The role of internal limiting membrane peeling in epiretinal membrane surgery: a randomised controlled trial

Tranos, Paris; Koukoula, Stavrenia; Charteris, DG; Perganda, Georgia; Vakalis, Athanasios; Asteriadis, Solon; Georgalas, Ilias; Petrou, Petros

doi:10.1136/bjophthalmol-2016-309308

Cited by 33 publications

(35 citation statements)

References 47 publications

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“…There are several studies that compared ERM peeling with ILM peeling and without ILM peeling in the literature. Tranos et al (15) reported that the mean change in distance BCVA at 12 months was 0.30±0.24 logMAR (15 ETDRS letters) in the peeling group and 0.31±0.23 logMAR (14 ET-DRS letters) in the non-peeling group, a change that was not statistically significant (p=0.84). No statistically significant differences were observed when comparing the changes in distance BCVA, changes in metamorphopsia (Amsler grid), and changes in central retinal thickness between the groups at any of the time points.…”

Section: Discussionmentioning

confidence: 95%

Visual And Anatomical Outcomes Following Idiopathic Epiretinal Membrane And Internal Limiting Membrane Peeling

Demir¹

2017

Beyoglu Eye Journal

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The aim of this study was to evaluate the functional and anatomical outcomes and the rate of epiretinal membrane (ERM) recurrence in eyes that had undergone ERM-internal limiting membrane (ILM) peeling surgery at least 6 months earlier. Methods: The records of 81 eyes of 81 patients who underwent pars plana vitrectomy (PPV) and ERM-ILM peeling with the diagnosis of idiopathic ERM between January 2015 and January 2016 in our clinic were retrospectively reviewed. Patients with at least 6 months of follow-up were included. The demographic details of the patients, duration of the followup period, use of endotamponade, and any complications were recorded. Best corrected visual acuity and central macular thickness (CMT) at baseline and at 6, 12, and 18 months were also recorded. Results: A total of 81eyes of 81 patients, 45 (55.6%) males and 36 (44.4%) females, with a group mean age of 65.7±8.5 years (range: 46-85 years) were assessed. The mean preoperative visual acuity was 0.81±0.50 logMAR (the logarithm of the minimum angle of resolution) (0.22 decimals). During the follow-up, the mean visual acuity at 6, 12, and 24 months was 0.61±0.37 logMAR (0.33 decimals), 0.61±0.38 logMAR (0.33 decimals), and 0.55±0.33 logMAR (0.36 decimals), respectively. The visual acuity was significantly better at 6,12, and 24 months compared with the baseline measurement (p<0.05 for all; paired t-test). The mean preoperative CMT was 519±103 μm. During the follow-up, the mean CMT was 302±89 μm, 287±80 μm, and 273±82 μm at 6,12, and 24 months, respectively. Compared with the baseline, a statistically significant difference was observed at 6, 12, and 24 months. Conclusion: PPV with membranectomy and ILM peeling is a safe and effective method to treat idiopathic ERM. It led to a functional improvement and a reduction in macular thickness in most of the patients diagnosed with ERM. The rate of recurrence of ERM and the need for repeat ERM surgery was lower in eyes where the ILM was removed with the ERM than the expected rate for when ERM peeling is performed alone.

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Section: Discussionmentioning

confidence: 95%

Visual And Anatomical Outcomes Following Idiopathic Epiretinal Membrane And Internal Limiting Membrane Peeling

Demir¹

2017

Beyoglu Eye Journal

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“…In a meta-analysis, Azuma et al [7] found a significant reduction of recurrence rate in case of ILM peeling during idiopathic ERM surgery (odds ratio 0.25; 95% CI 0.12-0.49). Two randomized clinical trial compared ILM peeling or not: De Novelli et al found a similar difference after six months (4% of recurrence with ILM peeling and 17% without) but did not reach significance; Tranos et al did not found any recurrence in both group after twelve months [8]. In case of recurrent ERM, vision is impaired in only half of the patients and if visual loss does occur a second ERM surgery is possible [9].…”

Section: Background and Rationale{6a}mentioning

confidence: 99%

“…The peeling of the ILM doesn't alter nor improve post-operative visual acuity [7][8][9][10][11]. This additional procedure lengthens the operation, increases the surgical risks (phototraumatism, retinal tear, central or eccentric macular hole) [12][13][14] and the risk of histological disorganization of the retina [15], which can result in one or more microscotomas with possible definitive visual discomfort for the patients.…”

Section: Background and Rationale{6a}mentioning

confidence: 99%

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

Ducloyer

Ivan

Poinas

et al. 2020

Preprint

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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 maybe responsible for definitive visual discomfort.Methods PEELING is a prospective, randomized, controlled, single-blind and multi-centered trial with two parallel arms. This study investigates the benefit/risk ratio of active ILM peeling among subjects 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 M1, M6 and M12. 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 subjects over 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 (1eye/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 post-operative 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 May 22, 2014. Recruitment is still 4 ongoing Administrative InformationNote: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reportingguidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/). Title {1}: Prospective, randomized, controlled and single-blind study assessing the benefit/risk ratio of internal limiting membrane (ILM) peeling during Epiretinal Membrane (ERM) surgery.

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“…Clark (131) Um estudo prospectivo comparativo randomizado, recentemente publicado (132) , (133) , também não encontrou diferença na acuidade visual final nos pacientes que removeram ou não a MLI. Outros estudos chegaram a mesma conclusão em relação ao ganho visual pós-operatório comparando as duas técnicas (126,(134)(135)(136) .…”

Section: População E Amostraunclassified

“…Quando esta permanece integral ou fragmentada, existe a possibilidade de reproliferação celular, aumentando a chance de recidiva da membrana epirretiniana. Resultado diferente ao presente estudo foi mostrado por Tranos et al (132) , que em estudo comparativo randomizado, em ambos os grupos não aconteceu nenhuma recidiva em seguimento de 12 meses. Os autores acreditam que este resultado, pouco frequente, se comparado à toda literatura, ocorreu pela criteriosa seleção dos pacientes e o uso do corante…”

Section: População E Amostraunclassified

Cirurgia da retirada da membrana epirretiniana com e sem remoção de membrana limitante interna: estudo comparativo da acuidade visual, metamorfopsia, características da tomografia de coerência óptica e taxa de recorrência

Novelli¹

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The role of internal limiting membrane peeling in epiretinal membrane surgery: a randomised controlled trial

Cited by 33 publications

References 47 publications

Visual And Anatomical Outcomes Following Idiopathic Epiretinal Membrane And Internal Limiting Membrane Peeling

Visual And Anatomical Outcomes Following Idiopathic Epiretinal Membrane And Internal Limiting Membrane Peeling

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

Cirurgia da retirada da membrana epirretiniana com e sem remoção de membrana limitante interna: estudo comparativo da acuidade visual, metamorfopsia, características da tomografia de coerência óptica e taxa de recorrência

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