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

Idiopathic Epimacular Membrane Clinical Trial

— Peeling  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146144
• Other study ID #: RC14_0026
• Status: Completed
• Phase: N/A
• Start date: September 9, 2014
• Est. completion date: March 14, 2022

Study information

• Verified date: February 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The visits for this trial are those planned for patients receiving EMM surgical operation, namely:

Selection/Inclusion visit : D-90 to D-7 This visit can be split in two according to the requirements of the investigator and/or the patient.

• Full information about the trial

• Verification of the inclusion and non-inclusion criteria

• Obtaining the signed informed consent (the same day or after a period of reflection)

• Medical and surgical history - *Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), microperimetry and pre-operative: "Patient discomfort" questionnaire (Appendix 7), an assessment of the appearance of the lens at the slit lamp, examination of the fundus after pupillary dilation, biomicroscopic examination of the anterior segment, retinal photography.

Surgery visit D0:

• List of all the surgical procedures

• Randomization for ILM peeling or not, in the operating room after dyeing of the ILM by the Membraneblue-Dual® (Picture of the macula). An anonymous video of the surgery will be sent to Nantes for centralized processing of the analysis of the EMM's grip areas.

To avoid bias, the follow-up visits will be made by an ophthalmologist and/or an orthoptist who will not know what action has been performed.

Follow-up visit M1 (1 month after the surgery ± 7 days)

• Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative "Patient discomfort" questionnaire (Appendix 8). Biomicroscopic examination of the anterior segment, retinal photography.

• AE

Follow-up visit M6 (6 months after the surgery ± 15 days)

• Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative: "Patient discomfort" questionnaire (Appendix 8). Biomicroscopic examination of the anterior segment, retinal photography.

• AE End of study visit M12 (12 months after the surgery ± 15 days)

• Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative "Patient discomfort" questionnaire (Appendix 8), Biomicroscopic examination of the anterior segment, retinal photography.

• AE

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Epiretinal Membrane
• Idiopathic Epimacular Membrane

Intervention

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

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon
France	CHU de Nantes	Nantes
France	Clinique Sourdille	Nantes
France	Fondation Ophtalmologique A. de Rothschild	Paris
France	Hôpital Lariboisière (AP-HP)	Paris
France	Polyclinique de l'atlantique	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study of anatomical and functional changes of the retina	Number and types of microscotomas by microperimetry (before and after surgery)	12 months
Secondary	Study the rate of EMM recurrence (at M12) between the 2 groups.		12 months