Prospective, Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery (Peeling)

Summary

The epimacular membrane (EMM) is a degenerative condition associated with age, with a variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed by a peeling of the epimacular membrane using a microgripper. Peeling of the internal limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is expected to increase the success rate of EMM surgery by reducing the risk of recurrence of EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is not totally without consequence, it involves the risk of histological disorganization of the retina at the origin of one or several microscotomas, which are themselves responsible for a final visual discomfort. These microscotomas, resulting in the perception of somewhat black spots visible near the fixed point or the fixed image, may be highlighted by microperimetry and would be a loss of functional opportunity for the patient.

In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not alter the vision in half the patients. Furthermore, for those patients who are functionally affected by any such recurrence, a second epimacular membrane peeling surgery can be done.

The main objective of this study is to compare the difference in microscotoma(s) before surgery and 6 months later, between an "active ILM peeling" group and a "no ILM peeling" group. Given the more invasive nature of ILM peeling, the investigators believe that the rate of microscotomas in these patients is higher than those without peeling.

Conditions

• Idiopathic Epimacular Membrane

Interventions

PROCEDURE

ILM Peeling

common surgical procedure: For phakic eyes with cataract • phacoemulsification and implantation of a posterior chamber intraocular lens For all patients: * Central and peripheral 25 Gauge vitrectomy * dissection of the epimacular membrane * injection of Membraneblue-Dual® according to protocol, wait of 1 minute with the infusion line closed, and then suction of surplus and washing of the vitreous cavity * Intraoperative picture to see the possible spontaneous ILM peeling * If no spontaneous ILM peeling, the patient will be randomized at the operating block Specific surgical procedure: • • Randomization into two groups: * Arm 1: "no peeling", where the ILM peeling will not be made * Arm 2: "active peeling", where the ILM peeling will be made

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Ramin Tadayoni, Pr · Hôpital Lariboisière, AP-HP

• Catherine Creuzot-Garchet, Pr · Centre Hospitalier Universitaire Dijon

• Yannick Le Mer, Pr · Fondation Ophtalmologique A. de Rothschild

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-09

Primary Completion

2022-03-14

Completion

2022-03-14

Countries

• France

Study Locations