterior corneal dystropies;
    4. Mechanical complications due to corneal graft or ocular lens prostheses;
    5. Rupture of Descemet's membrane.

    Aetna considers endothelial keratoplasty procedures experimental and investigational for conditions with concurrent endothelial disease and anterior corneal disease, including anterior corneal dystrophies, anterior corneal scars from trauma or prior infection, ectatic conditions of the cornea such as keratoconus, pellucid marginal degeneration and ectasia after previous laser vision correction surgery, and for all other indications (e.g., iris atrophy) because their effectiveness for these indications has not been established.

  7. Collagen Cross-Linking for Keratoconus

    Aetna considers epithelium-off photochemical collagen cross-linkage using riboflavin and ultraviolet A medically necessary for keratoconus and keratectasia. Photochemical collagen cross-linkage is considered experimental and investigational for all other indications because its effectiveness has not been established. Epithelium-on (transepithelial) collagen cross-linkage is considered experimental and investigational for keratoconus, keratectasia, and all other indications. Performance of photochemical collagen cross-llinkage in combination with other procedures (CXL-plus) (e.g., intrastromal corneal ring segments, photorefractive keratectomy (PRK) or phakic intraocular lens implantation) is considered experimental and investigational.



Background

Refractive surgical procedures are considered by Aetna to be not medically necessary, because spectacles or contact lenses have been shown to provide more accurate corrections of refractive errors than refractive surgery.  Although the efficacy of refractive surgery is improving, the accuracy and precision of the refractive corrections achieved is substantially less than that which can be achieved with spectacle correction.  In a randomized prospective study of laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) for myopia, Hersh et al (1998) reported that 29.4 % of PRK patients and 27.1 % of LASIK patients had refractive corrections within 0.5 diopters of attempted correction at six months after surgery.  In comparison, over 99 % of patients who are corrected with glasses or contact lenses achieve refractive corrections within 0.5 diopters of normal vision (Waring, 1990).

Although the safety of refractive surgical procedures is improving, these procedures are associated with significant risks of degradation of best corrected visual acuity, as well as glare, induced regular or irregular astigmatism, regression of effect, visual aberrations (including transient or permanent glare or starburst/halo effect), and decreased contrast sensitivity.  These optical complications and their incidence are discussed in a 1997 American Academy of Ophthalmology (AAO) Preferred Practice Pattern on Refractive Errors and a 1999 AAO Ophthalmic Procedures Assessment on PRK.  According to the AAO Preferred Practice Pattern on Refractive Errors, "spectacles are the simplest and safest means of correcting a refractive error".

Radial keratotomy (RK) involves the use of radial incisions in the cornea to correct mild to moderate myopia.  According to guidelines from the AAO, radial keratotomy has been shown to be effective for treatment of myopia ranging from -2.00 to -8.00 diopters.  Radial keratotomy has not been proven to be effective for treatment of myopia greater than -8.00 diopters or for other refractive errors.  The established indications for radial keratotomy were based on the 1992 AAO Ophthalmic Procedures Assessment of Radial Keratotomy for Myopia.  The AAO's position on RK was reaffirmed in the 1997 AAO Preferred Practice Pattern on Refractive Errors, which restated that RK is indicated for "[l]ow to moderate myopia".

Astigmatic keratotomy (AK) (arcuate incision, corneal wedge resection) is a refractive surgical procedure similar to RK that is used to reduce astigmatism.  Instead of radial incisions, a curvilinear pattern is used to smooth the areas of the cornea that are too steeply curved. In some instances, surgeons have combined RK with AK in patients with myopia with astigmatism.  Variations of astigmatic keratotomy include the Ruiz Procedure and the Troutman Wedge Resection.  Astigmatic keratotomy may be indicated for the correction of surgically induced astigmatism following medically indicated cataract removal or corneal transplant surgery.  Astigmatic keratotomy has not been proven for treatment of other refractive errors.  The 1997 AAO Preferred Practice Pattern on Refractive Errors states: "[T]here are few well-controlled, prospective clinical studies available on the procedure to date, performed either individually or in connection with other keratorefractive procedures".

Laser-in-situ keratomileusis (LASIK) is a type of laser surgery of the cornea to correct refractive errors, in which a slice of the patient's cornea is removed, shaped to the desired curvature with an excimer laser, and then sutured back to the remaining cornea.  Laser-in-situ keratomileusis is approved by the Food and Drug Administration (FDA) for treatment of myopia between -1.0 and -15.0 diopters, with or without astigmatism up to 5.0 diopters.  Laser-in-situ keratomileusis has also been approved by the FDA for treatment of hyperopia up to + 6.0 diopters with or without astigmatism up to 5 diopters.  Laser-in-situ keratomileusis has not been proven to be effective for treatment of myopia greater than -15.0 diopters or hyperopia greater than + 6.0 diopters, for treatment of persons with astigmatism greater than 5.0 diopters, and for other refractive errors.

Standard keratomileusis (ALK) where the cornea is shaped with a microkeratome rather than with a laser, has not been proven to be an effective treatment for refractive errors.  The 1997 AAO Preferred Practice Pattern on Refractive Errors states "In its 1995 assessment on ALK, the American Academy of Ophthalmology identified a lack of peer-reviewed literature, although there are a number of studies ongoing.  In current clinical practice, ALK is being replaced by laser in situ keratomileusis".

Epikeratoplasty (or epikeratophakia) is a refractive surgical procedure that involves placement of a pre-carved donor corneal lens on the surface of a patient's eye.  Epikeratophakia may be indicated for the treatment of childhood aphakia since contact lenses are difficult for children to use and intraocular lens implants may result in long-term complications in children.  This procedure may also be used on scarred corneas and corneas affected with endothelial dystrophy.  In addition, although secondary implantation of an intraocular lens is the favored treatment of adult aphakia, there are circumstances where reentering the eye could affect outcome (e.g., vitreous in the anterior chamber, history of uveitis, disorganized anterior chamber that cannot support an intraocular lens, significant corneal endothelial disease, or gross corneal irregularity after trauma); in these cases of adult aphakia, epikeratophakia may be considered acceptable.  This procedure is has not been proven to be effective for the correction of refractive errors and for all other cases of adult aphakia.  The 1997 AAO Preferred Practice Pattern on Refractive Errors states that "[t]he results have been widely variable, and there have been significant complications. This procedure is not recommended for correction of myopic refractive errors, except in very unusual circumstances".  This re-affirmed the 1995 AAO Ophthalmic Procedure Assessment of epikeratophakia.

Keratophakia involves implantation of a donor cornea within the corneal stroma to modify its refractive power.  Keratophakia has not been proven to be effective for correction of refractive errors.  Keratophakia was not addressed in the 1997 AAO Preferred Practice Pattern on Refractive Errors.  However, an August 1992 AAO Ophthalmic Procedure Assessment of keratophakia concluded that they found only a "handful of reports" in peer-reviewed medical journals regarding keratophakia for correction of refractive errors, and few "well controlled studies".  The AAO assessment raised questions about the safety and effectiveness of keratophakia. Since publication of the AAO's assessment, no additional clinical studies of keratophakia for refractive errors have been published, so the questions raised by that assessment remain unanswered.

Lamellar keratoplasty (non-penetrating keratoplasty) is a corneal transplant procedure in which a partial thickness of the cornea is removed and the diseased tissue is replaced with a partial-thickness donor cornea.  The donor eye is prepared by making a partial thickness trephine incision in the cornea and dissecting free the lamellar button.  This procedure may be indicated for a number of corneal diseases, including scarring, edema, thinning, distortion, dystrophies, degenerations, and keratoconus.  It is has not been proven to be effective for correction of astigmatism and other refractive errors.

Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty) is a corneal transplant procedure involving replacement of the full thickness of the cornea with donor cornea, but retaining the peripheral cornea.  As with lamellar keratoplasty, this procedure may be indicated for a number of corneal diseases.  Most PKs are performed to improve poor visual acuity caused by an opaque cornea.  Penetrating keratoplasty has also been used to remove active corneal disease, such as persistent severe bacterial, fungal, or amebic inflammation of the cornea (keratitis) after appropriate antibiotic therapy.  Penetrating keratoplasty has also been performed to restore altered corneal structure or to prevent loss of the globe that has been punctured.  The most common indications for PK are bullous keratopathy, keratoconus, corneal scar with opacity, keratitis, corneal transplant rejection, Fuch's dystrophy, corneal degeneration, other corneal dystrophies, corneal edema, and herpes simplex keratitis.  Penetrating keratoplasty has not been proven to be effective for correcting astigmatism or other refractive errors.

Photorefractive keratectomy (PRK) is a refractive surgical procedure involving the reshaping of the surface of the cornea with an excimer laser to correct mild-to-moderate myopia.  Photoastigmatic keratectomy (PARK or PRK-A) is a refractive surgical procedure to correct myopia with astigmatism.  These procedures have been approved by the FDA for treatment of hyperopia of up to 6.0 diopters and myopia of up to -10.0 diopters, with or without astigmatism up to 4.0 diopters.  Photorefractive keratectomy and PARK have not been proven effective for correction of hyperopia greater than 6.0 diopters, myopia greater than -10.0 diopters, astigmatism greater than 4.0 diopters, and other refractive errors.  A 1999 AAO Ophthalmic Procedures Assessment on PRK and PARK concluded that it "appears to be safe and effective procedure for the treatment of low to moderate degrees of myopia and astigmatism.  Results for high degrees of myopia are associated with poorer outcomes, that is, longer stabilization periods, greater need for retreatment, and increased loss of lines of BSCVA [best spectacle corrected visual acuity]".

Phototherapeutic Keratectomy (PTK) is the same surgical procedure as PRK, but is used for the treatment of corneal diseases.  PTK has been approved by the FDA to treat the following corneal conditions: (i) superficial corneal dystrophy (including granular, lattice, and Reis-Bückler's dystrophy); (ii) epithelial membrane dystrophy; (iii) irregular corneal surfaces due to Salzmann's nodular degeneration or keratoconus nodules; (iv) corneal scars and opacities (including post-traumatic, post-infectious, post-surgical, and secondary to pathology); (v) recurrent corneal erosions when more conservative measures (e.g., lubricants, hypertonic saline, patching, bandage contact lenses, gentle debridement of severely aberrant epithelium) have failed to halt the erosions.  PTK has not been proven to be effective for treatment of infectious keratitis or other diseases.  If used unilaterally PTK will induce a certain degree of anisometropia since it induces a shift in refraction to the hyperopic (farsighted) side.  This hyperopic shift might be welcomed in myopes but may be problematic for emmetropes or low myopes.

Intrastromal corneal ring segments (INTACS) (Addition Technology, Sunnyvale, CA) have been approved by the FDA for adults with mild myopia (from -1.0 to -3.0 diopters) that have less than 1 diopter of astigmatism.  Intrastromal corneal ring segments have not been proven to be effective in children, and for correction of moderate to severe myopia (greater than -3.0 diopters), for correction of refractive errors in persons with more than 1 diopter of astigmatism, and for correction of hyperopia. Intrastromal corneal ring segments have been approved by the FDA for reduction or elimination of myopia or astigmatism in persons with keratoconus who are no longer able to achieve adequate vision using contact lenses or spectacles and for whom corneal transplant is the only remaining option.  INTACS involves inserting a flexible ring beneath the surface of the cornea to elevate the edge of the cornea.  This effectively flattens the front of the eye, decreasing nearsightedness.  Different size rings are used to correct different amounts of nearsightedness.  Boxer Wachler et al (2003) reported on a retrospective study of 74 eyes of 50 persons who received INTACS implantation.  The investigators found that the mean improvement in uncorrected visual acuity in persons with keratoconus who received INTACS was four lines of uncorrected visual acuity and two lines of best corrected visual acuity.  The investigators also reported decreases in irregular astigmatism.  In a prospective study involving 10 patients with keratoconus, Colin et al (2000) reported a 70 % improvement in uncorrected visual acuity and a 50 %improvement in best corrected visual acuity.  INTACS was approved by FDA for use in keratoconus under a Humanitarian Device Exemption (HDE), as the FDA has determined that INTACS are a medical device intended to treat a condition that affects fewer than 4,000 individuals per year in the United States (FDA, 2004).  INTACS are approved for the reduction or elimination of myopia or astigmatism in persons with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplant procedure may potentially be postponed.  According to the FDA, the specific subset of keratoconic patients proposed to be treated with INTACS prescription inserts are those who: (i) have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; (ii) who are 21 years of age or older; (iii) who have clear central corneas; (iv) who have a corneal thickness of 450 microns or greater at the proposed incision site; and (v) who have corneal transplantation as the only remaining option to improve their functional vision (FDA, 2004).

According to guidance from the National Institute for Health and Clinical Excellence (2007), INTACS can also be used for pellucid marginal degeneration, a non-inflammatory, peripheral corneal thinning disorder characterized by the erosion of the peripheral band of the inferior cornea.

There is limited evidence for the use of INTACS for corneal ectasia not secondary to keratoconus.  A technology assessment concluded that the evidence for the use of INTACS for corneal ectasias other than primary keratoconus consists of case reports and small case series (MAS, 2009).

Conductive Keratoplasty involves the application of radiofrequency thermal energy to increase the curvature of the cornea and thereby reduce hyperopia.  Conductive keratoplasty using the ViewPoint CK System (Refractec Inc., Irvine, CA) has been approved by the FDA for treatment of patients who are at least 40 years of age, who have mild to moderate hyperopia (0.75 D to 3.25 D), who have 0.75 D or less astigmatism, and whose eyesight has changed very little over the previous 12 months (as demonstrated by a change of less than 0.50 D in refraction).  Conductive keratoplasty has not been proven to be effective for correction of other refractive errors.  According to the FDA, conductive keratoplasty temporarily improves distance vision in far-sighted people.  Although some patients may retain some or all of the correction achieved during surgery, for most people the amount of farsightedness correction is temporary and will decrease over time.  Vision without glasses is improved after conductive keratoplasty, but some people still need glasses or contact lenses.  Since it corrects only farsightedness, CKSM does not eliminate the need for reading glasses.  Conductive keratoplasty has not been proven to be effective as a treatment of keratoconus.

Methods of thermokeratoplasty other than conductive keratoplasty, such as the superficial treatment of Gassett and Kaufman for keratoconus, holmium:YAG laser thermokeratoplasty (laser thermokeratoplasty or LTK), or the hot needle of Fyodorov, have not been proven to be effective for the treatment of refractive errors or keratoconus.  These methods of thermokeratoplasty have been abandoned because the corneal wound healing response produced postoperative scarring and instability (Waring, 1995).

Orthokeratology involves the application of sequentially flatter hard contact lenses to flatten the cornea and thereby reduce myopic refractive error.  Orthokeratology has not been proven to be effective for the treatment of refractive errors.  The AAO Preferred Practice Pattern on Refractive Errors states that "[a]ttempts to predict which patients will respond to orthokeratology based on ocular biomechanical or biometric parameters have not been successful.  The effects of orthokeratology have been unpredictable and poorly controlled. … This approach is not recommended".

In an ophthalmic technology assessment performed for the AAO, Van Meter et al (2008) reviewed the published literature to evaluate the safety of overnight orthokeratology (OOK) for the treatment of myopia.  Repeated searches of peer-reviewed literature were conducted in PubMed and the Cochrane Central Register of Controlled Trials for 2005, 2006, and 2007.  The searches yielded 495 citations.  The panel reviewed the abstracts of these articles and selected 79 articles of possible clinical relevance for review.  Of these 79 full-text articles, 75 were determined to be relevant to the assessment objective.  No study was rated as having level I evidence.  Two pre-market applications to the FDA were rated as having level II evidence.  There were 2 studies rated as having level II evidence.  The main source of reports of adverse events associated with OOK was 38 case reports or non-comparative case series (level III evidence).  The authors concluded that the prevalence and incidence of complications associated with OOK have not been determined.  Complications, including more than 100 cases of infectious keratitis resulting from gram-positive and gram-negative bacteria and Acanthamoeba, have been described in case reports and case series representing observations in undefined populations of OOK users.  Data collection was non-standard.  Risk factors for various complications can not be determined.  Because OOK puts patients at risk for vision-threatening complications they may not encounter otherwise, sufficiently large well-designed cohort or randomized controlled studies are needed to provide a more reliable measure of the risks of treatment and to identify risk factors for complications.  These investigators also stated that OOK for slowing the progression of myopia in children also needs well-designed and properly conducted controlled trials to examine its effectiveness.  Because of variations in orthokeratology practice, a wide margin of safety should be built into OOK regimens.

Scleral Expansion Surgery has not been proven to be effective for treatment of presbyopia.  Scleral expansion surgery involves making small incisions in the eye and inserting bands to stretch the part of the sclera that lies beneath the ciliary muscles that control accommodation (NICE, 2004).  This procedure is claimed to improve accommodation.  An assessment of scleral expansion surgery by the National Institute for Clinical Excellence (2004) recommended that "this procedure should not be used".  Based on an assessment of available published evidence, the assessment concluded that "[c]urrent evidence on the safety and efficacy of scleral expansion surgery for presbyopia is very limited" and that "[a]ll studies identified were of poor quality".  The assessment explained that "[t]here is no evidence of efficacy in the majority of patients" and that "[t]here are also concerns about the potential risks of the procedure".

Glasser (2008) noted that a variety of surgical procedures has been considered for restoring accommodation to the presbyopic eye, including surgical expansion of the sclera, using femtosecond lasers to treat the lens or with so-called accommodative IOLs.  The author stated that evidence suggests that scleral expansion can not and does not restore accommodation. 

Intraocular lens implants (clear lens extraction) (aphakic intraocular lenses (IOLs)) have been approved by the FDA for correction of presbyopia, hyperopia, and myopia. Clear lens extraction is similar to cataract removal surgery in that the natural lens is removed and replaced with an intra-ocular lens.

Implantable contact lenses (without lens extraction) (phakic IOLs) (e.g., the Artisan [model 204 and 206] phakic IOL, also known as the Verisye [e.g., VRSM5US and VRSM6US] phakic IOL, and the Collamer lens [e.g., Visian ICL]).  Phakic IOLs are new devices used to correct near-sightedness.  These thin lenses are implanted permanently into the eye to help reduce the need for glasses or contact lenses.  Phakic refers to the fact that the lens is implanted into the eye without removing the eye's natural lens.  During phakic lens implantation surgery, a small incision is made in the front of the eye.  The phakic lens is inserted through the incision and placed just in front of or just behind the iris.  The Artisan (model 204 and 206) phakic IOl is indicated for: (i) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth (acd) greater than or equal to 3.2 millimeters; and, (ii) individuals with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters.  The Visian ICL is indicated for adults 21 to 45 years of age to (i) correct myopia ranging from -3.0 diopters to less than or equal to -15.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; (ii) to reduce myopia ranging from greater than -15.0 diopters to -20.0 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane; and (iii) with an anterior chamber depth (acd) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation.  Implantable contact lenses have not been proven to be effective for other indications.

Keratoprostheses have not been proven to be as effective as penetrating keratoplasty using corneal graft tissue.  Some patients cannot undergo the standard penetrating keratoplasty using donor tissue for several reasons (e.g., disease severity, severe involvement of the conjunctiva, objection to the use of donor tissue, failed past donor tissue transplants, or when measures required to prevent graft rejection are medically contraindicated).  For these individuals, penetrating keratoplasty using a keratoprosthesis has been employed as an alternative.  The Alberta Heritage Foundation for Medical Research (AHFMR, 2001) noted that there is inadequate evidence to prove the safety and effectiveness of any keratoprosthesis model, and as keratoprosthesis models keep evolving, these new versions have not yet been proven in human trials with sufficient follow-up and patient numbers.  The AHFMR further stated that "currently there is no consensus in the literature on optimal device and implantation techniques, and no accepted standard for this procedure.  In general, keratoprosthesis surgery is complicated, has a narrow safety margin, and requires intensive follow-up, thus a conservative approach is currently recommended by the eye specialists in this area".  Alio and colleagues (2004) reported that corneal keratoprosthesis (BIOKOP I, II) did not provide a stable anatomical relation with the surrounding ocular structures.  Its ability to restore vision is limited to a short post-operative period in eyes implanted with severe ocular surface disease.  The National Institute of Clinical Excellence (NICE, 2004) stated that current evidence on the safety and efficacy of insertion of hydrogel keratoprosthesis does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

There is evidence of the effectiveness of the Boston Keratoprosthesis (K-pro), also known as the Dohlman Doane Boston KPro, for patients with prior failed grafts or as a primary procedure for patients with ocular surface diseases or other conditions that put them at high risk for failed penetrating keratoplasty.  The success rate for K-pro is lower than it is for a low-risk first penetrating keratoplasty in patients with low-risk diagnoses.  But, compared to historical controls, the K-Pro success rate may be higher than for repeat penetrating keratoplasty in patients with prior graft failure and other high-risk diagnoses.

Tan et al (2008) established a multi-disciplinary surgical program for osteo-odonto-keratoprosthesis (OOKP) surgery in Asia and evaluated the safety and effectiveness of this keratoprosthesis in end-stage corneal and ocular surface disease.  A total of 16 adults of Asian ethnic origin, bilaterally blind with end-stage corneal blindness from Stevens-Johnson syndrome, or severe chemical or thermal burns were included in this study.  Osteo-odonto-keratoprosthesis surgery involves 2 procedures-in stage 1, an autologous canine tooth is removed, modified to receive an optical polymethyl methacrylate cylinder, and implanted into the cheek.  The ocular surface is denuded and replaced with full-thickness buccal mucosa.  Stage 2 surgery, performed 2 to 4 months later, involved retrieval of the tooth-cylinder complex and implanting it into the cornea, after reflection of the buccal mucosal flap, corneal trephination, iris and lens removal, as well as anterior vitrectomy.  Concurrent glaucoma and vitreoretinal procedures were also performed at either stage, as required.  Main outcome measures included visual acuity (VA), field of vision, anatomical integrity and stability, as well as ocular and oral complications related or unrelated to the OOKP device.  Osteo-odonto-keratoprosthesis surgery was performed on 15 patients, with a mean follow-up of 19.1 months (range of 5 to 31).  Intra-operative complications included expulsive hemorrhage (keratoprosthesis device not implanted), tooth fracture (n = 1), oronasal fistula (n = 1), and mild inferior optic tilt (n = 1).  Anatomical stability and keratoprosthesis retention has been maintained in all eyes, with no dislocation, extrusion, retro-prosthetic membrane formation, or keratoprosthesis-related infection.  Other complications not directly related to device insertion included retinal detachment (RD) related to silicone oil removal (n = 1) and endophthalmitis related to endoscopic cyclophotocoagulation performed 1 year after OOKP surgery (n = 1).  Eleven patients (73.3 %) attained a stable best spectacle-corrected VA of at least 20/40 or better, whereas 9 (60 %) attained stable 20/20 vision.  Four patients achieved their best visual potential, ranging from 20/100 to counting fingers vision, related to pre-existing glaucomatous optic neuropathy or previous RD.  The authors concluded that establishment of their OOKP program suggested that OOKP surgery has the potential to restore good vision to the most severe cases of corneal blindness in an Asian setting, with minimal device-related complications.  They stated that longer follow-up (5 years) of these cases is currently underway.

In a review on "Corneal transplantation", Tran and colleagues (2012) noted that in cases of multiple failed corneal transplants or ocular surface diesease for which corneal transplants are likely to fail, artificial corneas (keratoprostheses) have an important role.  Several keratoprostheses have been described such as the OOKP, the AlphaCor, and the Boston keratoprosthesis.  The AlphaCor is now rarely used because of complications.  The Boston type 1 keratoprosthesis (both aphakic and pseudophakic versions) is the most widely used and viable alternative to conventional corneal transplantation.

Descemet's stripping automated endothelial keratoplasty (DSAEK) is being investigated as a treatment for corneal endothelial dysfunction.  The procedure employs a mechanical microkeratome to harvest the donor corneal lenticule and mechanical stripping of the diseased host endothelium and Descemet's membrane.  It has been used to treat corneal dysfunction associated with Fuchs' endothelial dystrophy, bullous keratopathy, irido-corneal endothelial syndrome or a failed penetrating graft. Koenig and Covert (2007) reported their early results of DSAEK (n = 26).  They found that despite a smooth graft-host interface, only 2 subjects achieved greater than or equal to 20/25 vision.  The average visual results were comparable to vision after deep lamellar endothelial keratoplasty.  Although patients experienced excellent post-operative acuity with minimally induced surgical astigmatism, nearly 1/3 of the donor lenticules needed to be either re-positioned or replaced.

In a prospective study (n = 9), Mearza and colleagues (2007) reported their clinical experience and 12-month findings of DSAEK.  They concluded that DSAEK provided excellent refractive and reasonable visual outcomes in this limited series, but there were frequent problems with dislocation of the donor tissue, and the graft failure rate was high.  The graft failures may be linked to excessive endothelial damage, and the high dislocation rate may be linked to not filling the anterior chamber totally with air after insertion of the donor.  They stated that further development of the procedure is needed.  Additionally, Price and Price (2007) noted that continued evolution of this relatively new technique will aid to reduce complications and further improve outcomes.

In a retrospective observational case series, Oster et al (2009) characterized the clinical and histological features of primary graft failure after DSAEK.  A total of 16 cases of DSAEK graft failure from 15 patients, all with detailed histological examination of failed graft tissue were included in this study.  Hematoxylin-eosin, periodic acid-Schiff staining, and light microscopy were used to examine the failed DSAEK graft tissue from all patients.  Main outcome measures included examination of specimens for corneal endothelial cell viability and host-donor interface characteristics.  Clinical history revealed that 88 % (14/16) of studied DSAEK grafts detached before failure, and pathological examination found that 75 % (12/16) of failed grafts had atrophic corneal endothelium.  Examples of residual host Descemet's membrane in the graft site and improper donor trephination were also identified.  The authors concluded that marked loss of the corneal endothelium is the prominent feature of primary DSAEK graft failure.  Examples of surgical features, such as incomplete Descemet's stripping and residual full-thickness cornea with a DSAEK graft, were shown.

In a position paper, the American Academy of Ophthalmology (Lee et al, 2009) explains that endothelial keratoplasty procedures offer an alternative to penetrating keratoplasty to replace diseased endothelium with healthy donor tissue, without the need to remove the entire cornea.  Introduced in 1988, deep lamellar endothelial keratoplasty (DLEK), which involves the creation of a deep lamellar pocket and replacement of posterior stroma with healthy donor tissue, allowed more rapid visual rehabilitation and a smaller incision than penetrating keratoplasty, but it was difficult to learn and time consuming.  Descemet's stripping endothelial keratoplasty (DSEK) was introduced in 2005, and Descemet's stripping automated endothelial keratoplasty (DSAEK) was introduced in 2006; these procedures have supplanted DLEK.  These methods for EK involve removal of Descemet's membrane and endothelium and replacement with donor tissue.  When donor tissue is comprised of Descemet's membrane and endothelium alone, the technique is known as Descemet's membrane endothelial keratoplasty (DMEK).  The AAO position paper states that endothelial keratoplasty procedures are associated with a smaller incision and faster visual rehabilitation than penetrating keratoplasty.  The position paper states that there remain concerns about potential complications and long-term efficacy of endothelial keratoplasty, including concerns about graft dislocations, endothelial cell loss, and failed grafts.  The AAO position paper cites the conclusions of an AAO Technology Assessment, which acknowledge the relatively short-term follow up and varying surgical techniques in the literature, but states "there is no evidence that DSAEK carriers unacceptable risks for surgical treatment of endothelial corneal disease. In comparison to PK, DSAEK appears at least equivalent in terms of safety, efficacy, surgical risks, and complications rates and superior to PK in terms of refractive stability, postoperative refractive outcomes, wound and suture-related complications, and intraoperative choroidal hemorrhage risk".

An assessment of endothelial keratoplasty by the National Institute for Health and Clinical Excellence (NICE, 2008) found adequate evidence to support the use of this procedure.  The NICE assessment cited comparative studies which found better visual acuity and a lower incidence of astigmatism with endothelial keratoplasty compared with penetrating keratoplasty.  The specialist advisors to NICE listed adverse events of endothelial keratoplasty reported in the literature or anecdotally as graft dislocation, graft failure and rejection, interface opacification, and loss of best spectacle corrected visual acuity.

Collagen crosslinking is being investigated as a treatment for keratoconus.  Animal studies have shown a significant increase in corneal biomechanical stiffness after collagen crosslinking by combined riboflavin/ultraviolet-A (UVA) treatment.  Riboflavin/UVA-induced collagen crosslinking has been studied, primarily in Europe, as a method for bringing the progression of keratoconus to a halt.  However, most of the current literature is from small, uncontrolled studies with limited follow-up.

In epithelium-off collagen crosslinking (CXL), the epithelium is first abraded with a blunt spatula to allow penetration of riboflavin into the corneal tissue (NICE, 2013). Riboflavin eye drops are applied to the corneal surface before the procedure and intermittently during the procedure. The corneal surface is exposed to UVA radiation. Postoperatively, topical antibiotics and antiinflammatory drops are normally prescribed, with topical steroids if necessary. In some cases, a bandage contact lens may also be used for a few days. The procedure is done on one eye at a time and may also be repeated if needed.

In epithelium-on (transepithelial) CXL, the corneal epithelial surface is left intact (or may be partially disrupted) and a longer riboflavin loading time is needed (NICE, 2013). Sometimes the procedure is used in combination with other interventions such as intrastromal corneal ring segments, photorefractive keratectomy (PRK) or phakic intraocular lens implantation to improve visual acuity. These combination procedures are referred to as 'CXL-plus'.

The mechanism of action of the CXL procedures is not fully understood: they may increase the number of 'anchors' that bond collagen fibers together and strengthen the cornea (NICE, 2013). This is expected to stop the progression of the disease but the duration of benefit is uncertain.

Interim results of a randomized controlled trial of collagen cross-linking with riboflavin and ultraviolet A (UVA) irradiaiton have been published (Wittig-Silva et al, 2008), reporting an apparent stabilization of refractive results.  However, enrollment in the study is not complete and followup has been short.  Subjects with documented progression of keratoconus were separately randomized into either treatment or control groups.  Collagen crosslinking was performed using riboflavin and UVA.  At the time of publication, 66 eyes of 49 patients had been enrolled and randomized.  Interim analysis of treated eyes showed a flattening of the steepest simulated keratometry value (K-max) by an average of 0.74 diopters (D) (p = 0.004) at 3 months, 0.92 D (p = 0.002) at 6 months, and 1.45 D (p = 0.002) at 12 months.  The investigators reported that a non-significant trend toward improvement in best spectacle-corrected visual acuity was also observed.  In the control eyes, mean K-max steepened by 0.60 D (p = 0.041) after 3 months, by 0.60 D (p = 0.013) after 6 months, and by 1.28 D (p < 0.0001) after 12 months.  The investigators reported that best spectacle-corrected visual acuity decreased by logMAR 0.003 (p = 0.883) over 3 months, 0.056 (p = 0.092) over 6 months, and 0.12 (p = 0.036) over 12 months.  The investigators stated that no statistically significant changes were found for spherical equivalent or endothelial cell density.

Coskunseven et al (2009) evalauted the progression of keratoconus in patients treated with collagen cross-linking with riboflavin and ultraviolet A (UVA) irradiation.  A total of 38 eyes of 19 patients with progressive keratoconus were enrolled in a prospective comparative study.  Average follow-up was 9 +/- 2 months (range of 5 to 12 months).  The worse eye was treated with collagen cross-linking, and the fellow eye served as the control.  Corneal epithelium was mechanically removed.  Riboflavin 0.1 % solution in dextran T-500 20 % solution was applied every 2 to 3 minutes for 30 minutes throughout the irradiation.  Ultraviolet A irradiation (370 nm) was performed using a commercially available UVA lamp for 30 minutes.  The group treated with collagen crosslinking demonstrated a mean decrease (less myopic) in spherical equivalent refraction and cylinder of 1.03 +/- 2.22 diopters (D) (range of -5.25 to +3.75 D) and 1.04 +/- 1.44 D (range of -2.00 to +4.00 D), respectively (p < 0.01), and an increase in uncorrected visual acuity (UCVA) and best spectacle-corrected visual acuity (BSCVA) of 0.06 +/- 0.05 (range of 0.00 to 0.20) and 0.10 +/- 0.14 (range of -0.10 to 0.34), respectively (p < 0.01).  The maximal curvature decreased by 1.57 +/- 1.14 D (range of 0.00 to 3.90 D), and intraocular pressure increased by 2 +/- 2 mmHg (range of -1 to 6 mmHg), which was statistically significant.  No statistical difference was noted regarding central corneal thickness (p = 0.06) and endothelial cell count (p = 0.07).  The untreated group showed no statistical difference for any of the clinical parameters, apart from UCVA and BSCVA, which decreased by 0.08 +/- 0.12 (range of -0.40 to 0.10) and 0.06 +/- 0.09 (range of -0.20 to 0.10), respectively (p < 0.01).  The authors concluded that riboflavin/UVA collagen cross-linking appears to be efficacious in inhibiting the progression of keratoconus by reducing the corneal curvature, spherical equivalent refraction, and refractive cylinder in eyes with progressive keratoconus at average 9-month follow-up.

Grewal et al (2009) assessed changes in corneal curvature, corneal elevation, corneal thickness, lens density, and foveal thickness after corneal collagen crosslinking with riboflavin and UVA light in eyes with progressive keratoconus.  Subjective refraction, best corrected visual acuity (BCVA), Scheimpflug imaging, and optical coherence tomography were performed preoperatively and 1 week, 1, 3, and 6 months, and 1 year after crosslinking.  There were no significant differences (p > 0.05) in mean values between pre-operatively and 1 year post-operatively, respectively, in BCVA (0.22 +/- 0.10 and 0.20 +/- 0.10), spherical equivalent (-6.30 +/- 4.50 diopters (D) and -4.90 +/- 3.50 D), or cylinder vector (1.58 x 7( degrees ) +/- 3.8 D and 1.41 x 24( degrees ) +/- 3.5 D).  There was no significant difference in mean measurements between pre-operatively and 1 year post-operatively, respectively, for central corneal thickness (458.9 +/- 40 microm and 455.2 +/- 48.6 microm), anterior corneal curvature (50.6 +/- 7.4 D and 51.5 +/- 3.6 D), posterior corneal curvature (-7.7 +/- 1.2 D and -7.4 +/- 1.1 D), apex anterior (p = 0.9), posterior corneal elevation (p = 0.7), lens density (p = 0.33), or foveal thickness (175.7 +/- 35.6 microm and 146.4 +/- 8.5 microm; p = 0.1).  The authors concluded that stable BCVA, spherical equivalent, anterior and posterior corneal curvatures, and corneal elevation 1 year after crosslinking indicate that keratoconus did not progress.  Unchanged lens density and foveal thickness suggest that the lens and macula were not affected after UVA exposure during crosslinking.
 
Caporossi et al (2010) reported the long-term results of 44 keratoconic eyes treated by combined riboflavin ultraviolet A collagen cross-linking in the first Italian open, non-randomized phase II clinical trial, the Siena Eye Cross Study.  After Siena University Institutional Review Board approval, from September 2004 through September 2008, 363 eyes with progressive keratoconus were treated with riboflavin ultraviolet A collagen cross-linking.  Forty-four eyes with a minimum follow-up of 48 months (mean of 52.4 months; range of 48 to 60 months) were evaluated before and after surgery.  Examinations comprised uncorrected visual acuity, best spectacle-corrected visual acuity, spherical spectacle-corrected visual acuity, endothelial cells count (I Konan, Non Con Robo; Konan Medical, Inc., Hyogo, Japan), optical (Visante OCT; Zeiss, Jena, Germany) and ultrasound (DGH; Pachette, Exton, Pennsylvania, USA) pachymetry, corneal topography and surface aberrometry (CSO EyeTop, Florence, Italy), tomography (Orbscan IIz; Bausch & Lomb Inc., Rochester, New York, USA), posterior segment optical coherence tomography (Stratus OCT; Zeiss, Jena, Germany), and in vivo confocal microscopy (HRT II; Heidelberg Engineering, Rostock, Germany).  Keratoconus stability was detected in 44 eyes after 48 months of minimum follow-up; fellow eyes showed a mean progression of 1.5 diopters in more than 65 % after 24 months, then were treated.  The mean K value was reduced by a mean of 2 diopters, and coma aberration reduction with corneal symmetry improvement was observed in more than 85 %.  The mean best spectacle-corrected visual acuity improved by 1.9 Snellen lines, and the uncorrected visual acuity improved by 2.7 Snellen lines.  The authors concluded that the results of the Siena Eye Cross Study showed a long-term stability of keratoconus after cross-linking without relevant side effects.  The uncorrected visual acuity and best spectacle-corrected visual acuity improvements were supported by clinical, topographic, and wavefront modifications induced by the treatment.

In a prospective, randomized-controlled clinical trial, Greenstein et al (2011) evaluated changes in corneal topography indices after corneal collagen crosslinking (CXL) in patients with keratoconus and corneal ectasia and analyze associations of these changes with visual acuity.  Corneal collagen crosslinking was performed in eyes with keratoconus or ectasia.  Quantitative descriptors of corneal topography were measured with the Pentacam topographer and included 7 indices: (i) index of surface variance, (ii) index of vertical asymmetry, (iii) keratoconus index, (iv) central keratoconus index, (v) minimum radius of curvature, (vi) index of height asymmetry, and (vii) index of height decentration.  Follow-up was 1 year.  The study comprised 71 eyes, 49 with keratoconus and 22 with post-LASIK ectasia.  In the entire patient cohort, there were significant improvements in the index of surface variance, index of vertical asymmetry, keratoconus index, and minimum radius of curvature at 1 year compared with baseline (all p < 0.001).  There were no significant differences between the keratoconus and ectasia subgroups.  Improvements in post-operative indices were not correlated with changes in corrected or uncorrected distance visual acuity.  The authors concluded that there were improvements in 4 of 7 topography indices 1 year after CXL, suggesting an overall improvement in corneal shape.  However, no significant correlation was found between the changes in individual topography indices and changes in visual acuity after CXL.

In a randomized, prospective, and comparative study, Henriquez et al (2011) evaluated the safety and effectiveness of CXL by riboflavin/UV light for the treatment of keratoconus.  This study involved 10 eyes with keratoconus diagnosed between September 2006 and January 2008.  Each patient underwent CXL in the keratoconus eye.  Pre-operative and post-operative (at 1, 3, 6, and 12 months) biomicroscopy examinations, distance uncorrected and best-corrected visual acuities, refractive error, endothelial cell counts, keratometry readings, ultrasound pachymetry, macular thickness, and Scheimpflug analyses were performed and compared.  Mean uncorrected visual acuity was 1.18 logarithm of the minimum angle of resolution pre-operatively and 0.46 logarithm of the minimum angle of resolution at 12 months post-operatively (p < 0.001).  Statistically significant reductions in the mean maximum [2.66 D, p = 0.04] and minimum (1.61 D, p = 0.03) keratometry values were present at 12 months post-operatively, in addition there was a 2.25 D reduction in the mean spherical equivalent (p = 0.01).  At the end of follow-up, 8 (80 %) and 6 (60 %) of the 10 eyes showed a decrease in the anterior and posterior elevation values, respectively, and the thinnest point of the cornea was statistically thinner by a mean of 13.4 μm (p = 0.03).  No statistically significant differences were found between pre-operative and post-operative endothelial cell counts and macular thicknesses.  The improvements in visual acuity, keratometry readings, and spherical equivalent values occurred progressively during follow-up.  The authors concluded that CXL procedure is a safe treatment for keratoconus, yields good visual results, and reduces the progression of the disease, but long follow-up is necessary.

Letko et al (2011) noted that "[d]espite the lack of large multicenter prospective randomized trials, CXL has gradually become a favorite treatment tool and first line treatment for keratoconus and related corneal conditions.  Although available data suggest that CXL administered with the currently widely adopted treatment parameters is safe, effective, and well tolerated, further improvements are likely to come in the future.  One of the improvements is development of protocols that do not require epithelial removal, which will likely lead to reduction of risk for infectious keratitis and stromal scarring, and increase in patient comfort.  Delivery of riboflavin into the cornea through intact epithelium, or through a femtosecond laser-created pocket could become an alternative to currently widely accepted administration of riboflavin that requires removal of the corneal epithelium .... Ultimately, development of topical medications capable of inducing CXL that could be self-administered would further revolutionize treatment of keratoconus and related conditions.  Several drugs including genipin, glutaraldehyde, glyceraldehydes, and aliphatic b-nitro alcohols were identified, but further investigations are needed before any of these compounds could be introduced to clinical practice".

Guidance from the National Institute for Health and Clinical Excellence (NICE, 2013) concluded that there is adequate evidence on the safety and efficacy of epithelium-off CXL using riboflavin and ultraviolet A for keratoconus and keratectasia. NICE found inadequate evidence of the safety and efficacy of epithelium-on (transepithelial) CXL. NICe found that most of the published evidence on photochemical corneal collagen cross-linkage (CXL) using riboflavin and ultraviolet A (UVA) for keratoconus and keratectasia relates to the technique known as 'epithelium-off' CXL'. The NICE guidance explained that "epithelium-on (transepithelial) CXL" is a more recent technique and less evidence is available on its safety and efficacy. The guidance noted that either procedure (epithelium-off or epithelium-on CXL) can be combined with other interventions, and the evidence base for these combination procedures (known as 'CXL-plus') is also limited.

An assessment by the Candian Agency for Drugs and Technologies in Health (CADTH, 2012) found one technology assessment (citing Stenevi, et al., 2011) that concluded that there was low to moderate quality evidence to support the efficacy oof DXL for the treatment of keratoconus. The authors of the technology assessment also concluded that the use of CXL for the treatment of keratoconus represented a lower direct cost to the health care system than corneal transplantation. The assessment reported that the authors of 12 of the 14 randomized and nonrandomized studies included in the asssessment concluded that there was improvement or stability of keratoconus following treatment with CXL. 

Lamellar keratectomy is a surgical procedure used to correct high degrees of myopia, and low-to-moderate amounts of hyperopia.  There is a lack of evidence regarding the effectiveness of lamellar keratectomy for the treatment of epithelial ingrowth following LASIK.

In a retrospective study, Rojas et al (2004) evaluated the safety and effectiveness of mechanical debridement and suturing of the LASIK flap in the treatment of clinically significant epithelial ingrowth after LASIK.  A total of 20 eyes (n = 19 patients) in which clinically significant epithelial ingrowth developed after LASIK were treated with lifting of the flap, scraping of the epithelial ingrowth, and flap suturing.  Primary outcome measurements including recurrence of ingrowth, uncorrected VA, manifest refraction, best spectacle-corrected VA, and complications were evaluated at the last post-operative examination.  At the last post-operative examination (mean +/- SD, 10.5 +/- 14.3 months; range of 1.5 to 64 months), 100 % of eyes had no recurrence of clinically significant epithelial ingrowth.  The uncorrected VA changed from 20/20 or better in 7 eyes (35 %) and 20/40 or better in 15 eyes (75 %) pre-operatively to 20/20 or better in 9 eyes (45 %) and 20/40 or better in 16 eyes (80 %) at the last follow-up examination.  There was no significant change in the mean logarithm of the minimum angle of resolution (logMAR) uncorrected VA before (mean +/- SD, 0.3 +/- 0.5; range of -0.1 to 1.7) and after surgery (mean +/- SD, 0.2 +/- 0.4; range of -0.1 to 1.7) (p = 0.40).  Mean +/- SD spherical equivalent changed from -0.21 +/- 0.82 diopters (D) (range of -1.25 to 1.00 D) pre-operatively to -0.53 +/- 0.89 D (range of -2.50 to 0.38 D) at last follow-up (p = 0.30).  No eyes lost 2 or more lines of best spectacle-corrected VA, and there were no complications associated with the treatment.  The authors concluded that suturing the LASIK flap in addition to mechanical debridement of epithelial ingrowth is a safe and effective treatment for clinically significant epithelial ingrowth after LASIK.

Kymionis et al (2009) reported a patient with severe post-LASIK epithelial ingrowth and keratolysis treated with flap amputation and photo-therapeutic keratectomy (PTK) with adjuvant intra-operative mitomycin C (MMC).  A 55-year-old woman was referred to the authors' department due to severe post-LASIK epithelial ingrowth with corneal melting 2 years after primary LASIK.  The patient had had 2 previous attempts for epithelial ingrowth treatment (flap lift and epithelial ingrowth manual removal) that were unsuccessful.  Slit lamp biomicroscopy and anterior segment optical coherence tomography showed extensive epithelial ingrowth and keratolysis (thinning of the LASIK flap) while the patient had photophobia and could not tolerate contact lenses.  Flap amputation with subsequent PTK (in order to smooth out the corneal irregularities caused by the keratolysis and/or variations in flap thickness) and adjuvant intra-operative MMC application for 2 minutes was performed.  There were no intra- or post-operative adverse events seen during the follow-up period.  Six months after the procedure, uncorrected VA improved to 20/40 compared with 20/50 pre-operatively, while best spectacle-corrected VA improved from 20/40 to 20/32.  The topographical astigmatism was decreased from 3.24 diopters (D) to 1.00 D.  The authors concluded that flap amputation with PTK and adjuvant intra-operative MMC is an option for the management of severe post-LASIK epithelial ingrowth with keratolysis.

Rapuano (2010) reviewed the management of epithelial ingrowth after LASIK.  Data of all patients referred to the Wills Eye Cornea Service after having undergone LASIK were reviewed.  Charts of all patients with the diagnosis of epithelial ingrowth were analyzed.  Data included patient demographics, previous ocular history, visual acuity, size and location of the ingrowth, and management.  Additional data on eyes that underwent removal of the ingrowth at Wills were obtained.  A total of 305 patients (153 females and 152 males, mean age of 44.7 years) were referred for eye problems after LASIK during the study period.  Epithelial ingrowth was confirmed in 46 patients (15 %) (19 females and 27 males, mean age of 47.4 years) involving 55 eyes (27 right and 28 left).  Patients with epithelial ingrowth were seen at a mean of 26 months after LASIK (range of 0.5 to 108 months).  Twenty-four eyes had undergone previous enhancements, 2 twice.  Fourteen eyes had undergone previous removal of epithelial ingrowth, 8 more than once (range of 2 to 8).  In 35 eyes, simple observation was recommended.  In 7 eyes, epithelial removal was recommended to the referring physician.  Thirteen eyes underwent flap lift and epithelial removal at Wills Eye; 9 included flap suturing.  One eye required repeat treatment with flap suturing and fibrin glue, after which no recurrence was found.  In the other 12 eyes, there was no recurrence in 9, small recurrences in 2, and a large recurrence in 1 eye (mean follow-up of 16 months).  The authors concluded that epithelial ingrowth after LASIK is not rare in the authors' referral practice.  Mild ingrowth can be observed, whereas significant ingrowth can respond well to removal with a low chance of significant recurrence.

Elderkin et al (2011) reported the successful treatment of 2 patients who developed flap necrosis preceded by recurrent epithelial ingrowth and interface fluid syndrome after LASIK.  Patient 1 was treated with epithelial debridement and flap suturing; while patient 2 was initially treated with epithelial debridement and flap suturing, but developed recurrent epithelial ingrowth in the right eye and 2 weeks later in the left eye.  Patient 1 developed diffuse interface fluid accumulation in the left eye after epithelial debridement and flap suturing and was treated with timolol meleate 0.5 % solution and methazolamide.  The interface fluid resolved and the cornea and flap became clear.  Slit-lamp examination identified a small area of epithelial ingrowth recurrence, which has remained stable for 3 years.  Patient 2 was successfully re-treated with epithelial debridement followed by fibrin tissue adhesive application.  Five months after debridement and fibrin tissue adhesive, no recurrence of epithelial ingrowth or interface fluid accumulation was noted.  The authors concluded that epithelial ingrowth and interface fluid syndrome may be associated with secondary flap necrosis following LASIK, which can be effectively treated with debridement and flap suturing or fibrin tissue adhesive application.

Hexagonal keratotomy employs a computer-assisted microkeratome to reshape the cornea.  It works similarly to a carpenter’s plane, making a hexagonal pattern of cuts versus the radial cuts seen in RK.  Hexagonal keratotomy has been used for the treatment of hyperopia that occurs naturally, and also for the treatment of presbyopia following RK.  Hexagonal keratotomy is associated with highly variable results and a number of complications have been reported following this procedure, including irregular astigmatism, wound healing abnormalities as well as corneal ectasia (Werblin, 1996; Mehta et al, 2012).  Hexagonal keratotomy is now rarely used since newer techniques in refractive surgery have been developed.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Post-Cataract Post-Transplant Corneal Surgery:
CPT codes covered if selection criteria are met:
65772
65775
Other CPT codes related to the CPB:
65750 - 65755
65770
Other HCPCS codes related to the CPB:
V2100 - V2499 Spectacle lenses
V2500 - V2599 Contact lens
ICD-9 codes covered if selection criteria are met:
367.20 - 367.22 Astigmatism
996.51 Mechanical complication due to corneal graft
V42.5 Cornea replaced by transplant
V45.61 Cataract extraction status
Other ICD-9 codes related to the CPB:
366.00 - 366.9 Cataract
379.31 Aphakia
743.30 - 743.39 Congenital cataract and lens anomalies
V43.1 Lens replaced by other means
Phototherapeutic Keratectomy:
Other CPT codes related to the CPB:
65760
HCPCS codes covered if selection criteria are met:
S0812 Phototherapeutic keratectomy (PTK)
ICD-9 codes covered if selection criteria are met:
139.1 Late effects of trachoma
264.6 Vitamin A deficiency with xerophthalmic scars of cornea
371.00 - 371.05 Corneal scars and opacities
371.42 Recurrent erosion of cornea
371.46 Nodular degeneration of cornea
371.50 - 371.54 Hereditary corneal dystrophies
371.60 - 371.62 Keratoconus
371.82 Corneal disorder due to contact lens
743.41 Anomalies of corneal size and shape
743.42 Corneal opacities, interfering with vision, congenital
743.43 Other corneal opacities, congenital
918.1 Superficial injury of cornea
921.3 Contusion of eyeball
V10.84 Personal history of malignant neoplasm of eye
ICD-9 codes not covered for indications listed in the CPB:
017.3 Tuberculosis of eye
030.0 Lepromatous [type L]
053.21 Herpes zoster keratoconjunctivitis
054.42 Dendritic keratitis
054.43 Herpes simplex disciform keratitis
055.71 Measles keratoconjunctivitis
076.0 - 076.9 Trachoma
090.3 Syphilitic interstitial keratitis
098.43 Gonococcal keratitis
360.21 Progressive high (degenerative) myopia
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
370.04 Hypopyon ulcer
370.05 Mycotic corneal ulcer
370.31 Phlyctenular keratoconjunctivitis
370.44 Keratitis or keratoconjunctivitis in exanthema
370.55 Corneal abscess
Refractive Surgery:
Radial keratotomy:
CPT codes covered if selection criteria are met:
65771
Other HCPCS codes related to the CPB:
V2100 - V2499 Spectacle lenses
V2500 - V2599 Contact lens
ICD-9 codes covered if selection criteria are met:
367.1 Myopia
ICD-9 codes not covered for indications listed in the CPB:
367.0, 367.2 - 367.4 Disorders of refraction (other than myopia)
367.89 Other disorder of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Astigmatic keratotomy (AK):
CPT codes covered if selection criteria are met:
65772
65775
Other CPT codes related to the CPB:
65400 - 65600
ICD-9 codes covered if selection criteria are met:
367.20 - 367.22 Astigmatism
996.51 Mechanical complication due to corneal graft
V42.5 Cornea replaced by transplant
V45.61 Cataract extraction status
ICD-9 codes not covered for indications listed in the CPB:
367.0, 367.1, 367.31 - 367.4 Disorders of refraction (other than astigmatism)
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Other ICD-9 codes related to the CPB:
366.00 - 366.9 Cataract
743.30 - 743.39 Congenital cataract and lens anomalies
V43.1 Lens replaced by other means
Hexagonal keratotomy:
No specific code
ICD-9 codes not covered for indications listed in the CPB:
367.0 Hypermetropia [hyperopia]
367.4 Presbyopia
Other ICD-9 codes related to the CPB:
V45.69 Other states following surgery of eye and adnexa
Laser in-situ keratomileusis:
CPT codes covered if selection criteria are met:
65760
HCPCS codes covered if selection criteria are met:
S0800 Laser in situ keratomileusis (LASIK)
Other HCPCS codes related to the CPB:
V2100 - V2499 Spectacle lenses
V2500 - V2599 Contact lens
ICD-9 codes covered if selection criteria are met:
367.1 Myopia
367.20 - 367.22 Astigmatism
ICD-9 codes not covered for indications listed in the CPB:
367.0, 367.31 - 367.4 Disorders of refraction (other than myopia and astigmatism)
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Standard keratomileusis (ALK):
CPT codes not covered for indications listed in the CPB:
65760
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Epikeratoplasty (or epikeratophakia):
CPT codes covered if selection criteria are met:
65767
Other HCPCS codes related to the CPB:
V2500 - V2599 Contact lens
ICD-9 codes covered if selection criteria are met:
264.6 Vitamin A deficiency with xerophthalmic scars of cornea
371.00 Corneal opacity, unspecified
371.57 Endothelial corneal dystrophy
379.31 Aphakia
743.35 Congenital aphakia
996.51 Mechanical complication due to corneal graft
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Other ICD-9 codes related to the CPB:
364.00 - 364.3 Iridocyclitis
371.70 - 371.73 Other corneal deformities
Keratophakia:
CPT codes not covered for indications listed in the CPB:
65765
Other HCPCS codes related to the CPB:
V2785 Processing, preserving, and transporting corneal tissue
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Other ICD-9 codes related to the CPB:
V42.5 Cornea replaced by transplant
V59.5 Donor, cornea
Lamellar keratoplasty (non-penetrating keratoplasty):
CPT codes covered if selection criteria are met:
65710
0289T
0290T
Other HCPCS codes related to the CPB:
V2785 Processing, preserving, and transporting corneal tissue
ICD-9 codes covered if selection criteria are met:
264.6 Vitamin A deficiency with xerophthalmic scars of cornea
371.00 Corneal opacity, unspecified
371.20 - 371.24 Corneal edema
371.40 - 371.49 Corneal degenerations
371.50 - 371.58 Hereditary corneal dystrophies
371.60 - 371.62 Keratoconus
371.70 - 371.73 Other corneal deformities
743.41 Anomalies of corneal size and shape
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
372.40 - 372.45 Pterygium
Other ICD-9 codes related to the CPB:
V42.5 Cornea replaced by transplant
V59.5 Donor, cornea
Penetrating keratoplasty (PK) (corneal transplantation, perforating keratoplasty):
CPT codes covered if selection criteria are met:
65730
0289T
0290T
HCPCS codes covered for indications listed in the CPB:
V2785 Processing, preserving, and transporting corneal tissue
ICD-9 codes covered if selection criteria are met:
053.21 Herpes zoster keratoconjunctivitis
054.40 Herpes simplex with ophthalmic complications
054.43 Herpes simplex disciform keratitis
139.1 Late effects of trachoma
264.6 Vitamin A deficiency with xerophthalmic scars of cornea
364.21 Fuchs' heterochromic cyclitis
370.00 - 370.8 Keratitis
371.00 - 371.05 Corneal scars and opacities
371.20 - 371.24 Corneal edema
371.40 - 371.49 Corneal degenerations
371.50 - 371.58 Hereditary corneal dystrophies
371.60 - 371.62 Keratoconus
371.71 Corneal ectasia
743.41 Anomalies of corneal size and shape
743.42 Corneal opacities, interfering with vision, congenital
743.43 Other corneal opacities, congenital
871.0 - 871.9 Open wound of eyeball
906.0 Late effect of open wound of head, neck, and trunk
996.51 Mechanical complication due to corneal graft
996.80 Complications of transplanted organ, unspecified
996.89 Complications of other specified transplanted organ
V42.5 Cornea replaced by transplant
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Other ICD-9 codes related to the CPB:
V59.5 Donor, cornea
Photorefractive keratectomy (PRK) and Photoastigmatic keratectomy (PARK or PRK-A):
CPT codes covered if selection criteria are met:
65760
HCPCS codes covered if selection criteria are met:
S0810 Photorefractive keratectomy (PRK)
HCPCS not covered for indications listed in the CPB:
S0596 Phakic intraocular lens for correction of refractive error
Other HCPCS codes related to the CPB:
V2100 - V2499 Spectacle lenses
V2500 - V2599 Contact lens
ICD-9 codes covered if selection criteria are met:
367.0 Hypermetropia
367.1 Myopia
367.20 - 367.22 Astigmatism
ICD-9 codes not covered for indications listed in the CPB:
367.20 - 367.4 Disorders of refraction (other than myopia)
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Intrastromal corneal ring (INTACS):
CPT codes covered if selection criteria are met:
0099T
ICD-9 codes covered if selection criteria are met:
367.0 Hypermetropia
367.1 Myopia
367.20 - 367.22 Astigmatism
371.48 Peripheral degenerations of cornea
371.60 - 371.62 Keratoconus
Other HCPCS codes related to the CPB:
V2100 - V2499 Spectacle lenses
V2500 - V2599 Contact lens
Conductive Keratoplasty (no specific codes):
Other CPT codes related to the CPB:
65771
Other HCPCS codes related to the CPB:
V2100 - V2499 Spectacle lenses
V2500 - V2599 Contact lens
ICD-9 codes not covered for indications listed in the CPB:
367.0 Hypermetropia
367.1 Myopia
367.20 - 367.22 Astigmatism
371.60 - 371.62 Keratoconus
Methods of thermokeratoplasty other than conductive keratoplasty (no specific codes):
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
371.60 - 371.62 Keratoconus
Orthokeratology:
No specific code
Other CPT codes related to the CPB:
92071
92310 - 92326
Other HCPCS codes related to the CPB:
V2500 - V2599 Contact lens
ICD-9 codes not covered for indications listed in the CPB:
367.0 - 367.4 Disorders of refraction
367.89 Other disorders of refraction and accommodation
367.9 Unspecified disorder of refraction and accommodation
Scleral Expansion Surgery:
No specific code
ICD-9 codes not covered for indications listed in the CPB:
367.4 Presbyopia
Intraocular lens implants (clear lens extraction) (aphakic intraocular lenses (IOLS)):
CPT codes not covered for indications listed in the CPB:
66840
66940
66985
HCPCS codes not covered for indications listed in the CPB:
C1780 Lens, intraocular (new technology)
Q1004 New technology intraocular lens category 4 as defined in Federal Register notice
Q1005 New technology intraocular lens category 5 as defined in Federal Register notice
V2630 Anterior chamber intraocular lens
V2631 Iris supported intraocular lens
V2632 Posterior chamber intraocular lens
V2788 Presbyopia correcting function of intraocular lens
ICD-9 codes not covered for indications listed in the CPB:
367.0 Hypermetropia
367.1 Myopia
367.4 Presbyopia
Keratoprosthesis (artificial cornea):
CPT codes covered if selection criteria are met:
65770
HCPCS codes covered if selection criteria are met:
C1818 Integrated keratoprosthesis
L8609 Artificial cornea
Other HCPCS codes related to the CPB:
V2630 Anterior chamber intraocular lens
V2631 Iris supported intraocular lens
V2632 Posterior chamber intraocular lens
ICD-9 codes covered if criteria are met:
053.21 Herpes zoster keratoconjunctivitis
054.40 Herpes simplex with opthalmic complications
054.43 Herpes simplex disciform keratitis
139.1 Late effects of trachoma
264.6 Vitamin A deficiency with xerophthalmic scars of cornea
364.21 Fuch's heterochromic cyclitis
370.00 - 370.8 Keratitis
371.00 - 371.05 Corneal scars and opacities
371.20 - 371.24 Corneal edema
371.40 - 371.49 Corneal degenerations
371.50 - 371.58 Hereditary corneal dystrophies
371.60 - 371.62 Keratoconus
371.71 Corneal ectasia
743.41 Anomalies of corneal size and shape
743.42 Corneal opacities, interfering with vision, congenital
743.43 Other corneal opacities, congenital
871.0 - 871.9 Open wound of eyeball
906.0 Late effect of open wound of head, neck and trunk
996.51 Mechanical complication due to corneal graft
996.80 Complications of transplanted organ, unspecified
996.89 Complications of other specified transplanted organ
V42.5 Cornea replaced by transplant
ICD-9 codes not covered for indications listed in the CPB:
361.00 - 361.9 Retinal detachments and defects
Other ICD-9 codes related to the CPB:
365.0-365.9 Glaucoma
367.0 Hypermetropia
367.1 Myopia
367.4 Presbyopia
370.00 - 371.9 Keratitis, corneal opacity and other disorders of cornea
372.00 - 372.9 Disorders of conjunctiva
743.41 Anomalies or corneal size and shape
743.42 Corneal opacities, interfering with vision, congenital
743.43 Other corneal opacities, congenital
996.51 Mechanical complication due to corneal graft
996.79 Other complications of internal (biological)(synthetic) prosthetic device, implant, and graft
V42.5 Cornea replaced by transplant
V43.89 Other organ or tissue replaced by other means
Endothelial keratoplasty (DSEK, DSAEK, and DLEK):
CPT codes covered if selection criteria are met:
65756
65757
ICD-9 codes covered if selection criteria are met:
371.20 Corneal edema, unspecified
371.21 Idiopathic corneal edema
371.22 Secondary corneal edema
371.23 Bullous keratopathy
371.24 Corneal edema due to wearing of contact lenses
371.33 Rupture in Descemet’s membrane
371.57 Endothelial corneal dystrophy
371.58 Other posterior corneal dystrophies
996.51 Mechanical complication due to corneal graft
996.53 Mechanical complication due to ocular lens prosthesis
ICD-9 codes not covered for indications listed in the CPB:
364.51 Essential or progressive iris atrophy
364.54 Degeneration of pupillary margin [atrophy of sphincter of iris]
364.59 Other iris atrophy
371.48 Peripheral degenerations of cornea
371.52 Other anterior corneal dystrophies
371.60 - 371.62 Keratoconus
371.00 Corneal opacity, unspecified [corneal scar]
371.71 Corneal ectasia
Collagen crosslinking by combined riboflavin/ultraviolet-A (UVA) treatment, Epithelium-off photochemical (CXL) :
No specific code
ICD-9 codes covered for indications listed in the CPB :
371.60 - 371.62 Keratoconus
371.71 Corneal ectasia
743.41 Anomalies of corneal size and shape
Other ICD-9 codes related to the CPB:
V45.69 Other states following surgery of eye and adnexa
Collagen crosslinking, Epithelium-on (transepithelial) collagen cross-linkage (CXL plus) :
No specific code
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
371.60 - 371.62 Keratoconus
371.71 Corneal ectasia
743.41 Anomalies of corneal size and shape


The above policy is based on the following references:
  1. American Academy of Ophthalmology. Radial keratotomy for myopia. Ophthalmology. 1993;100(7):1103-1115.
  2. American Academy of Ophthalmology. Low to moderate refractive errors. Preferred Practice Pattern. San Francisco, CA: American Academy of Ophthalmology; 1991.
  3. American Academy of Ophthalmology. Keratophakia and keratomileusis: Safety and effectiveness. Ophthalmology. 1992;99(8):1332-1341.
  4. U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research. Cataract in Adults: Management of Functional Impairment. Clinical Practice Guideline No. 4, AHCPR Publication No. 93-0544. Rockville, MD: Agency for Health Care Policy and Research; February 1993.
  5. American Academy of Ophthalmology. Refractive errors. Preferred Practice Pattern. San Francisco, CA: AAO; 1997.
  6. American Academy of Ophthalmology. Automated lamellar keratoplasty. Ophthalmology. 1996;103(5):852-861.
  7. American Academy of Ophthalmology. Epikeratoplasty. Ophthalmology. 1996;103(6):983-991.
  8. American Academy of Ophthalmology. Excimer laser photorefractive keratectomy (PRK) for myopia and astigmatism. Ophthalmology. 1999;106(2):422-437.
  9. Waring GO 3rd, Lynn MJ, Fielding B, et al. Results of the prospective evaluation of radial keratotomy (PERK) study 4 years after surgery for myopia. JAMA. 1990;263(8):1083-1091.
  10. American Academy of Ophthalmology. Corneal opacification. Preferred Practice Pattern No. 15. San Francisco, CA: AAO; September 16, 1995.
  11. Bruner WE, Stark WJ, Maumenee AE. Penetrating keratoplasty. In: Manual of Corneal Surgery. WE Bruner, WJ Stark, AE Maumenee, eds. New York, NY: Churchill Livingstone; 1987; Ch. 3, pp.19-28.
  12. Whitson WE, Weisenthal RW, Krachmer JH. Penetrating keratoplasty and keratoprosthesis. In: Duane's Clinical Ophthalmology. Rev. Ed. W Tasman, ed. Philadelphia, PA: Lippincott-Raven; 1997; Vol. 6, Ch. 26, pp.1-28.
  13. Buxton JN, Norden RA. Adult penetrating keratoplasty. Indications and contraindications. In: Corneal Surgery: Theory, Technique, and Tissue. FS Brightbill, ed. St. Louis, MO: C.V. Mosby Co.; 1986; Ch. 6, pp.129-140.
  14. JS Minkowski. Preoperative evaluation and preparation. In: Manual of Corneal Surgery. WE Bruner, WJ Stark, AE Maumenee, eds. New York, NY: Churchill Livingstone; 1987; Ch. 3, pp.7-18.
  15. L'Esperance FA, Serdarevic ON. Laser surgery of the cornea -- the excimer laser. In: Lasers in Ophthalmic Surgery. DB Karlin, ed. Cambridge, MA: Blackwell Science; 1995; Ch. 2, pp.30-66.
  16. Boruchoff SA, Thoft RA. Keratoplasty. In: The Cornea: Scientific Foundations and Clinical Practice. 2nd ed. G Smolin, RA Thoft, eds. Boston, MA: Little, Brown and Co.; 1987; Ch. 15, pp.543-551.
  17. Rapuano CJ, Sugar A, Koch DD, et al.; Ophthalmic Technology Assessment Committee Refractive Surgery Panel. Intrastromal corneal ring segments for low myopia: A report by the American Academy of Ophthalmology. Ophthalmology. 2001;108(10):1922-1928.
  18. Schanzlin DJ, Abbott RL, Asbell PA, et al. Two-year outcomes of intrastromal corneal ring segments for the correction of myopia. Ophthalmology. 2001;108(9):1688-1694.
  19. Colin J, Cochener B, Savary G, et al. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg. 2000;26(8):1117-1122.
  20. McDonald MB, Davidorf J, Maloney RK, et al. Conductive keratoplasty for the correction of low to moderate hyperopia: 1-year results on the first 54 eyes. Ophthalmology. 2002;109(4):637-650.
  21. Asbell PA, Maloney RK, Davidorf J, et al. Conductive keratoplasty for the correction of hyperopia. Trans Am Ophthalmol Soc. 2001;99:79-87.
  22. U.S. Food and Drug Administration, Center for Devices and Radiologic Health. ViewPoint™ CK System. Summary of Safety and Effectiveness and Labeling. PMA No. P010018. Rockville, MD: FDA; April 11, 2002. Available at: http://www.fda.gov/cdrh/pdf/p010018.html. Accessed May 13, 2002.
  23. Waring GO. The challenge of corneal wound healing after excimer laser refractive corneal surgery. J Refract Surg. 1995;11(5). Available at: http://www.slackinc.com/eye/jrs/vol115/9ed2.htm. Accessed June 26, 2002.
  24. Tutton MK, Cherry PM. Holmium:YAG laser thermokeratoplasty to correct hyperopia: Two years follow-up. Ophthalmic Surg Lasers. 1996;27(5 Suppl):S521-S524.
  25. Charpentier DY, Nguyen-Khoa JL, Duplessix M, et al. Radial thermokeratoplasty is inadequate for overcorrection following radial keratotomy. J Refract Corneal Surg. 1994;10(1):34-35.
  26. Neumann AC, Sanders D, Raanan M, DeLuca M. Hyperopic thermokeratoplasty: Clinical evaluation. J Cataract Refract Surg. 1991;17(6):830-838.
  27. Feldman ST, Ellis W, Frucht-Pery J, et al. Regression of effect following radial thermokeratoplasty in humans. Refract Corneal Surg. 1989;5(5):288-291.
  28. Conseil d'Evaluation des Technologies de la Sante du Quebec (CETS). Excimer laser photorefractive keratectomy: the correction of myopia and astigmatism - nonsystematic review. CETS 97-5 RE. Montreal, QC: CETS; 1997.
  29. Silverio Healthcare Management Services. Corneal relaxing incisions. AccuLibrary. AccuChecker [website]. Miami, FL: Silverio and Associates; 2001. Available at: http://www.accuchecker.com/AccuLibrary/articles/eyeocularsurgcornealrelaxingincisions.asp. Accessed July 3, 2002.
  30. American Academy of Ophthalmology (AAO). Policy Statement: Use of unapproved lasers and software for refractive surgery. San Francisco, CA: AAO; revised October 2001.
  31. Sugar A, Rapuano CJ, Culbertson WW, et al. Laser in situ keratomileusis for myopia and astigmatism: Safety and efficacy: A report by the American Academy of Ophthalmology. Ophthalmology. 2002;109(1):175-187.
  32. Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: An evidence-based update. Ophthalmology. 2002;109(3):415-426, 443.
  33. Conseil de Evaluation des Technologies de la Sante (CETS). The excimer laser in ophthalmology: A state-of-knowledge update. CETS 2000-2 RE. Montreal, QC: CETS; 2000.
  34. National Institute for Clinical Excellence (NICE). Laser in situ keratomileusis for the treatment of refractive errors. Interventional Procedure Guidance 102. London, UK: NICE; December 2004. Available at: http://www.nice.org.uk/page.aspx?o=236088. Accessed January 3, 2005.
  35. Hjortdal1 J O, Ehlers N, Moller-Pedersen T, et al. Refractive surgery. An HTA report [summary]. Danish Health Technology Assessment. Copenhagen, Denmark: Danish Centre for Evaluation and Health Technology Assessment (DACEHTA); 2004;4(2).
  36. Mathews S. Scleral expansion surgery does not restore accommodhuman presbyopia. Ophthalmology. 1999;106:873-877.
  37. Singh G. Chalfin S. A complication of scleral expansion surgery for treatment of presbyopia. Am J Ophthal. 2000;130:521-523.
  38. Malecaze FJ, Gazagne CS, Tarroux MC, Gorrand JM. Scleral expansion bands for presbyopia. Ophthalmology. 2001;108:2165-2171.
  39. Vetrugno M, Cardia L. Spontaneous extrusion of a scleral expansion band segment. Ann Ophthalmol. 2001;33:249-251.
  40. Qazi MA, Pepose JS, Shuster JJ. Implantation of scleral expansion band segments for the treatment of presbyopia. Am J Ophthalmol. 2002;134:808-815.
  41. National Institute for Clinical Excellence (NICE). Scleral expansion surgery for presbyopia. Interventional Procedure Guidance No. 70. London, UK: NICE; July 2004. Available at: http://www.nice.org.uk/cms/ip/ipcat.aspx?o=56720. Accessed August 13, 2004.
  42. Packer M, Fine IH, Hoffman RS. Refractive lens exchange with the array multifocal intraocular lens. J Cataract Refract Surg. 2001;28(3):421-424.
  43. Dick HB, Gross S, Tehrani M, et al. Refractive lens exchange with an array mutifocal intraocular lens. J Refract Surg. 2002;18(5):509-518.
  44. Jacobi PC, Dietlein TS, Luke C, Jacobi FK. Multifocal intraocular lens implantation in presbyopic patients with unilateral cataract. Ophthalmology. 2002:109(4):680-686.
  45. Colin J, Cochener B, Savary G, Malet F. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg. 2000;26(8):1117-1122.
  46. Colin J, Cochener B, Savary G, et al. INTACS inserts for treating keratoconus: One-year results. Ophthalmology. 2001;108(8):1409-1414.
  47. Colin J, Velou S. Utilization of refractive surgery technology in keratoconus and corneal transplants. Curr Opin Ophthalmol. 2002;13(4):230-234.
  48. Boxer Wachler BS, Christie JP, Chandra NS, et al. Intacs for keratoconus. Ophthalmology. 2003;110(5):1031-1040.
  49. Colin J, Velou S. Current surgical options for keratoconus. J Cataract Refract Surg. 2003;29(2):379-386.
  50. Colin J, Velou S. Implantation of Intacs and a refractive intraocular lens to correct keratoconus. J Cataract Refract Surg. 2003;29(4):832-834.
  51. Siganos CS, Kymionis GD, Kartakis N, et al. Management of keratoconus with Intacs. Am J Ophthalmol.2003;135(1):64-70.
  52. Letter from Donna Bea Tillman, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, to Darlene Crockett-Billing, Regulatory Consultant, Addition Technology, Sunnyvale, CA regarding INTACS prescription inserts for keratoconus, HDE H040002. Rockville, MD: FDA; July 26, 2004.
  53. Hladun L, Harris M. Contact lens fitting over intrastromal corneal rings in a keratoconic patient. Optometry. 2004;75(1):48-54.
  54. Hofling-Lima AL, Branco BC, Romano AC, et al. Corneal infections after implantation of intracorneal ring segments. Cornea. 2004;23(6):547-549.
  55. Alio JL, Artola A, Ruiz-Moreno JM, et al. Changes in keratoconic corneas after intracorneal ring segment explantation and reimplantation. Ophthalmology. 2004;111(4):747-751.
  56. U.S. Food and Drug Administration (FDA). FDA approves implanted lens to correct nearsightedness. FDA Talk Paper. T03-38. Rockville, MD: FDA; September 13, 2004. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01313.html. Accessed January 19, 2005.
  57. Guo B. Keratoprosthesis for the treatment of severe bilateral cornea disease. Technote TN27. Edmonton, AB: Alberta Heritage Foundation for Medical Research (AHFMR); April 2001.
  58. Alio JL, Mulet ME, Haroun H, et al. Five year follow up of biocolonisable microporous fluorocarbon haptic (BIOKOP) keratoprosthesis implantation in patients with high risk of corneal graft failure. Br J Ophthalmol. 2004;88(12):1585-1589.
  59. National Institute for Clinical Excellence (NICE). Insertion of hydrogel keratoprosthesis. Interventional Procedure Guidance 69. London, UK: NICE; June 2004. Available at: http://www.nice.org.uk/page.aspx?o=208469. Accessed January 13, 2006.
  60. McIntyre L. Osteo-odonto-keratoprosthesis as a treatment for severe corneal opacities. STEER: Succint and Timely Evaluated Evidence Reviews. Bazian, Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; 2001;1(6):1-7.
  61. Mundy L, Merlin T, Bywood P, Parrella A. AlphaCor, artificial cornea: corneal replacement in patients considered at high risk for conventional keratoplasty. Horizon Scanning Prioritising Summary - Volume 4. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2004.
  62. Mundy L, Parrella A. Implantable collamer lens for the correction of myopic vision. Horizon Scanning Prioritising Summary - Volume 7. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2004.
  63. Pichon Riviere A, Augustovski F, Alcaraz A, et al. Myopia surgery with an intraocular lens in severe myopia [summary]. Report IRR No. 75. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2006.
  64. Shortt AJ, Allan BDS. Photorefractive keratectomy (PRK) versus laser-assisted in-situ keratomileusis (LASIK) for myopia. Cochrane Database Syst Rev. 2006;(2):CD005135.
  65. National Institute for Health and Clinical Excellence (NICE). Photorefractive (laser) surgery for the correction of refractive errors. Interventional Procedure Guidance 164. London, UK: NICE; 2006.
  66. Koenig SB, Covert DJ. Early results of small-incision Descemet's stripping and automated endothelial keratoplasty. Ophthalmology. 2007;114(2):221-226.
  67. Mearza AA, Qureshi MA, Rostron CK. Experience and 12-month results of descemet-stripping endothelial keratoplasty (DSEK) with a small-incision technique. Cornea. 2007;26(3):279-283.
  68. Price MO, Price FW. Descemet's stripping endothelial keratoplasty. Curr Opin Ophthalmol. 2007;18(4):290-294.
  69. Glasser A. Restoration of accommodation: Surgical options for correction of presbyopia. Clin Exp Optom. 2008;91(3):279-295.
  70. Tan DT, Tay AB, Theng JT, et al. Keratoprosthesis surgery for end-stage corneal blindness in Asian eyes. Ophthalmology. 2008;115(3):503-510.
  71. Van Meter WS, Musch DC, Jacobs DS, et al. Safety of overnight orthokeratology for myopia: A report by the American Academy of Ophthalmology. Ophthalmology. 2008;115(12):2301-2313.
  72. Oster SF, Ebrahimi KB, Eberhart CG, et al. A clinicopathologic series of primary graft failure after Descemet's stripping and automated endothelial keratoplasty. Ophthalmology. 2009116(4):609-614.
  73. Lee WB, Jacobs DS, Musch DC, et al. Descemet's stripping endothelial keratoplasty: Safety and outcomes: A report by the American Academy of Ophthalmology. Ophthalmology. 2009;116(9):1818-1830.
  74. National Institute for Health and Clinical Excellence (NICE). Corneal endothelial transplantation. Interventional Procedures Consultation. London, UK: NICE; December 2008.
  75. National Institute for Health and Clinical Excellence (NICE). Corneal implants for keratoconus. Interventional Procedure Guidance 227. London, UK: NICE; July 2007.
  76. Medical Advisory Secretariat. Intrastromal corneal ring segments for corneal thinning disorders: An evidence-based analysis. Pre-edit Draft. Ontario Health Technology Assessment Series. April 2009;9(TBA):1-92. Available at: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_intacs_20090327.pdf. Accessed October 30, 2009.
  77. University of Illinois at Chicago (UIC), Department of Ophthalmology and Visual Sciences. Artificial Cornea: The Boston Keratoprosthesis. Department News. Chicago, IL: UIC; undated. Available at: http://www.uic.edu/com/eye/Department/News/KeratoprosthesisInformation%20.pdf. Accessed January 14, 2010.
  78. Chew HF, Ayres BD, Hammersmith KM, et al. Boston keratoprosthesis outcomes and complications. Cornea. 2009;28(9):989-996.
  79. Bradley JC, Hernandez EG, Schwab IR, Mannis MJ. Boston type 1 keratoprosthesis: The University of California Davis experience. Cornea. 2009r;28(3):321-327.
  80. Aldave AJ, Kamal KM, Vo RC, Yu F. The Boston type I keratoprosthesis: Improving outcomes and expanding indications. Ophthalmology. 2009;116(4):640-651.
  81. Zerbe BL, Belin MW, Ciolino JB; Boston Type 1 Keratoprosthesis Study Group. Results from the multicenter Boston Type 1 Keratoprosthesis Study. Ophthalmology. 2006;113(10):1779.e1-7. 
  82. Watson SL, Barker NH. Interventions for recurrent corneal erosions. Cochrane Database Syst Rev. 2007;(4):CD001861.
  83. Ontario Ministry of Health and Long-term Care, Medical Advisory Secretariat (MAS). Phakic intraocular lenses for the treatment of low to high refractive errors: An evidence-based analysis. Toronto, ON: MAS; 2009;9(14).
  84. Barsam A, Allan B. Excimer laser refractive surgery versus phakic intraocular lenses for the correction of moderate to high myopia. Cochrane Database Syst Rev. 2010;(5):CD007679.
  85. Kohnen T, Knorz MC, Cochener B, et al. AcrySof phakic angle-supported intraocular lens for the correction of moderate-to-high myopia: One-year results of a multicenter European study. Ophthalmology. 2009;116(7):1314-1321.
  86. Dick HB, Budo C, Malecaze F, et al. Foldable Artiflex phakic intraocular lens for the correction of myopia: Two-year follow-up results of a prospective European multicenter study. Ophthalmology. 2009;116(4):671-677.
  87. U.S. Food and Drug Administration (FDA). What are phakic lenses? Medical Devices. Rockville, MD: FDA; April 30, 2009. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Implantsand
    Prosthetics/PhakicIntraocularLenses/ucm059237.htm
    . Accessed September 8, 2010.
  88. U.S. Food and Drug Adminstration (FDA). Artisan (Model 206 and 204) phakic intraocular lens (PIOL) Verisyse (VRSM5US AND VRSM6US) phakic intraocular lens (PIOL). Premarket Approval Application No. P030028. Rockville, MD: FDA; September 10, 2004. 
  89. U.S. Food and Drug Administration (FDA). Visian ICL (Implantable Collamer Lens). Premarket Approval Application No. P030016. Rockville, MD: FDA; December 22, 2005.
  90. Kymionis GD, Kontadakis GA, Naoumidi TL, et al. Conductive keratoplasty followed by collagen cross-linking with riboflavin-UV-A in patients with keratoconus. Cornea. 2010;29(2):239-243.
  91. Price MO, Price FW Jr. Endothelial keratoplasty - a review. Clin Experiment Ophthalmol. 2010;38(2):128-140.
  92. National Institute for Health and Clinical Excellence (NICE). Photochemical corneal collagen cross-linkage using riboflavin and ultraviolet A for keratoconus. Interventional Procedure Guidance 320. London, UK: NICE; November 2009. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG320Guidance.pdf. Accessed January 3, 2012.
  93. Health Technology Inquiry Service (THIS). Corneal cross linking with riboflavin for keratoconus: Clinical and cost-effectiveness. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health; April 21, 2010.
  94. Wittig-Silva C, Whiting M, Lamoureux E, et al. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008;24(7):S720-S725.
  95. Coskunseven E, Jankov MR, Hafezi F. Contralateral eye study of corneal collagen cross-linking with riboflavin and UVA irradiation in patients with keratoconus. J Refract Surg. 2009;25(4):371-376.
  96. Grewal DS, Brar GS, Jain R, et al. Corneal collagen crosslinking using riboflavin and ultraviolet-A light for keratoconus: One-year analysis using Scheimpflug imaging. J Cataract Refract Surg. 2009;35(3):425-432.
  97. Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: The Siena eye cross study. Am J Ophthalmol. 2010;149(4):585-593.
  98. Rojas MC, Lumba JD, Manche EE. Treatment of epithelial ingrowth after laser in situ keratomileusis with mechanical debridement and flap suturing. Arch Ophthalmol. 2004;122(7):997-1001.
  99. Kymionis G, Ide T, Yoo S. Flap amputation with phototherapeutic keratectomy (PTK) and adjuvant mitomycin C for severe post-LASIK epithelial ingrowth. Eur J Ophthalmol. 2009;19(2):301-303.
  100. Rapuano CJ. Management of epithelial ingrowth after laser in situ keratomileusis on a tertiary care cornea service. Cornea. 2010;29(3):307-313.
  101. Greenstein SA, Fry KL, Hersh PS. Corneal topography indices after corneal collagen crosslinking for keratoconus and corneal ectasia: One-year results. J Cataract Refract Surg. 2011;37(7):1282-1290.
  102. Henriquez MA, Izquierdo L Jr, Bernilla C, et al. Riboflavin/Ultraviolet A corneal collagen cross-linking for the treatment of keratoconus: Visual outcomes and Scheimpflug analysis. Cornea. 2011;30(3):281-286.
  103. Letko E, Majmudar PA, Forstot SL, et al. UVA-light and riboflavin-mediated corneal collagen cross-linking. Int Ophthalmol Clin. 2011;51(2):63-76.
  104. Reinhart WJ, Musch DC, Jacobs DS, et al. Deep anterior lamellar keratoplasty as an alternative to penetrating keratoplasty. A report by the American Academy of Ophthalmology. Ophthalmology. 2011:118(1):209-218.
  105. Ho C, Cunningham J. Descemet stripping automated endothelial keratoplasty: A review of the clinical and cost-effectiveness. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH). 2009.
  106. Jampel HD, Singh K, Lin SC, et al. Assessment of visual function in glaucoma: A report by the American Academy of Ophthalmology. Ophthalmology. 2011;118(5):986-1002.
  107. Elderkin SJ, Epstein RJ, Seldomridge DL. Successful treatment of recurrent epithelial ingrowth associated with interface fluid syndrome, flap necrosis, and epithelial defects following LASIK. J Refract Surg. 2011;27(1):70-73.
  108. Nanavaty Mayank A, Shortt Alex J. Endothelial keratoplasty versus penetrating keratoplasty for Fuchs endothelial dystrophy. Cochrane Database Syst Rev. 2011;(7):CD008420.
  109. Stenevi U, Claesson M, Holmberg Y, et al. Corneal crosslinking in keratoconus. HTA-rapport 2011:38. Gothenburg, Sweden: The Regional Health Technology Assessment Centre (HTA-centrum); 2011.
  110. Pron G, Ieraci I, Kaulback K. Collagen cross-lining using riboflavin and ultraviolet-A for corneal thinning disorders: An evidence-based analysis. Toronto, ON: Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS); November 2011;11(5). 
  111. Tan DT, Dart JK, Holland EJ, Kinoshita S. Corneal transplantation. Lancet. 2012;379(9827):1749-1761.
  112. National Institute for Health and Clinical Excellence (NICE). Photochemical corneal collagen cross-linkage using riboflavin and ultraviolet A for keratoconus and keratectasia. Interventional Procedure Guidance 466. London, UK: NICE; September 2013.
  113. Canadian Agency for Drugs and Technologies in Health (CADTH). Corneal cross-linking with riboflavin for keratoconus: Clinical and cost-effectiveness. Rapid Response Report: Summary of Abstracts. Ottawa, ON: CADTH; August 21, 2012.
  114. Werblin TP. Hexagonal keratotomy -- should we still be trying? J Refract Surg. 1996;12(5):613-617; discussion 617-620.
  115. Mehta P, Rathi VM, Murthy SI. Deep anterior lamellar keratoplasty for the management of iatrogenic keratectasia occurring after hexagonal keratotomy. Indian J Ophthalmol. 2012;60(2):139-141.


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