Vitrectomy
Number: 0393
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses vitrectomy.
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Medical Necessity
Aetna considers the following medically necessary:
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Vitrectomy for the following conditions:
- Epiretinal membrane with progression or worsening of vision
- Macular hole repair
- Proliferative retinopathy
- Rapidly progressing infectious endophthalmitis
- Removal of silicone oil used in the treatment of retinal detachment
- Retinal detachments secondary to vitreous strands
- RPE65 mutation-associated retinal dystrophy (for administration of voretigene neparvovec-rzyl, see CPB 0927 - Voretigene Neparvovec-rzyl (Luxturna))
- Traumatic penetrating ocular injury
- Vitreous loss incident to cataract surgery
- Vitreoretinal lymphoma
- Vitreous membranes, strands and other opacities due to vitreous hemorrhage or other causes
- Vitreous retraction;
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Vitrectomy face support device (post-vitrectomy face-down support system) for members who have undergone vitrectomy surgery, and who are required to maintain a face down position in the post-operative period.
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Experimental, Investigational, or Unproven
The following procedures are considered experimental, investigational, or unproven because the effectiveness of these approaches has not been established:
- Combined pars plana vitrectomy (PPV) with phacoemulsification (phaco-vitrectomy) for the treatment of retinal detachment (RD);
- Combined PPV with scleral buckling for the treatment of RD;
- Monitoring of intra-ocular pressure during vitrectomy surgery;
- Prophylactic PPV for acute retinal necrosis;
- PPV for the treatment of asymptomatic vitreous floaters.
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Related Policies
Background
Vitrectomy is the surgical removal of the vitreous (transparent gel that fills the eye from the iris to the retina). Vitrectomy may be necessary for the following conditions (CMS, 2006): vitreous loss incident to cataract surgery, vitreous opacities due to vitreous hemorrhage or other causes, retinal detachments secondary to vitreous strands, proliferative retinopathy, and vitreous retraction.
Vitrectomy may be indicated for complications of diabetic retinopathy, including vitreous hemorrhage and retinal detachment. It may also be indicated for persons with traumatic penetrating ocular injury, non-diabetic vitreous hemorrhage, rapidly progressing infectious endophthalmitis, and cataract extractions complicated by a vitreous loss or an underlying inflammatory condition.
Wide fluctuations in intra-ocular pressure (IOP) have been documented during vitrectomy in animal models. Such fluctuations in IOP are posited to have potential adverse effects on retinal and optic nerve function and visual acuity recovery, especially for patients with compromised retinal or optic nerve blood flow and decreased ocular perfusion pressure.
An indirect method of monitoring IOP during vitrectomy surgery has been developed (Armoor Ophthalmics, Houston, TX), which involves placing disposable blood pressure transducers into the line tubing used for vitrectomy infusion. Moorhead et al (2005) reported on a clinical study in which this indirect method of IOP measurement was compared to direct measurement during vitrectomy procedures in 10 patients. Intra-ocular pressure was directly measured by inserting a catheter pressure transducer by an extra pars plana incision directly into the vitreous. During various maneuvers of vitrectomy, including air-fluid exchange and gas-forced fusion, pressure measurements were taken simultaneously from the indwelling pressure transducer and the disposable blood pressure sensors in the infusion line. The directly measured IOP varied between 0 and 120 mm Hg during vitrectomy. The investigators reported in each case how indirectly measured IOP during fluid flow, calculated from infusion line pressures, correlated with the directly measured IOP. The investigators commented that the variation in pressures encountered during these vitrectomy surgeries weree similar to measurements reported during cataract surgery. The investigators stated that it is likely that pressure variations documented in this study may be detrimental, but the physiological significance of these findings requires further study.
Following vitrectomy surgery (e.g., repair of macular hole, retinal detachment), face-down positioning may be required for several weeks to maximize retinal tamponade and, subsequently, hole closure or retinal attachment. The vitrectomy face-down positioning system (also known as a vitrectomy chair or a vitrectomy support system) is a device that may be appropriate in selected cases to assist the patient in maintaining a face down position. The rental of a vitrectomy face support may be necessary for up to 6 weeks after vitrectomy surgery.
Ishikawa et al (2009) evaluated the safety and effectiveness of intra-vitreal injection of bevacizumab (IVB) advanced to vitrectomy for severe proliferative diabetic retinopathy (PDR). A total of 8 eyes of 6 patients (33 to 64 years old, all male subjects) with severe PDR were investigated. An intra-vitreal injection of 1.25 mg bevacizumab was carried out 3 to 30 days before planned vitrectomy. All cases showed minimum bleeding during surgical dissection of fibro-vascular membrane. Two cases receiving bevacizumab 7 days before the surgery showed strong fibrosis and adhesion of fibro-vascular membrane, resulted in some surgical complications. The cases having IVB for shorter time did not show extensive fibrosis. The authors concluded that pre-treatment of bevacizumab is likely effective in the vitrectomy for severe PDR. The appropriate timing of vitrectomy after bevacizumab injection should be further evaluated.
In a review on diabetic retinopathy (DR), Cheung et al (2010) noted that although anti-vascular endothelial growth factor (VEGF) therapy has promising clinical applications for the management of DR, its long-term safety in patients with diabetes has not yet been established. Local adverse events of IVB include cataract formation, infection, retinal detachment, vitreous hemorrhage, as well as potential loss of neural retinal cells. Furthermore, a significant portion of anti-VEGF agents injected into the eye could pass into the systemic circulation. Thus, systemic inhibition of angiogenesis is a potential risk. Also, although clinical trials on the use of intra-vitreal anti-VEGF therapy for the treatment of age-related macular degeneration generally show low (0.6 to 1.2 %) rates of stroke, this risk could be increased in patients with DR because of pre-existing diabetes-related vascular disease.
Nicholson and Schachat (2010) stated that many observational and pre-clinical studies have implicated VEGF in the pathogenesis of DR, and recent successes with anti-VEGF therapy for age-related macular degeneration have prompted research into the application of anti-VEGF drugs to DR. These investigators reviewed the numerous early studies that suggest an important potential role for anti-VEGF agents in the management of DR. The authors concluded that for diabetic macular edema, phase II trials of intra-vitreal pegaptanib and intra-vitreal ranibizumab have shown short-term benefit in visual acuity. Intra-vitreal bevacizumab also has been shown to have beneficial short-term effects on both visual acuity and retinal thickness. For PDR, early studies suggest that IVB temporarily decreases leakage from diabetic neovascular lesions, but this treatment may be associated with tractional retinal detachment. Furthermore, several studies indicate that bevacizumab is likely to prove a helpful adjunct to diabetic pars plana vitrectomy for tractional retinal detachment. Finally, 3 small series suggest a potential beneficial effect of a single dose of bevacizumab to prevent worsening of diabetic macular edema (DME) after cataract surgery. The authors noted that use of anti-VEGF medications for any of these indications is off-label. Despite promising early reports on the safety of these medications, the results of large, controlled trials to substantiate the safety and efficacy of anti-VEGF drugs for diabetic retinopathy are eagerly awaited.
In a prospective, comparative case series, El-Sabagh and colleagues (2011) evaluated the effects of intervals between pre-operative IVB and surgery on the components of removed diabetic fibro-vascular proliferative membranes. A total of 52 eyes of 49 patients with active diabetic fibro-vascular proliferation with complications necessitating vitrectomy were included in this study. Participant eyes that had IVB were divided into 8 groups in which vitreo-retinal surgery was performed at days 1, 3, 5, 7, 10, 15, 20, and 30 post-injection. A group of eyes with the same diagnosis and surgical intervention without IVB injection was used for comparison. In all eyes, proliferative membrane specimens obtained during vitrectomy were sent for histopathologic examination using hematoxylin-eosin stain, immunohistochemistry (CD34 and smooth muscle actin), and Masson's trichrome stain. Main outcome measure was comparative analysis of different components of the fibro-vascular proliferation (CD34, smooth muscle actin, and collagen) among the study groups. Pan-endothelial marker CD34 expression levels starting from day 5 post-injection were significantly less than in the control group (p < 0.001), with minimum expression (1+) in all specimens removed at or after day 30 post-injection. Positive staining for smooth muscle actin was barely detected in the control eyes at day 1, and consistently intense at day 15 and beyond (p < 0.001). The expression level of trichrome staining was significantly high at day 10, compared with control eyes (p < 0.001), and continued to increase at subsequent surgical time points. The author concluded that a pro-fibrotic switch was observed in diabetic fibro-vascular proliferation after IVB, and these findings suggest that at approximately 10 days post-IVB the vascular component of proliferation is markedly reduced, whereas the contractile components (smooth muscle actin and collagen) are not yet abundant. Moreover, the authors noted that their histologic findings are in agreement with many published clinical findings and might be predictive of an optimal time interval for the pre-operative use of adjunctive IVB, which makes surgery more successful with less intra-operative bleeding and complications; thus resulting in better visual outcomes. However, such favorable outcomes need validation from large-scale clinical studies.
Do and colleagues (2013) noted that cataract formation or acceleration can occur after intra-ocular surgery, especially following vitrectomy. The underlying problem that led to vitrectomy may limit the benefit from cataract surgery. In a Cochrane review, these researchers evaluated the safety and effectiveness of surgery for post-vitrectomy cataract with respect to visual acuity, quality of life, and other outcomes. They searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 4), Ovid MEDLINE, Ovid MEDLINE in-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily Update, Ovid OLDMEDLINE (January 1946 to May 2013), EMBASE (January 1980 to May 2013, Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to May 2013), PubMed (January 1946 to May 2013), the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). These investigators did not use any date or language restrictions in the electronic searches for trials. They last searched the electronic databases on May 22, 2013. They planned to include randomized and quasi-randomized controlled trials (RCTs) comparing cataract surgery with no surgery in adult patients who developed cataract following vitrectomy. Two authors screened the search results independently according to the standard methodological procedures expected by The Cochrane Collaboration. They found no randomized or quasi-RCTs comparing cataract surgery with no cataract surgery for patients who developed cataracts following vitrectomy surgery. The authors concluded that there is no evidence from randomized or quasi-RCTs on which to base clinical recommendations for surgery for post-vitrectomy cataract. There is a clear need for RCTs to address this evidence gap. Such trials should stratify participants by their age, the retinal disorder leading to vitrectomy, and the status of the underlying disease process in the contralateral eye. Outcomes assessed in such trials may include gain of vision on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, quality of life, and adverse events such as posterior capsular rupture. Both short-term (6-month) and long-term (1-year or 2-year) outcomes should be examined.
Simunovic et al (2014) performed a meta-analysis of published RCTs regarding the effectiveness of vitrectomy for DME. These investigators searched PubMed and the Cochrane database for randomized, controlled trials investigating vitrectomy for DME. Structural (foveal thickness) and functional (visual acuity) outcomes were used as the primary outcome measures. A total of 11 studies met the criteria for inclusion in this review: these studies were heterogeneous in their experimental and control interventions, follow-up period, and eligibility criteria. Seven studies compared vitrectomy with the natural history of diabetic maculopathy, with laser, or with intra-vitreal corticosteroid injection; 4 studies compared vitrectomy with internal limiting membrane peeling to vitrectomy alone; 1 of the latter 4 studies was the only to investigate vitrectomy in patients with vitreo-macular traction. Meta-analysis suggested a structural, and possibly functional, superiority of vitrectomy over observation at 6 months. Vitrectomy also appears superior to laser in terms of structural, but not functional, outcomes at 6 months. At 12 months, vitrectomy offers no structural benefit and a trend toward inferior functional outcomes when compared with laser. The authors concluded that there is little evidence to support vitrectomy as an intervention for DME in the absence of epiretinal membrane or vitreo-macular traction. They noted that although vitrectomy appears to be superior to laser in its effects on retinal structure at 6 months, no such benefit has been proved at 12 months. Furthermore, there is no evidence to suggest a superiority of vitrectomy over laser in terms of functional outcomes.
An UpToDate review on “Diabetic retinopathy: Prevention and treatment” (Fraser and D’Amico, 2015) states that “Vitrectomy may be beneficial in selective cases of clinically significant ME. However, the results of vitrectomy are somewhat variable, ranging from no benefit to visual acuity gains of several lines or more. Some authors advocate simple removal of the vitreous gel, others recommend additional removal of the thick posterior hyaloid, and still others perform both of these and also remove the internal limiting membrane ("ILM peeling") of the retina itself. A systematic review of trials assessing a combination of these techniques versus observation or focal photocoagulation reported that vitrectomy may be beneficial in some patients with clinically significant ME, particularly in those with evidence of vitreo-macular traction, although the evidence was weak”.
An American Academy of Ophthalmology Preferred Practice Pattern on Diabetic Retinopathy (2014) stated that vitreous surgery is frequently indicated in patients with traction macular detachment (particularly of recent onset), combined traction–rhegmatogenous retinal detachment, and vitreous hemorrhage precluding panretinal photocoagulation. Patients with vitreous hemorrhage and rubeosis iridis also should be considered for prompt vitrectomy and intraoperative panretinal photocoagulation surgery.
Macular Hole Repair
In a Cochrane review, Spiteri Cornish et al (2014) examined if ILM peeling improves anatomic and functional outcomes of full-thickness macular hole (FTMH) surgery when compared with the no-peeling technique. Systematic review and individual participant data (IPD) meta-analysis were undertaken under the auspices of the Cochrane Eyes and Vision Group. Only RCTs were included. Patients with idiopathic stage 2, 3, and 4 FTMH undergoing vitrectomy with or without ILM peeling were included in this analysis. Subjects underwent macular hole surgery, including vitrectomy and gas endotamponade with or without ILM peeling. Primary outcome was best-corrected distance visual acuity (BCdVA) at 6 months post-operatively. Secondary outcomes were BCdVA at 3 and 12 months; best-corrected near visual acuity (BCnVA) at 3, 6, and 12 months; primary (after a single surgery) and final (after greater than 1 surgery) macular hole closure; need for additional surgical interventions; intra-operative and post-operative complications; patient-reported outcomes (PROs) (EuroQol-5D and Vision Function Questionnaire-25 scores at 6 months); and cost-effectiveness. A total of 4 RCTs were identified and included in the review. All RCTs were included in the meta-analysis; IPD were obtained from 3 of the 4 RCTs. No evidence of a difference in BCdVA at 6 months was detected (mean difference, -0.04; 95 % confidence interval [CI]: -0.12 to 0.03; p = 0.27); however, there was evidence of a difference in BCdVA at 3 months favoring ILM peeling (mean difference, -0.09; 95 % CI: -0.17 to -0.02; p = 0.02). There was evidence of an effect favoring ILM peeling with regard to primary (odds ratio [OR], 9.27; 95 % CI: 4.98 to 17.24; p < 0.00001) and final macular hole closure (odds ratio [OR], 3.99; 95 % CI: 1.63 to 9.75; p = 0.02) and less requirement for additional surgery (OR, 0.11; 95 % CI: 0.05 to 0.23; p < 0.00001), with no evidence of a difference between groups with regard to intra-operative or postoperative complications or PROs. The ILM peeling was found to be highly cost-effective. The authors concluded that available evidence supports ILM peeling as the treatment of choice for patients with idiopathic stage 2, 3, and 4 FTMH.
In a Cochrane review, Parravano and colleagues (2015) examined the effects of vitrectomy for idiopathic macular hole on VA. A secondary objective was to investigate anatomic effects on hole closure and other dimensions of visual function, as well as to report on adverse effects recorded in included studies. These investigators searched the Cochrane Eyes and Vision Group Trials Register (March 4, 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 2), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to March 2015), EMBASE (January 1980 to March 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to March 2015), the Web of Science Conference Proceedings Citation Index-Science (CPCI-S) (January 1980 to March 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). They did not use any date or language restrictions in the electronic searches for trials. They last searched the electronic databases on March 4, 2015. These researchers included RCTs comparing vitrectomy (with or without ILM peeling) to no treatment (that is observation) for macular holes. They used standard methodological procedures expected by Cochrane. Two review authors independently extracted the data. They estimated best-corrected visual acuity (BCVA) and macular hole closure at 6 to 12 months of follow-up. A total of 3 studies provided data on the comparison between vitrectomy and observation in eyes with macular hole and VA less than 20/50. Two studies, conducted in the USA and published in 1996 and 1997, used a similar protocol and included participants with stage II macular hole (42 eyes randomized, 36 analyzed, number of participants not reported) or participants with stage III/IV hole (129 eyes of 120 participants, 115 eyes in analyses). The 3rd study, conducted in the UK and published in 2004, included 185 eyes of 174 participants with full-thickness macular hole (41 eyes with stage II holes and 74 eyes with stage III/IV holes in analyses). Studies were of good quality for randomization and allocation concealment, whereas VA measurement was un-masked. At 6 to 12 months, VA was improved by about 1.5 Snellen lines (-0.16 logMAR, 95 % CI: -0.23 to -0.09 logMAR, 270 eyes, moderate-quality evidence). The chances of macular hole closure at 6 to 12 months were greatly increased using vitrectomy, yielding an OR of 31.4 (95 % CI: 14.9 to 66.3, 265 eyes, high-quality evidence; raw sum data: 76 % vitrectomy, 11 % observation). Vitrectomy was beneficial both in smaller (stage II) and in larger (stage III/IV) macular holes. The largest study reported that cataract surgery was needed in about 50 % of cases at 2 years after operation and that retinal detachment occurred in approximately 5 % of operated eyes. The authors concluded that vitrectomy is effective in improving VA, resulting in a moderate visual gain, and in achieving hole closure in people with macular hole.
Prophylactic Pars Plana Vitrectomy for the Treatment of Acute Retinal Necrosis
Liu and co-workers (2018) compared the efficacy of pars plana vitrectomy (PPV) at different time-points to treat acute retinal necrosis (ARN) and to investigate the necessity of PPV for ARN. These researchers carried out a retrospective review of the therapeutic options and outcomes of the ARN patients. A total of 30 ARN patients (34 eyes) were included in this study. The eyes were divided into 3 groups depending on the treatment administered. In the medically treated group, there was no retinal detachment (RD) at the 1st visit. The routine group patients were treated with systemic anti-viral medications, as well as with intra-vitreal anti-viral injections. In the early PPV treatment group, there was no RD at the 1st visit. The early PPV treatment group patients were treated with systemic anti-viral medications and PPV plus silicone oil tamponade and intra-vitreal injection. In the PPV group, there was RD at the 1st visit. The PPV group patients were treated with systemic anti-viral medications and PPV plus silicone oil tamponade and intra-vitreal injection. In the medically treated group, the mean baseline BCVA (logMAR) was 1.38 ± 0.35. The BCVA was 1.21 ± 0.36 at the last visit for the medically treated group. In this group, 1 eye (12.5 %) developed RD after 1 month of treatment. In the early PPV treatment group, the mean BCVA (logMAR) was 1.68 ± 0.26. The BCVA was 1.83 ± 0.21 at the last visit for the early PPV group. In this group, 5 eyes (29.4 %) had recurrent RD before silicone oil removal. In the PPV group, the mean BCVA (logMAR) was 2.0 ± 0.35. The BCVA was 1.72 ± 0.34 at the last visit for the PPV group. In this group, 1 eye (11.1 %) had recurrent RD before silicone oil removal. There were no significant differences among the 3 groups in the baseline BCVA and the BCVA at the last visit (p > 0.05). There were no significant differences between the early PPV group and the PPV group in the recurrent RD rates (p = 0.38). The authors concluded that prophylactic PPV showed no difference in recurrent RD rates or better BCVA; thus, prophylactic vitrectomy could not prevent RD nor improve the prognosis of ARN based on these findings. Moreover, they stated that further studies are needed to ascertain the therapeutic method to decrease the development of PVR.
In a systematic review and meta-analysis, Fan and colleagues (2022) examined the effects of prophylactic vitrectomy for rhegmatogenous retinal detachment (RRD) risk and visual outcome in acute retinal necrosis (ARN). These researchers carried out a systematic search of online databases for articles published between June 1994 and March 202. The main outcome measures, evaluated by a fixed effects model, were RRD risk and visual outcome during a follow-up period. A total of 7 trials involving 265 eyes (121 prophylactic vitrectomy eyes versus 144 routine anti-viral treatment eyes) were analyzed in this study. RRD risk significantly decreased in the prophylactic vitrectomy group compared to the routine anti-viral treatment group (p < 0.001, OR = 0.27, 95 % CI: 0.16 to 0.46, I2 = 35.3 %). Significantly deteriorated visual outcome was observed in the prophylactic vitrectomy group in comparison with the routine anti-viral treatment group (p < 0.001, weighted mean difference [WMD] = 0.47, 95 % CI: 0.26 to 0.67, I2 = 32.2 %). The authors concluded that the findings of this meta-analysis of retrospective cohort studies revealed that prophylactic vitrectomy could reduce the risk of RRD. The silicone oil tamponade and long-term complications may result in deteriorated visual outcome.
Vitrectomy for Congenital Cataract Surgery
In a systematic review and meta-analysis, Cao and colleagues (2019) examined the safety and effectiveness of vitrectomy for congenital cataract surgery. These investigators searched PubMed, Science Direct, the Cochrane Library, China National Knowledge Infrastructure and the Wanfang Database. Two researchers extracted data and assessed paper quality independently. Posterior capsule opacification (PCO) or visual axis opacification (VAO), re-operation rate, VA, intraocular lenses (IOL) deposit, synechias, uveitis, secondary glaucoma, low-contrast sensitivity and IOL decentration were compared. These researchers included 11 RCTs with 634 congenital cataract eyes. Cases of posterior capsule opacification in vitrectomy group were significantly less than that of control group, with risk ratio (RR) of 0.15 [95 % CI: 0.09 to 0.26], and there was no heterogeneity (I2 = 0 %, p = 0.94). Re-operation rate in vitrectomy group was lower than that of control group either (RR = 0.40, 95 % CI: 0.17 to 0.94), and there was no heterogeneity (I2 = 0 %, p = 0.85); BCVA measured in LogMAR unit of vitrectomy group was smaller, with a mean difference (MD) of -0.17 (95 % CI: -0.28 to -0.05), and I2 was only 22 %, indicating of a small heterogeneity. No statistical difference was found between the 2 groups on IOL deposit (RR = 1.23, 95 %CI: 0.70 to 2.17), and the heterogeneity was small (I2 = 16 %, p = 0.31). No statistical difference was found between the 2 groups on synechias (RR = 1.08, 95 % CI: 0.60 to 1.94), with a quite small heterogeneity (I2 = 3 %, p = 0.38). No statistical difference was found between the 2 groups on uveitis (RR = 0.55, 95 %CI: 0.15 to 2.01), and there was no heterogeneity (I2 = 0 %, p = 0.94). There was no statistical difference on IOP either, with a MD of 0.25 (95 % CI: -1.56 to 2.07), and there was no heterogeneity (I2 = 0 %). Egger's test showed that there was no publication bias for all assessed outcomes. Low-contrast sensitivity was better in the vitrectomy group. And no evidence indicated vitrectomy could lead to a higher risk on secondary glaucoma or IOL decentration. The authors concluded that vitrectomy helped lower the PCO risk and re-operation risk after congenital cataract surgery, and also, vitrectomy helped patients gain a better BCVA and achieved a better low-contrast sensitivity, with no trade-off on IOP control, IOL deposit, synechias, uveitis and secondary glaucoma. The authors recommended performing vitrectomy during congenital cataract surgery.
Pars Plana Vitrectomy Combined with Cataract Surgery for Individuals with Diabetes
Xiao and colleagues (2019) stated that PPV is considered to be an essential and effective surgical approach for the management of complications of diabetic retinopathy. Given the high rate of accelerated cataract progression after PPV, PPV combined with cataract surgery appeared to be an attractive therapeutic option for patients with diabetes. However, this combined surgical approach remains controversial in terms of safety and effectiveness. In a meta-analysis, these researchers examined the treatment outcome of PPV with or without cataract surgery. They carried out a systematic search of 3 electronic databases (PubMed, Web of Science, and the Cochrane Library) to identify relevant articles, using the key words "pars plana vitrectomy", "cataract" and "diabetic retinopathy". Main outcome measures included the final VA and post-operative complications. The incidence of post-operative complications was pooled using OR with 95 % CIs in a random effect model; 1 RCT and 4 high-quality retrospective studies met the inclusion criteria and were included in the meta-analysis. In 4 of these studies, final VA did not vary significantly between patients undergoing PPV alone and those undergoing PPV combined with cataract surgery (combined surgery). Only 1 study reported better visual improvement in the combined treatment group. The analysis also showed that most phakic eyes after PPV had cataract progression with varying degrees. In addition, patients receiving PPV alone had a lower risk of neovascular glaucoma (OR 0.36; p < 0.05), iris synechias to anterior capsule (OR 0.36; p < 0.05), and iris rubeosis (OR 0.26; p < 0.05) compared with those receiving combined surgery. The authors concluded that these findings showed that PPV combined with cataract surgery achieved good outcomes without a substantial increased risk to VA or most complications. These researchers stated that given the high rates of cataract progression after PPV, combined surgery may be the more appropriate treatment for patients with diabetes and co-existent visually significant cataract. Moreover, they stated that large prospective, randomized trials are needed to refine these conclusions and examine the long-term effect of the PPV combined with cataract surgery approach in patients with diabetes.
The authors stated that this meta-analysis had several drawbacks. First, very few trials have been published on this issue, with only 1 RCT identified, which may have affected the results to some extent. Thus, further well-designed studies with large samples are needed to substantiate the present findings. Second, some studies included in the meta-analysis were relatively dated, and the relatively old-fashioned surgical methods and strategies reported in these studies may have increased the risk of post-operative complications -- although the sensitivity analysis pointed to a good reliability and stability of the results of this meta-analysis. Third, the results evaluating neovascular glaucoma and vitreous hemorrhage showed large heterogeneity.
Pars Plana Vitrectomy Combined with Scleral Buckle for the Treatment of Giant Retinal Tear
Gutierrez and colleagues (2019) noted that a giant retinal tear (GRT) is a full-thickness neuro-sensory retinal break extending for 90 degrees or more in the presence of a posterior vitreous detachment. In a Cochrane review, these researchers examined the safety and effectiveness of PPV combined with scleral buckle versus pars plana vitrectomy alone for eyes with giant retinal tear. They searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 8), which contains the Cochrane Eyes and Vision Trials Register; Ovid Medline; Embase.com; PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). These investigators did not use any date or language restrictions in their electronic search. They last searched the electronic databases on August 16, 2018. They included only RCTs comparing PPV combined with scleral buckle versus PPV alone for GRT regardless of age, gender, lens status (e.g. phakic or pseudophakic eyes) of the affected eye(s), or etiology of GRT among participants enrolled in these trials. Two review authors independently assessed titles and abstracts, then full-text articles, using Covidence. Any differences in classification between the 2 review authors were resolved through discussion; 2 review authors independently abstracted data and assessed risk of bias of included trials. They found 2 RCTs in abstract format (105 participants randomized). Neither RCT was published in full. Based on the data presented in the abstracts, scleral buckling might be beneficial (RR of re-attachment ranged from 3.0 to 4.4), but the findings were inconclusive due to a lack of peer-reviewed publication and insufficient information for assessing risk of bias. The authors found no conclusive evidence from RCTs on which to base clinical recommendations for scleral buckle combined with PPV for GRT. These researchers stated that RCTs are clearly needed to address this evidence gap. Such trials should be randomized, and patients should be classified by GRT characteristics (extension (90 degrees, 90 to 180 degrees, greater than 180 degrees), location (oral, anterior, posterior to equator)), proliferative vitreoretinopathy stage, and endo-tamponade. Analysis should include both short-term (3 months and 6 months) and long-term (1 year to 2 years) outcomes for primary retinal reattachment, mean change in BCVA, study eyes that required second surgery for retinal re-attachment, and AEs such as elevation of IOP above 21 mmHg, choroidal detachment, cystoid macular edema, macular pucker, proliferative vitreoretinopathy, and progression of cataract in initially phakic eyes.
Pars Plana Vitrectomy for the Diagnosis of Vitreo-Retinal Lymphoma
Hwang and associates (2014) noted that primary intra-ocular lymphoma (PIOL) can present with uveitis, vitritis, or chorio-retinal lesions. While fluorescein angiography (FA), fundus auto-fluorescence (FAF), and optical coherence tomography (OCT) may aid in the diagnosis of PIOL, a definitive diagnosis can only be achieved with tissue analysis. The specimen may be obtained with a vitreous or aqueous tap, however, a diagnostic pars plana vitrectomy with acquisition of diluted and un-dilated vitreous fluid or a chorio-retinal biopsy is preferable. Once a specimen is obtained, cytopathology, flow cytometry, immunohistochemistry (IHC), gene re-arrangement studies with polymerase chain reaction (PCR), and cytokine analysis can be carried out to confirm the diagnosis of PIOL. Treatment is dependent on the presentation of PIOL and may include systemic chemotherapy, local intra-vitreal chemotherapy, radiation or a combination of therapies.
Raufi and colleagues (2015) stated that once primary vitreo-retinal lymphoma (PVRL) is considered in the differential diagnosis, more common causes of ocular inflammation should be eliminated, and directed systemic laboratory testing is usually needed. Definitive diagnosis requires identification of malignant lymphoid cells in the eye. When vitritis is the predominant clinical sign, diagnostic pars plana vitrectomy to obtain both un-diluted and partially diluted vitreous specimens is preferable to aqueous fluid collection or bedside vitreous tap. If multi-focal white subretinal deposits are observed with minimal vitreous cells, a diagnostic vitrectomy may be combined with full-thickness chorio-retinal biopsy or needle aspiration of subretinal material. Repeat biopsies may be required.
Pulido and co-workers (2018) stated that to make a diagnosis of PVRL, it is important to determine the region of the eye with the most cellular involvement with lymphoma. The anterior chamber rarely has many cells; thus, sampling of the anterior chamber is not usually advised. The eye that has the most vitreous cells should be biopsied; and if the patient has been placed on systemic or local corticosteroids, it is best to wait a few weeks to allow more of a vitreal infiltration before doing a vitreous biopsy. In the meantime, if a magnetic resonance imaging (MRI) of the brain has not been performed in the last 2 to 3 months, it should be carried out a few weeks following stoppage of the use of corticosteroids to ensure no central nervous system (CNS) lesion has developed. With small-gauge vitrectomy instruments, the risks of the vitreous biopsy have been decreased significantly. Moreover, it is still important to close the sclerotomies with an absorbable suture to avoid the possibility of cells leaking out. Furthermore, these researchers stated that targeted next-generation sequencing (NGS) on small volumes of vitrectomy fluid has promise in aiding the diagnosis of PVRL.
Giuffre and colleagues (2020) noted that the diagnosis of PVRL cannot be defined without clinical ocular examination and imaging techniques; however, under clinical suspect, the gold standard for definite PVRL diagnosis remains histopathologic examination of the ocular specimens, with demonstration of malignant B lymphocytes in the vitreous or retina, and IHC to characterize lymphocyte type and clonality. Vitreous biopsy is the procedure that is most often performed in clinical setting. Conversely, chorio-retinal biopsy is confined to challenging or doubtful cases (e.g., when the vitreous biopsy has not been detrimental; and the disease is progressing despite the treatment). Trans pars plana vitrectomy with 25- or 27-G instrumentation is the gold standard. Low vitrector cut rate (600 cuts/min or less) under air infusion is the preferable technique for diagnostic vitrectomy, to avoid cell damage and globe hypotony. Un-diluted sample is collected for cytopathological evaluation.
On behalf of the Study Group for Vitreoretinal Lymphoma Diagnostics, Carbonell et al (2021) provided recommendations for diagnosis of VRL. These investigators reviewed the literature for reports supporting the diagnosis of VRL. A questionnaire (Delphi 1 round) was distributed to 28 participants. In the 2nd round (Delphi 2), items of the questionnaire not reaching consensus (75 % agreement) were discussed to finalize the recommendations. Presenting symptoms include floaters and painless loss of vision, vitreous cells organized into sheets or clumps. Retinal lesions are usually multi-focal creamy/white in the outer retina. Other findings include retinal lesions with "leopard-skin" appearance and retinal pigment epithelium atrophy. Severe vitreous infiltration without macular edema is the most likely presentation. Diagnostic vitrectomy should be performed. Systemic corticosteroid should be discontinued at least 2 weeks before surgery. An interleukin (IL)-10:IL-6 ratio of greater than 1, positive mutation for the myeloid differentiation primary response 88 gene and monoclonality are indicators of VRL; and multi-modal imaging (OCT, FAF) are recommended. The authors concluded that a consensus meeting allowed the establishment of recommendations important for the diagnosis of VRL.
Combined Pars Plana Vitrectomy with Phacoemulsification (Phacovitrectomy) for the Treatment of Retinal Detachment
In a retrospective, case-series study, Tan et al (2021) compared the anatomical and functional results of combined PPV and phacoemulsification (phacovitrectomy) and PPV alone for the treatment of phakic rhegmatogenous retinal detachment (RRD). This trial included 266 phakic eyes that underwent either phacovitrectomy or PPV alone for primary retinal detachment. The primary anatomical success rate, the final BCVA, and the refractive outcomes were analyzed. A total of 127 eyes were included in the phacovitrectomy group and 139 in the PPV group. The primary anatomical success rate was 84.3 % in the phacovitrectomy group and 89.2 % in the PPV group (p = 0.311); 109 (78.4 %) eyes of the PPV group required cataract removal for visual rehabilitation during the follow-up period. There was no significant difference between the 2 groups in terms of the mean final BCVA (p = 0.185) and mean visual changes (p = 0.470). Overall, combined cataract extraction resulted in a significant myopic shift compared with delayed cataract surgery (p = 0.047). The authors conclude that phacovitrectomy was a safe and effective procedure for the treatment of RRD. The anatomical and functional results were comparable with those obtained with PPV and delayed cataract surgery. However, the refractive outcomes were less favorable and shifted toward myopia, especially in macula-off cases. Moreover, these researchers stated that further prospective, randomized, comparative studies are needed to confirm these findings.
The authors stated that this study had several drawbacks mainly related to its retrospective design. First, the BCVA was measured using a projected-light Snellen chart. An early treatment diabetic retinopathy study type measurement would have been more accurate and reproducible, especially in eyes with a low VA. Second, the indication for combined cataract extraction was left to the judgement of the surgeon based on the degree of lens opacity and patient age, which may represent a selection bias. Third, patients in the PPV group who underwent subsequent phacoemulsification outside the authors’ department were excluded from the analysis of refractive results. Although it may be considered as a drawback, these investigators believed that including these patients would have resulted in a significant bias given the variations in the biometry measurement and IOL type selection. Fourth, the follow-up period was not standardized, and the BCVA assessment should have been obtained at the same intervals following surgery to compare the 2 procedures regarding the post-operative visual recovery. However, these researchers believed that, when comparing phacovitrectomy and vitrectomy alone in phakic patients, the main issue is to determine whether post-vitrectomy cataract has an influence on visual rehabilitation. This analysis could demonstrate that the visual recovery was shorter in the combined group; however, the final BCVA did not differ between the 2 approaches following cataract removal in the PPV group.
In a systematic review and meta-analysis, Mirshahi et al (2023) compared the visual, refractive, and anatomical outcomes and incidence of complications between phacovitrectomy versus PPV-only in phakic eyes with RRD. Two independent reviewers searched Medline, Cochrane Central, and Web of Science to identify relevant studies. Prospective or retrospective studies comparing PPV-only and phacovitrectomy for RRD were included. Recruited studies provided information regarding at least anatomical success or refractive outcomes. Meta-analysis was carried out for single surgery success rate, final BCVA, post-operative complications, mean predicted refractive error, and mean absolute predicted refractive error. A total of 7 studies (788 eyes) were selected, including 2 clinical trials and 5 retrospective comparative case-series studies. The single surgery success rate was similar in PPV-only and phacovitrectomy groups (RR = 1.02; 95 % CI: 0.95 to 1.10; p = 0.57). Mean final BCVA was significantly better in the PPV-only group than the phacovitrectomy group (MD = 0.06; 95 % CI: 0.00 to 0.12; p = 0.04). The risk of epiretinal membrane formation was significantly higher in eyes that underwent phacovitrectomy than PPV-only (RR = 2.85; 95 % CI: 1.5 to 5.41; p = 0.001). Phacovitrectomy group showed a more myopic final mean predicted refractive error than PPV-only group (MD = -0.31; 95 % CI: -0.55 to -0.07; p = 0.01). The authors concluded that there was no significant difference between the 2 groups regarding the anatomical outcome. Slightly better visual and refractive results were observed in the PPV-only group. However, these researchers stated that these findings should be interpreted with caution as the majority of included studies were low-quality retrospective studies.
Combined Pars Plana Vitrectomy with Scleral Buckling for the Treatment of Retinal Detachment
Nichani et al (2022) noted that the safety and effectiveness of scleral buckling (SB) versus combination SB and PPV (SB + PPV) for the treatment of RRD repair remains unclear. In a meta-analysis, these investigators identified comparative studies published from January 2000 and June 2021 that reported on the safety and/or effectiveness following SB and SB + PPV for RRD repair. Final BCVA represented the primary endpoint, while re-attachment rates and ocular adverse events (AEs) were secondary endpoints. A random-effects meta-analysis was carried out, and 95 % CIs were calculated. A total of 18 studies (3,912 SB and 3,300 SB + PPV eyes) were included. Final BCVA was non-significantly different between SB and SB + PPV (20/38 versus 20/66 Snellen; weighed MD [WMD] = -0.11 LogMAR; 95 % CI: -0.29 to 0.07; p = 0.23). Primary re-attachment rate was similar between procedures (p = 0.74); however, SB alone achieved a significantly higher final re-attachment rate (97.40 % versus 93.86 %; RR = 1.03; 95 % CI: 1.00 to 1.06; p = 0.04). Compared to SB + PPV, SB alone had a significantly lower risk of post-operative macular edema (RR = 0.69; 95 % CI: 0.47 to 1.00; p = 0.05) and cataract formation (RR = 0.34; 95 % CI: 0.12 to 0.96; p = 0.04). The incidence of macular hole, epiretinal membrane, residual subretinal fluid, proliferative vitreoretinopathy, elevated IOP, and extra-ocular muscle dysfunction were similar between SB and SB + PPV. The authors concluded that there was no significant difference in final BCVA between SB + PPV and SB alone in RRD. SB alone offered a slightly higher final re-attachment rate along with a reduced risk of macular edema and cataract. Primary re-attachment rate and the incidence of other complications were similar between the 2 procedures. Moreover, these researchers stated that while these conclusions may not be true among all patient subgroups, the present study demonstrated that combination SB + PPV may be unnecessary in certain uncomplicated RRDs. In complicated cases, data are less clear on the role of SB + PPV and the decision to pursue combination procedures should be left to the surgeon’s discretion based on individual patient factors. These investigators recommended further evaluation of the safety and effectiveness outcomes for SB and SB + PPV in diverse subgroups in addition to cost-effectiveness analyses and patient-provider experience measures to guide future clinical decision-making.
Eshtiaghi et al (2022) stated that it is unclear if there are differences in safety and effectiveness between PPV alone and PPV with a supplemental SB (PPV-SB) for the treatment of RRD. In a meta-analysis, these investigators compared the safety and effectiveness of these surgical procedures. Ovid Medline, Embase, and Cochrane Library were systematically searched (January 2000 to June 2021). The primary outcome was the final BCVA, whereas the secondary outcomes were re-attachment rates and complications. The risk of bias was assessed using the Cochrane risk-of-bias tool for RCTs and the risk of bias in non-randomized studies of interventions tool for non-randomized studies. This study included 15,661 eyes from 38 studies (32 observational studies and 6 RCTs). The median follow-up duration was 6 months. The final BCVA was similar between PPV and PPV-SB (WMD, -0.03 logarithm of the minimum angle of resolution [-0.14 to 0.07]; p = 0.55). There was a significant difference in the single-operation success rate (SOSR) (88.2 % versus 86.3 %; RR, 0.97 [0.95 to 1.00]; p = 0.03), favoring PPV-SB; however, there was no significant difference in the final re-attachment rate (RR, 1.00 [0.99 to 1.01]; p = 0.56). PPV required a significantly higher number of operations to achieve final anatomical re-attachment (WMD, 0.13 [0.02 to 0.24]; p = 0.02). In terms of complications, PPV was significantly less likely to be associated with macular edema (RR, 0.47 [0.25 to 0.88]; p = 0.02) and epiretinal membrane formation (RR, 0.70 [0.52 to 0.94]; p = 0.02); however, these differences were no longer significant in studies published after 2010 or in RCTs. Significant proliferative vitreoretinopathy, lens status, and macular attachment status did not mediate differences in these effects. The authors concluded that there were no significant differences in the final VA outcomes between PPV and PPV-SB. PPV-SB was associated with a greater SOSR than standalone PPV, although the magnitude of the effect was small, with a high number needed to treat . The final re-attachment rate was similar. In recent studies and in RCTs, the risk of complications was similar between the procedures.
Pars Plana Vitrectomy for the Treatment of Asymptomatic Vitreous Floaters
In a systematic review and meta-analysis, Dysager et al (2022) examined the safety and effectiveness of PPV in the treatment of patients with primary symptomatic vitreous floaters. These investigators searched 12 databases for studies performing PPV for primary symptomatic vitreous floaters with at least 3 months follow-up; 2 authors reviewed the studies and extracted data. While the main outcome of interest was patient satisfaction/reduction of symptoms/quality of life (QOL), other measures of safety and effectiveness were also extracted. Where possible, meta-analyses were carried out to provide summary estimates. These researchers identified 18 eligible studies, which included 2,077 eyes of 1,789 patients. Studies reported that at least 90 % of the patients were satisfied or had relief of symptoms. BCVA improved -- 0.08 logMAR (95 % CI: - 0.10 to - 0.06 logMAR, p < 0.0001). Contrast sensitivity improved -- 2.26 % (95 % CI: - 3.26 % to - 1.26 %, p < 0.0001). After surgery, cataract occurred in 31.7 % (95 % CI: 21.7 % to 42.7 %), retinal tears/breaks in 2.92 % (95 % CI: 1.38 % to 4.97 %), vitreous hemorrhage in 1.97 % (95 % CI: 0.83 % to 3.54 %), macular edema in 1.70 % (95 % CI: 0.84 % to 2.83 %), retinal detachment in 1.54 % (95 % CI: 0.62 % to 2.82 %), glaucoma in 1.04 % (95 % CI: 0.53 % to 1.73 %), and endophthalmitis in 0.18 % (95 % CI: 0.02 % to 0.45 %). The authors concluded that post-operative patient satisfaction was high following PPV for primary symptomatic vitreous floaters; however, patients should be carefully counselled as what to expect from the treatment and understand the risks associated with PPV. Moreover, these researchers stated that for patients with asymptomatic vitreous floaters, treatment should not be encouraged in any circumstances considering the safety profile of the PPV.
PPV for the Treatment of Epiretinal Membrane
In a retrospective, cohort study, Rayess et al (2021) compared rates of re-operation in patients with idiopathic epiretinal membrane (ERM) who received PPV with or without inner limiting membrane (ILM) peeling and to examine trends in the overall use of ILM peeling over time. Participants of this trial were patients included in the IBM Marketscan database between January 1, 2008, and December 31, 2016, who underwent surgery for idiopathic ERM. Procedure claims with laterality codes were used to determine patients with idiopathic ERM who received PPV with or without ILM peel between 2008 and 2016, and to identify cases of re-operation and subsequent retinal detachment within 1 year of index surgery. The primary outcome was rate of re-operation for recurrent ERM according to whether or not patients receive an ILM peel during their index ERM surgery. These investigators also examined trends for index ERM surgery (ILM peel or no ILM peel) between 2008 and 2016, and the risk of developing retinal detachment within 1 year of the index ERM surgery. A total of 10,114 patients received ERM surgery and met inclusion criteria (5,310 without ILM peel, and 4,804 with ILM peel). The re-operation rate was significantly lower among patients who received PPV with ILM peel (0.88 %) compared with patients without ILM peel (1.48 %; p = 0.007). In 2008, PPV without ILM peel represented 70 % of ERM procedures, but PPV with ILM peeling accounted for 52 % and 70 % of ERM procedures in 2013 (p < 0.001) and 2016 (p < 0.001), respectively. The rates of retinal detachment were similar between patients who received an ILM peel (0.79 %) and patients who did not receive an ILM peel (0.92 %) during their primary ERM surgery (p = 0.474). The authors concluded that the increasing use of PPV with ILM peeling to address ERM removal was associated with significantly reduced re-operation rates within 1 year. Moreover, these researchers stated that future studies are needed to determine the cost-effectiveness of performing an ILM peel for initial idiopathic ERM repairs and evaluate long-term visual and structural changes related to ILM peeling.
Daud et al (2023) stated that the standard of care (SOC) for macular hole (MH) and ERM is vitrectomy, which increases the risk of developing cataract. Combined phacovitrectomy eliminates the need for a 2nd surgery. In a systematic review and meta-analysis, these investigators examined the safety and effectiveness between combined and sequential PVV and phacoemulsification for MH and ERM. Ovid Medline, Embase, and Cochrane CENTRAL were searched in May 2022 for all studies comparing combined versus sequential phacovitrectomy for MH and ERM. The primary outcome was mean BCVA at 12 months follow-up. Meta-analysis was carried out using a random effects model. Risk of bias (RoB) was assessed using the Cochrane RoB 2 tool for RCTs, and Risk of Bias in non-randomized studies of interventions tool for observational studies. Of the 6,470 studies found, 2 RCTs, and 8 retrospective, comparative, non-randomized studies were identified. Total eyes for combined and sequential groups were 435 and 420, respectively. Meta-analysis suggested no significant difference between combined and sequential surgery for 12-month BCVA (combined = 0.38 logarithm of the minimum angle of resolution [logMAR]; sequential = 0.36 logMAR; mean difference = + 0.02 logMAR; 95 % CI: -0.04 to 0.08; p = 0.51; I2 = 0 %; n = 4 studies, 398 participants), as well as absolute refractive error (p = 0.76; I2 = 97 %; n = 4 studies, 289 participants), risk of myopia (p = 0.15; I2 = 66 %; n = 2 studies, 148 participants), MH non-closure (p = 0.57; I2 = 48 %; n = 4 studies, 321 participants), cystoid macular edema (CME) (p = 0.15; I2 = 0 %; n = 6 studies, 526 participants), high IOP (p = 0.09; I2 = 0 %; n = 2 studies, 161 participants), posterior capsule opacification (p = 0.46; I2 = 0 %; n = 2 studies, 161 participants), posterior capsule rupture (p = 0.41; I2 = 0 %; n = 5 studies, 455 participants), and retinal detachment (p = 0.67; I2 = 0 %; n = 6 studies, 545 participants). The authors concluded that no significant difference was observed between combined and sequential surgeries for visual outcomes, refractive outcomes, or complications. Moreover, these researchers stated that given that most studies were retrospective in design and contained a high RoB, future high-quality RCTs are needed.
Mihalache et al (2024) noted that the safety and effectiveness of PPV with ILM peeling remains poorly understood for the treatment of ERM. In a systematic review and meta-analysis, these investigators compared the safety and effectiveness of PPV with and without ILM peeling for ERM. They carried out a systematic literature search on Ovid Medline, Embase, Cochrane Library, and Google Scholar from January 2000 to January 2023 for comparative studies reporting visual and anatomical outcomes for patients with ERM that received PPV with or without ILM peeling. Primary outcomes included BCVA at last study observation and change in BCVA from baseline. Secondary outcomes included retinal thickness (RT) at last study observation, change in RT from baseline, risk of ERM recurrence, and AEs. A random-effects meta-analysis was carried out. Risk of bias of RCTs was assessed using the Risk of Bias 2 tool of observational studies using the Risk of Bias in Non-randomized Studies of Interventions-I tool. The certainty of evidence of outcomes was evaluated using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. A total of 19 studies reporting on 1,291 eyes at baseline were included. PPV with and without ILM peel achieved a similar BCVA at last study observation (p = 0.68) and change in BCVA from baseline (p = 0.79). These findings remained consistent irrespective of whether simultaneous phacoemulsification was performed. PPV with ILM peel achieved a significantly lower incidence of ERM recurrence (RR = 0.26, 95 % CI: 0.13 to 0.51], p < 0.0001) and additional surgery (RR = 0.17, 95 % CI: 0.04 to 0.74], p = 0.02) compared to PPV without ILM peel. The authors concluded that this meta-analysis found that PPV with and without ILM peel provided similar improvements to VA in patients with ERM. PPV without ILM peel achieved a reduced RT at last study observation. Nevertheless, patients treated with PPV and ILM peel exhibited a lower recurrence of ERM and lower rates of additional surgery. Moreover, these researchers stated that given the moderate certainty of evidence associated with many of the outcomes, they recommend that future RCTs examine the safety and effectiveness of PPV with and without ILM peel in diverse patient populations to allow for more nuanced treatment decision-making.
These investigators stated that a paucity of RCT evidence and low sample sizes across outcomes limited the strength of this meta-analysis, resulting in very low-to-moderate certainties of evidence. As well, the significance of some outcomes in this meta-analysis changed after a leave-one-out sensitivity analysis. The substantial heterogeneity associated with a few outcomes limited the generalizability of the conclusions. The use of adjuvants for ILM staining differed across studies and may have also influenced outcomes. For example, it was plausible that indocyanine green (ICG) toxicity may have affected VA; however, corroborating data for this was not directly provided by the included studies. Moreover, trypan blue and triamcinolone acetonide (TA) are not considered ILM-specific, which may result in incomplete ILM peeling. Inconsistent reporting of safety and effectiveness outcomes limited the number and robustness of comparisons. Different studies reported on BCVA or RT at last study observation and change in BCVA or RT from baseline, resulting in inconsistent findings. Metamorphopsia, which tended to occur in ERM eyes undergoing PPV with or without ILM peeling, could not be analyzed due to the reporting of different metrics across studies. Some eyes that did not receive simultaneous phacoemulsification were included in the simultaneous phacoemulsification subgroup analysis, as many included studies reporting on eyes receiving simultaneous phacoemulsification did not provide data stratified by this criterion. This meta-analysis found that PPV without ILM peeling was associated with a lower RT than PPV with ILM peeling but a higher incidence of ERM recurrence. Although recurrent ERMs may be indicative of an increased RT, it is possible that the incidence of ERM recurrence (2.7 % in the ILM peel group and 15.7 % in the non-ILM peel group) was too low in the non-ILM peel group to meaningfully increase the group’s mean RT and future research is needed to better understand the relationship between RT outcomes and ILM peeling. These researchers stated that results of this study should be interpreted only at the level of the cohort and not at the level of individual patients. Conclusions must be regarded as hypothesis-generating.
Vitrectomy for Removal of Silicone Oil Used in the Treatment of Retinal Detachment
In a systematic review and meta-analysis, Feng et al (2017) examined the differences between silicone oil (SO) and other vitreous tamponades or placebo in performing pars plana vitrectomy (PPV). This study was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A total of 7 databases and the reference lists of the retrieved randomized controlled trials (RCTs) were searched to identify eligible studies. The primary outcomes were the rate of re-detachment after endo-tamponade removal, the rate of re-operation, and poor visual acuity (VA). The secondary outcomes were adverse events (AEs) and quality of life (QOL) related to post-operative position. A total of 10 articles (12 trials) were included. There were no significant differences between silicone oil and other agents in most of the primary and second outcomes. Only the risk of hypotony was found to be significantly lower when filling with SO, compared with other agents. No study reported the QOL related to post-operative position. The authors concluded that there was no significant difference in the risk of poor outcomes between PPV with SO and that with other vitreous tamponades with different surgical histories.
He et al (2018) noted that vitrectomy with SO tamponade is an effective approach for the treatment of complicated retinal detachment (RD) and has improved the prognosis of severe vitreoretinal diseases. Long-term SO tamponade could result in oil-related complications such as cataract, glaucoma, emulsification, and keratopathy; thus, the oil is usually removed after a certain period of time. Silicone oil removal (SOR) improves the visual function and can reduce the oil-related complications.
Shah et al (2018) stated that PPV in combination with intra-ocular tamponade with silicone oil is a standard technique in the treatment of complex retinal detachment. Although the use of silicone oil has improved the results of retinal detachment surgery, its removal is recommended due to the ocular complications related to its long-term use; however, retinal re-detachment can occur after silicone oil removal. In a retrospective study, these investigators examined the anatomical and visual outcome following silicone oil removal (SOR) in eyes with complicated retinal detachment. They analyzed 64 eyes of 64 consecutive patients of silicone oil removal over a period of 12 months. All eyes had undergone standard 3 ports PPV with silicone oil placement for complicated retinal detachment. Cases that completed at least 1 month follow-up duration after SOR were included in the study. Anatomical success following SOR was achieved in 56 of 64 eyes (87.5 %); 7 of 8 re-detachments (87.5 %) were observed in eyes with silicone oil tamponade duration of less than 6 months. VA improved or was stabilized in 49 of 64 eyes (76.6 %). Using paired t-test, it was found that there was no significant difference in pre- and post-SOR VA. Post-operative ocular hypertension, corneal decompensation, band shaped keratopathy and hypotony was observed in 9.4 %, 4.7 %, 6.4 % and 21.9 %, respectively. The authors concluded that although there was no significant improvement in VA, re-detachment and complication rates were comparable to other studies. The duration of endo-tamponade was not significantly associated with the re-detachment rate.
In a retrospective, chart review, Hocaoglu et al (2019) examined the outcomes of retinal detachment in eyes with chorio-retinal coloboma managed by PPV and silicone oil tamponade. This study included 10 eyes (10 patients) who underwent PPV for retinal detachment with chorio-retinal coloboma. The average age at the time of the surgery was 29.8 ± 19.7 years. The mean follow-up period was 28.8 ± 28.4 months. The mean silicone oil tamponade duration was 9.8 ± 3.5 weeks. Of 10 eyes, 4 (40 %) had retinal breaks outside the coloboma, 4 (40 %) had breaks inside the coloboma, 1 (10 %) had breaks inside and outside the coloboma, and in 1 eye (10 %); the causative retinal break was not localized. Pre-operatively, the mean VA was 20/2,500 (n = 9), and 1 (10 %) was recorded as "Not CSM". At the final examination, the mean VA for the patients with measurable VA was 20/200 (p = 0.06), and in the remaining eye was recorded as light perception. The retina was finally re-attached in 9 eyes (90 %). Post-operative complications included cataract in 3 (30 %), persistent elevated intra-ocular pressure (IOP) in 1 (10 %), band keratopathy in 1 (10 %), and proliferative vitreoretinopathy in 1 (10 %). The authors concluded that complete PPV with or without lensectomy, laser photocoagulation around the peripheral retina, around all the peripheral breaks and around the colobomatous area, and silicone oil tamponade was effective for retinal detachment in eyes with chorioretinal coloboma. Silicone oil removal as early as possible did not increase the risk of re-detachment and appeared to reduce the incidence of oil-related complications in such cases.
Fu et al (2022) noted that the recurrence of RD following rhegmatogenous RD (RRD) is a relatively common complication that could result in reduced VA and require further surgery. In a retrospective follow-up study, these investigators examined the risk factors and visual outcomes of recurrent RRD following PPV with SO tamponade for primary the treatment of RRD. This trial included 343 eyes that underwent initial PPV surgery with SO tamponade for primary RRD. Participants were divided into a recurrence group and a re-attachment group. The main outcome measures included causative factors, visual outcomes related to the recurrence of RRD, and the peri-operative factors most affecting the recurrence of RRD. After retinal re-attachment, these researchers observed RRD recurrence following PPV for primary RRD in 42 out of 343 eyes (12.2 %) during the follow-up period. Most causes of recurrence (69 %) occurred within 6 months of surgery. Multi-variate logistic regression analysis showed that a proliferative vitreoretinopathy (PVR) of Grade C or higher (OR: 4.015; 95 % CI: 1.721 to 9.367; p = 0.001) was a significant predictor for the development of recurrent RRD. Compared with the re-attachment group, the recurrence group exhibited a significant decline in BCVA at the last follow-up visit (p = 0.000). Eyes with PVR before primary surgery, or at the diagnosis of re-detachment, showed a worse final BCVA. The authors concluded that this analysis showed that the predominant risk factor for the recurrence of RRD was a PVR of Grade C or higher. In addition, PVR before primary surgery, or at the diagnosis of re-detachment, was also shown to limit the recovery of final VA.
Furthermore, an UpToDate review on “Retinal detachment” (Dahrouj and Gong, 2024) states that “There are three main methods of repairing retinal detachments: pneumatic retinopexy, scleral buckle, and pars plana vitrectomy (PPV) … PPV is an internal, intraocular surgery, with three primary goals: (1) remove the traction around the retinal breaks, (2) tamponade the retinal breaks, and (3) seal the retinal breaks with laser retinopexy or cryoretinopexy … Vitrectomy leads to successful retinal reattachment in approximately 80 to 90 % of patients with RRD. However, virtually all patients over age 50 treated with vitrectomy will develop a visually significant cataract within 6 to 18 months … Following pars plana vitrectomy or pneumatic retinopexy, (when gas is placed in the eye), the patient is required to be in a specific position usually for the first week (such as facedown position) with the goal of sealing the retina break and decreasing the chance of cataract progression. Most of the time, positioning is not required for a primary scleral buckle procedure … The most common tamponade agents are gas including sulfur hexafluoride (SF6), perfluoropropane (C3F8), or silicone oil (SO) … In situations where variation in altitude is inevitable, or when a patient needs to fly after surgery, using silicone oil as tamponade is helpful, but this will require a second surgery to remove the silicone oil”.
References
The above policy is based on the following references:
- American Academy of Ophthalmology (AAO). Diabetic retinopathy. Preferred Practice Pattern. San Francisco, CA: AAO; October 2014.
- American Academy of Ophthalmology (AAO). Idiopathic epiretinal membrane and vitreomacular traction. Preferred Practice Pattern. San Francisco, CA: AAO; 2019.
- Cao K, Wang J, Zhang J, et al. Efficacy and safety of vitrectomy for congenital cataract surgery: A systematic review and meta-analysis based on randomized and controlled trials. Acta Ophthalmol. 2019;97(3):233-239.
- Carbonell D, Mahajan S, Chee S-P, et al; Study Group for Vitreoretinal Lymphoma Diagnostics. Consensus recommendations for the diagnosis of vitreoretinal lymphoma. Ocul Immunol Inflamm. 2021;29(3):507-520.
- Centers for Medicare & Medicaid Services (CMS). National Coverage Determination for Vitrectomy (80.11). Baltimore, MD: CMS: June 19, 2006.
- Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124-136.
- Dahrouj M, Gong DA. Retinal detachment. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed May 2024.
- Daud F, Daud K, Popovic MM, et al. Combined versus sequential pars plana vitrectomy and phacoemulsification for macular hole and epiretinal membrane: A systematic review and meta-analysis. Ophthalmol Retina. 2023;7(8):721-731.
- Do DV, Gichuhi S, Vedula SS, Hawkins BS. Surgery for post-vitrectomy cataract. Cochrane Database Syst Rev. 2013;12:CD006366.
- Dysager DD, Koren SF, Grauslund J, et al. Efficacy and safety of pars plana vitrectomy for primary symptomatic floaters: A systematic review with meta-analyses. Ophthalmol Ther. 2022;11(6):2225-2242.
- Ehrlich R, Polkinghorne P. Small-gauge vitrectomy in traumatic retinal detachment. Clin Experiment Ophthalmol. 2011;39(5):429-433.
- El-Sabagh HA, Abdelghaffar W, Labib AM, et al. Preoperative intravitreal bevacizumab use as an adjuvant to diabetic vitrectomy: Histopathologic findings and clinical implications. Ophthalmology. 2011;118(4):636-641.
- Eshtiaghi A, Dhoot AS, Mihalache A, et al. Pars plana vitrectomy with and without supplemental scleral buckle for the repair of rhegmatogenous retinal detachment: A meta-analysis. Ophthalmol Retina. 2022;6(10):871-885.
- Fallico M, Russo A, Longo A, et al. Internal limiting membrane peeling versus no peeling during primary vitrectomy for rhegmatogenous retinal detachment: A systematic review and meta-analysis. PLoS One. 2018;13(7):e0201010.
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