Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial.
ABSTRACT: BACKGROUND:The epiretinal membrane (ERM) is a degenerative condition associated with age, which can cause loss of vision and/or metamorphopsia. The treatment of symptomatic ERM involves surgical removal including a vitrectomy followed by peeling of the ERM using a microforceps. As the internal limiting membrane (ILM) is adherent to the ERM, it is sometimes removed with it (spontaneous peeling). If ILM remains in place, it can be removed to reduce ERM recurrence. However, it is important to clarify the safety of ILM peeling, while it increases surgical risks and cause histological disorganization of the retina that can lead to microscotomas, may be responsible for definitive visual discomfort. METHODS:PEELING is a prospective, randomized, controlled, single-blind, and multicentered trial with two parallel arms. This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling. Randomization is done in the operating room after ERM removal if ILM remains in place. After randomization, the two groups-"active peeling of the ILM" and "no peeling of the ILM"-are compared during a total of three follow-up visits scheduled at month 1, month 6, and month 12. Primary endpoint is the difference in microscotomas before surgery and 6?months after surgery. Patients with spontaneous peeling are not randomized and are included in the ancillary study with the same follow-up visits and the same examinations as the principal study. Relevant inclusion criteria involve individuals aged >?18?years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts. The calculated sample size corresponds to 53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling). DISCUSSION:ILM peeling is often practiced in ERM surgery to reduce ERM recurrence. It does not impair postoperative visual acuity, but it increases the surgical risks and causes anatomical damages. If active ILM peeling is significantly associated with more microscotomas, it may contraindicate the ILM peeling during primitive idiopathic ERM surgery. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02146144. Registered on 22 May 2014. Recruitment is still ongoing.
Project description:<h4>Background</h4>Internal limiting membrane (ILM) peeling during primary vitrectomy for rhegmatogenous retinal detachment (RRD) prevents the formation of postoperative macular epiretinal membrane (ERM). However, studies that compared vitrectomy with and without ILM peeling for RRD, have reported controversial outcomes.<h4>Objective</h4>To assess the efficacy of ILM peeling versus non-ILM peeling during vitrectomy for RRD by a systematic review and meta-analysis of published studies.<h4>Methods</h4>PubMed, Medline, Web of Science, Embase databases, and the Cochrane Library were searched up to April 2018 to identify studies that compared primary vitrectomy with and without ILM peeling for RRD with at least six months follow-up. Primary outcomes were the rate of postoperative ERM formation and mean best corrected visual acuity (BCVA) change after vitrectomy. Rate of recurrence of retinal detachment (RD) was assessed as secondary outcome. Risk ratios (RRs) with 95% confidence intervals (CIs) expressed pooled results for rate of ERM formation and rate of RD recurrence in ILM peeling and non-ILM peeling groups. Pooled results for BCVA change in the two groups were expressed as Weighted Mean Difference (WMD) with 95% CIs.<h4>Results</h4>Nine studies, one of which was a randomized controlled trial (RCT), with a total number of 404 eyes in the ILM peeling group and 365 eyes in the non-ILM peeling group, were included. The analysis from pooled data indicated a significant lower rate of postoperative ERM formation in the ILM peeling group compared to the non-ILM peeling group (9 studies, 769 eyes, RR = 0.14; CI: 0.07 to 0.28; P < 0.001). There was no statistical difference in mean BCVA change (9 studies, 769 eyes, WMD = 0.02; CI: -0.11 to 0.16; P = 0.75). Rate of recurrence of RD was lower in the ILM peeling group (6 studies, 603 eyes, RR = 0.32; CI = 0.17 to 0.61; P< 0.001).<h4>Conclusion</h4>ILM peeling during vitrectomy for RRD prevents the formation of macular epiretinal membrane postoperatively and reduces the incidence of RD recurrence, but better visual outcome was not found compared to non-ILM peeling vitrectomy.
Project description:Studies on vitrectomy with and without internal limiting membrane (ILM) peeling for idiopathic epiretinal membrane (ERM) have yielded uncertain results regarding clinical outcomes and recurrence rates.To compare the clinical outcomes of vitrectomy with and without ILM peeling for idiopathic ERM.Databases, including PubMed, Embase, Cochrane, Web of Science, Google Scholar, CNKI databases, FDA.gov, and ClinicalTrials.gov, published until July 2016, were searched to identify studies comparing the clinical outcomes following vitrectomy with ERM and ILM peeling and with only ERM peeling, for treating idiopathic ERM. Studies with sufficient data were selected. Pooled results were expressed as mean differences (MDs) and risk ratios (RRs) with corresponding 95% confidence intervals (CI) for vitrectomy with and without ILM peeling with regard to postoperative best corrected visual acuity (BCVA), central retinal thickness (CRT), and ERM recurrence rate.Eleven retrospective studies and one randomized controlled trial involving 756 eyes were identified. This demonstrated that the postoperative BCVA within 12 months was significantly better in the non-ILM peeling group (MD = 0.04, 95% CI: 0.00 to 0.08; P = 0.0460), but that the patients in the ILM peeling group had significantly better postoperative BCVA after 18 months (MD = -0.13, 95% CI: -0.23 to -0.04; P = 0.0049) than did those in the non-ILM peeling group. The non-ILM peeling group exhibited a higher reduction in postoperative CRT (MD = 51.55, 95% CI:-84.23 to -18.88; P = 0.0020) and a higher recurrence rate of ERM (RR = 0.34, 95% CI:0.16 to 0.72; P = 0.0048) than did the ILM peeling group. However, the improvement rates of BCVA (RR = 1.03, 95% CI:0.72 to 1.47; P = 0.8802) and postoperative CRTs (MD = 18.15, 95% CI:-2.29 to 38.60; P = 0.0818) were similar between the two groups.Vitrectomy with ILM peeling results in better visual improvement in long-term follow-ups and lower ERM recurrence rates, and vitrectomy with only ERM peeling is more efficacious in reduction of CRT than is vitrectomy with ILM peeling.
Project description:PURPOSE:The internal limiting membrane (ILM) is a normal part of the retina, and the outcomes of ILM removal have not been fully investigated. ILM flap inversion is a recently developed technique that increases the success rate of macular hole (MH) surgery. Thus, we compared the anatomical closure rate and visual outcome in patients undergoing microincision vitrectomy surgery (MIVS) with ILM flap inversion or conventional ILM peeling for the treatment of MH. METHODS:The medical records of 90 eyes with MH were reviewed retrospectively. The patients were classified into two groups based on MIVS procedure (group 1: ILM flap inversion, 46 eyes; group 2: ILM peeling, 44 eyes). RESULTS:Preoperative characteristics were similar in the two groups, and there were no significant differences in 1 month- or 6 month-postoperative VA between the groups (P = 0.25 and P = 0.42, respectively). However, the surgical success rate was significantly higher in group 1 than group 2 (P = 0.04; 46/46: 100% and 41/44: 93%, respectively). Multiple regression analysis revealed that axial length and MH diameter were independent factors predicting 6-month postoperative BCVA in group 2 (P = 0.001 and P = 0.03, respectively), and that MH diameter was an independent factor predicting 6-month postoperative VA in group 1 (P = 0.03). Logistic regression analysis revealed that axial length (OR = 2.11; P = 0.02; area under the curve: 0.94; cut off score: 28.4 mm) was an independent factor indicating surgical failure in group 2. CONCLUSION:Our results suggest that MIVS with ILM flap inversion might be best suited to treat MH, particularly in patients with high myopia.
Project description:We describe the utilization of indocyanine green (ICG) dye to facilitate combined/en bloc removal of epiretinal membranes (ERM) along with internal limiting membranes (ILM). The method utilizes a highly diluted preparation of ICG in dextrose water solvent (D5W). Elimination of fluid air exchange step facilitating staining in the fluid phase and low intensity lighting help minimize potential ICG toxicity. The technique demonstrates how ICG facilitates negative staining of ERMs and how ILM peeling concomitantly can allow complete and efficient ERM removal minimizing surgical time and the necessity for dual or sequential staining.
Project description:Purpose:To assess the retinal architecture changes which occur during epiretinal membrane (ERM) surgery, utilizing intraoperative optical coherence tomography (iOCT). Design:Prospective multi-surgeon single center study. Subjects/Participants:Subjects from the PIONEER iOCT study who underwent surgical intervention for management of ERM. Methods:All subjects underwent vitrectomy with ERM peeling with optional internal limiting membrane (ILM) peeling. Preoperative, intraoperative, and postoperative quantitative and qualitative OCT assessments were performed. Clinical characteristics including visual acuity outcomes, central subfield thickness and complications including ERM recurrence and need for reoperation were assessed at 3, 6 and 12 months following surgery for membrane peeling, as available. Main Outcome measures:Visual acuity outcomes, anatomic outcomes and complications including ERM recurrence. Microarchitectural alterations (i.e. retinal layer changes) following membrane peeling visualized with iOCT. Results:Seventy-six were identified and included in this analysis of clinical outcomes and quantitative OCT assessment. Twenty-four eyes were excluded due to insufficient intraoperative OCT quality for quantitative assessment. The mean preoperative VA measured 20/63. The mean postoperative VA at 3 months was 20/41 (p<0.0001), at 6 months measured 20/36 (p < 0.0001), and at 12 months measured 20/33 (p < 0.0001). Preoperative mean central subfield thickness (CST) was 426 microns. At 3 months, the mean CST improved to 377 microns (p < 0.0001). The 6-month postoperative CST was 367 microns (p < 0.0001) and the 12-month postoperative CST measured 359 microns (p < 0.0001). Immediately following membrane peeling, the distance between the retinal pigment epithelium and the ellipsoid zone as well as the distance between the retinal pigment epithelium and the cone outer segment tips/interdigitation zone significantly increased (p < 0.001). iOCT identified occult residual membranes in 12% of cases and confirmed complete membrane peeling contrary to surgeon impression in 9% of cases. Reoperation was required for recurrent ERM in 1% of eyes. Conclusions:iOCT-assisted ERM peeling resulted in significant improvement in visual acuity, reduction in macular thickness, and low recurrence rate. Additional research is needed with randomized clinical trials to better define the comparative success rates of image-guided ERM surgery to standard surgical visualization techniques.
Project description:Background:Epiretinal membranes (ERMs) have been reported after pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD). Peeling of the internal limiting membrane (ILM) can prevent post-PPV ERM formation but has a potential negative impact on macular structure and function. Purpose:To investigate the anatomical and functional outcomes of ILM peeling during PPV for primary RRD. Methods:This was a prospective nonrandomized study that included 60 eyes of 60 patients with a primary macula-off RRD and less than grade C proliferative vitreoretinopathy (PVR). Eyes were allocated into 2 groups; Group A underwent PPV without ILM peeling and Group B had ILM peeling. At postoperative month 6, all patients underwent retinal imaging using spectral domain optical coherence tomography (OCT) and OCT angiography and macular function was assessed using multifocal electroretinogram (mfERG). Baseline characteristics and postoperative anatomical and visual outcomes were recorded and statistically analyzed. Results:We enrolled 30 eyes of 30 patients in each group. In Group A, mean age was 44.6 years, while the mean age of Group B patients was 49.9 years. Postoperative LogMAR visual acuity was significantly better in Group A than in Group B (p?<?0.001). ERMs were demonstrated on OCT in 13.3% of Group A and none of Group B patients (p?=?0.04). Retinal dimples were found in 53.3% of Group B and none of Group A eyes (p?<?0.001). OCTA showed a greater vessel density of the superficial capillary plexus (SCP) in Group A compared to Group B eyes (p?=?0.046), while no difference was found regarding deep capillary vessel density (p?=?0.7). Mean amplitude of mfERG P1 wave was significantly higher in Group A eyes than in Group B (p?=?0.002). Both the SCP vessel density and P1 amplitude were positively correlated with visual acuity (p?<?0.001). Conclusion:This study suggests that ILM peeling prevents ERM development in eyes undergoing PPV for uncomplicated macula-off RRD, but potential damage to macular structure and function were found.Trial registration Retrospectively registered on 09/24/2019 on ClinicalTrials.gov with an ID of NCT04139811.
Project description:PURPOSE: To evaluate the functional and morphological outcomes of postoperative systemic steroid therapy after successful macular surgery in eyes with macular edema due to idiopathic macular epiretinal membranes (ERMs). DESIGN: Prospective, randomized, investigator-masked, controlled clinical study. METHODS: Twenty-eight patients scheduled for 23-gauge vitrectomy combined with ERM and inner limiting membrane (ILM) peeling for macular edema due to ERM were included in this single center trial. Patients were randomized to receive oral steroid therapy (Prednisolone, 100 mg per day for 5 days) or no oral steroid (control group) after surgery. Main outcome measures included best corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study), central retinal thickness (CRT), retinal volume (RV), and macular morphology as determined by spectral domain optical coherence tomography (SD-OCT, Cirrus). Examinations were carried out preoperatively and at week 1, at months 1 and 3, postoperatively. RESULTS: At month 3, mean BCVA improved to a eight-letter gain in each study group (P<0.01 compared with baseline for both groups), showing no statistically significant difference between both the groups (P=0.19). Morphologically, retinal surface folds resolved within 1 month after surgery in both treatment groups, followed by a progressive recovery of retinal layer integrity and a statistical significant (P<0.01) decrease in CRT and RV without significant differences between both groups (P=0.62, P=0.13, respectively, ANOVA between the groups). CONCLUSION: The early postoperative use of systemic steroid treatment after successful vitrectomy combined with ERM and ILM peeling does not seem to improve significantly the anatomic and functional outcomes in eyes with ERM.
Project description:The present study was performed to establish a novel ocular surgery simulator for training in peeling of the inner limited membrane (ILM). This simulator included a next-generation artificial ILM with mechanical properties similar to the natural ILM that could be peeled underwater in the same manner as in actual surgery. An artificial eye consisting of a fundus and eyeball parts was fabricated. The artificial eye was installed in the eye surgery simulator. The fundus part was mounted in the eyeball, which consisted of an artificial sclera, retina, and ILM. To measure the thickness of the fabricated ILM on the artificial retina, we calculated the distance of the step height as the thickness of the artificial ILM. Two experienced ophthalmologists then assessed the fabricated ILM by sensory evaluation. The minimum thickness of the artificial ILM was 1.9 ± 0.3 ?m (n = 3). We were able to perform the peeling task with the ILM in water. Based on the sensory evaluation, an ILM with a minimum thickness and 1000 degrees of polymerization was suitable for training. We installed the eye model on an ocular surgery simulator, which allowed for the performance of a sequence of operations similar to ILM peeling. In conclusion, we developed a novel ocular surgery simulator for ILM peeling. The artificial ILM was peeled underwater in the same manner as in an actual operation.
Project description:BACKGROUND:A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Internal limiting membrane (ILM) peeling has been introduced as an additional surgical manoeuvre to increase the success of the surgery; i.e. increase rates of hole closure and visual improvement. However, little robust evidence exists supporting the superiority of ILM peeling compared with no-peeling techniques. The purpose of FILMS (Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study) is to determine whether ILM peeling improves the visual function, the anatomical closure of FTMH, and the quality of life of patients affected by this disorder, and the cost-effectiveness of the surgery. METHODS/DESIGN:Patients with stage 2-3 idiopathic FTMH of less or equal than 18 months duration (based on symptoms reported by the participant) and with a visual acuity </= 20/40 in the study eye will be enrolled in this FILMS from eight sites across the UK and Ireland. Participants will be randomised to receive combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling. The primary outcome is distance visual acuity at 6 months. Secondary outcomes include distance visual acuity at 3 and 24 months, near visual acuity at 3, 6, and 24 months, contrast sensitivity at 6 months, reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3, 6, and 24 months), health related quality of life (HRQOL) at six months, costs to the health service and the participant, incremental costs per quality adjusted life year (QALY) and adverse events. DISCUSSION:FILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery. TRIAL REGISTRATION:This trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.
Project description:To highlight the differences in macular pigment optical density (MPOD) between eyes with vitreoretinal interface syndrome and healthy control eyes, to assess the changes in MPOD in eyes treated with macular peeling, to investigate the relationships between MPOD changes and measures of retinal sensitivity such as best corrected visual acuity (BCVA) and microperimetry.In this cross-sectional comparative study, 30 eyes affected by idiopathic epiretinal membrane (iERM, 15eyes) or full-thickness macular hole (FTMH, 15eyes) were compared with 60 eyes from 30 healthy age-matched patients. MPOD values (mean MPOD, maximum MPOD, MPOD area, and MPOD volume) were measured in a range of 4°-7° of eccentricity around the fovea, using the one-wavelength reflectometry method (Visucam 200, Carl-Zeiss Meditec). Patients affected by iERM and FTMH were treated with vitrectomy and epiretinal membrane-inner limiting membrane (ERM-ILM) peeling, with follow-up examinations performed preoperatively and 6 months postoperatively. The main outcome measures were the differences in MPOD between eyes with vitreoretinal interface syndrome and healthy eyes, changes in MPOD after ERM-ILM peeling, and relationships between MPOD and functional changes.Mean MPOD differed significantly between control eyes and those with iERM (P = .0001) or FTMH (P = .0006). The max MPOD and MPOD area increased, but not significantly. After peeling, the only significant change in MPOD was in MPOD volume (P = .01). In the ERM group, postoperative mean MPOD correlated significantly with best-corrected visual acuity (r = .739, P = .002).MPOD was reduced in patients with iERM or FTMH compared with healthy eyes. We found a significant correlation between the mean postoperative MPOD and postoperative BCVA, hypothesizing that the postoperative increase in mean MPOD could be due to a change in distribution for unfolding and expansion of the fovea after the peeling. MOPD may be considered as a prognostic factor associated with a good visual prognosis in patients with iERM.