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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.

SUBMITTER: Ducloyer JB

PROVIDER: S-EPMC7278143 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial.

Ducloyer Jean-Baptiste JB Ivan Juliette J Poinas Alexandra A Lebreton Olivier O Bonissent Alexandre A Fossum Paul P Volteau Christelle C Tadayoni Ramin R Creuzot-Garchet Catherine C Le Mer Yannick Y Perol Julien J Fortin June J Chiffoleau Anne A Billaud Fanny F Ivan Catherine C Weber Michel M

Trials 20200608 1

<h4>Background</h4>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 ...[more]

PMID: 32513229

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Project description:BackgroundAlthough previously published meta-analyses have compared the surgical effects between the methods of Idiopathic epiretinal membrane (iERM) removal with or without ILM peeling, they did not reach an agreement.PurposeWe aimed to provide more evidence for the treatment of iERM and whether additional ILM peeling was better or not by analyzing more updated studies and randomized control trials (RCTs).MethodThe search was conducted in Pubmed, Embase, Cochrane Library, Web of Science and Open Grey without language limitation and the studies included were from inception to December 2019. All studies of iERM with or without ILM peeling showed at least one of outcomes, such as best-corrected visual acuity (BCVA), central macular thickness (CMT) and recurrence of ERM. The pooled results between above groups were showed by the mean differences (MDs) and risk ratios (RR) with corresponding 95% confidence intervals (CIs).ResultIn total, 1645 eyes of five randomized controlled trials (RCTs) and fifteen retrospective studies were included. The short-term (<12 months) BCVA improvement in both groups showed no significant difference (MD = -0.01; 95% CI = -0.02 to 0.01; P = 0.36). However, the BCVA improvement was significantly better in ILM peeling eyes than in those without ILM peeling when considering the risk bias (MD = -0.04; 95% CI = -0.07 to -0.01; P = 0.008). The short-term (<12 months) CMT had a higher reduction in non ILM peeling group (MD = -9.02; 95% CI = -12.51 to -5.54; P < 0.00001) and the recurrence of ERM in ILM peeling group was lower (P < 0.00001). The long-term (≥12months) BCVA improvement ((MD = -0.00; 95% CI = -0.03 to 0.03; P = 0.97) and reduction of long-term (≥12months) CMT (MD = -1.14; 95% CI = -7.14 to -4.86; P = 0.71) were similar in both groups.ConclusionBy considering the risk of bias, we should determine whether ILM peeling is beneficial for short-term changes in BCVA in patients with iERM. Nevertheless, further studies are needed to confirm this. iERM removal without ILM peeling can improve the short-term decrease in CMT and ILM peeling decreases the recurrence of ERM, but the long-term changes in BCVA and CMT are similar with or without ILM peeling. There is a need for a true large scale randomized trial that will also include microperimetry and other functional measures.

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:To investigate visual field changes after vitrectomy for macular diseases in glaucomatous eyes.A retrospective review of 54 eyes from 54 patients with glaucoma, who underwent vitrectomy for epiretinal membrane (ERM; 42 eyes) or macular hole (MH; 12 eyes). Standard automated perimetry (Humphrey visual field 24-2 program) was performed and analyzed preoperatively and twice postoperatively (1st and 2nd sessions; 4.7 ± 2.5, 10.3 ± 3.7 months after surgery, respectively). Postoperative visual field sensitivity at each test point was compared with the preoperative value. Longitudinal changes in mean visual field sensitivity (MVFS) of the 12 test points within 10° eccentricity (center) and the remaining test points (periphery), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and ganglion cell complex (GCC) thickness, and the association of factors with changes in central or peripheral MVFS over time were analyzed using linear mixed-effects models. In addition, 45 eyes from 45 patients without glaucoma who underwent vitrectomy for epiretinal membrane (ERM; 34 eyes) or macular hole (MH; 11 eyes) were similarly examined and statistically analyzed (control group).In glaucomatous eyes, visual field test points changed significantly and reproducibly; two points deteriorated only at the center and twelve points improved only at the periphery. Central MVFS decreased (p = 0.03), whereas peripheral MVFS increased postoperatively (p = 0.010). In the control group, no visual field test points showed deterioration, and central MVFS did not change significantly after vitrectomy. BCVA improved, GCC thickness decreased, and IOP did not change postoperatively in both groups. The linear mixed-effects models identified older age, systemic hypertension, longer axial length, and preoperative medication scores of ?2 as risk factors for central MVFS deterioration in glaucomatous eyes.Visual field sensitivity within 10° eccentricity may deteriorate after vitrectomy for ERM or MH in glaucomatous eyes.

Project description:BackgroundA 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/designPatients 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.DiscussionFILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.

Dataset Information

Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial.

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Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial.

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