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

NCT02146144 | Completed DMC

• 1 other identifier: RC14_0026
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Idiopathic epimacular membrane; internal limiting membrane peeling; microscotomas

Outcome Measures

Primary Outcomes (1)

• the difference in microscotomas between the inclusion visit and the visit at 6 months after surgery.

  Analysis of the primary endpoint: the main criterion is the difference between the number of microscotomas measured before surgery and the number of microscotomas measured at 6 months (number between 0 and 29). The mean difference will be calculated in each of two groups and compared using a mixed model of linear regression to take into account the stratification of the randomization at the center (the center will be considered as a random effect)

  6 months

Secondary Outcomes (2)

• Study of anatomical and functional changes of the retina

  12 months

• Study the rate of EMM recurrence (at M12) between the 2 groups.

  12 months

Study Arms (2)

no peeling

NO INTERVENTION

where the ILM peeling will not be made

active peeling

ACTIVE COMPARATOR

where the ILM peeling will be made

Procedure: ILM Peeling

Interventions

ILM Peeling PROCEDURE

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

active peeling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years old) and female without childbearing potential or active contraception (intra-uterine device, contraceptive pill or contraceptive implant).
• Patients with an idiopathic symptomatic epimacular membrane; for patients with both eyes affected, the eye treated in the protocol will be the one which is most severely affected.
• Pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts
• Patients with social security
• Patients able to understand and follow the trial instructions
• Patients who have signed an informed consent

You may not qualify if:

• Patient with other retinal pathologies such as age related macular degeneration ("AMD"), retinal vein occlusion, diabetic retinopathy, glaucoma with macular visual field defect
• Patients with uveitis or history of uveitis
• Patients with any recent eye injuries or eye surgeries (\<6 months)
• Patients participating in interventional clinical trial
• Pregnant or breast feeding women
• Vulnerable people : persons deprived of liberty; under trusteeship or under curatorship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

CHU de Dijon

Dijon, France

Location

Clinique Sourdille

Nantes, 44000, France

Location

CHU de Nantes

Nantes, France

Location

Fondation Ophtalmologique A. de Rothschild

Paris, France

Location

Hôpital Lariboisière (AP-HP)

Paris, France

Location

Polyclinique de l'atlantique

Saint-Herblain, 44800, France

Location

Related Publications (2)

• Ducloyer JB, Eude Y, Volteau C, Lebreton O, Bonissent A, Fossum P, Tadayoni R, Creuzot-Garcher CP, Le Mer Y, Perol J, Fortin J, Jobert A, Billaud F, Ivan C, Poinas A, Weber M; CFSR Research Net. Pros and cons of internal limiting membrane peeling during epiretinal membrane surgery: a randomised clinical trial with microperimetry (PEELING). Br J Ophthalmol. 2024 Dec 17;109(1):119-125. doi: 10.1136/bjo-2023-324990.

  PMID: 38901960 DERIVED

• Ducloyer JB, Ivan J, Poinas A, Lebreton O, Bonissent A, Fossum P, Volteau C, Tadayoni R, Creuzot-Garchet C, Le Mer Y, Perol J, Fortin J, Chiffoleau A, Billaud F, Ivan C, Weber M. Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial. Trials. 2020 Jun 8;21(1):500. doi: 10.1186/s13063-020-04433-9.

  PMID: 32513229 DERIVED

Study Officials

• Ramin Tadayoni, Pr

  Hôpital Lariboisière, AP-HP

  PRINCIPAL INVESTIGATOR

• Catherine Creuzot-Garchet, Pr

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

• Yannick Le Mer, Pr

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: May 23, 2014
• Study Start: September 9, 2014
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

FR (6)