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

Trials
Jean-Baptiste DucloyerMichel Weber

Abstract

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. 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...Continue Reading

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Citations

Dec 22, 2020·Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft·UNKNOWN Berufsverband der Augenärzte Deutschlands e. V. (BVA)UNKNOWN Retinologische Gesellschaft e. V. (RG)

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Methods Mentioned

BETA
contraception
dissection

Clinical Trials Mentioned

NCT02146144

Software Mentioned

PEELING

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