Completed

NCT Number: NCT02146144

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

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.

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Key information

Conditions

Idiopathic Epimacular Membrane

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon, Dijon, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 6 months

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)

Secondary outcomes

Study of anatomical and functional changes of the retina

Time frame: 12 months

Number and types of microscotomas by microperimetry (before and after surgery)
Study the rate of EMM recurrence (at M12) between the 2 groups.

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: Peeling

Important dates

Study start: 2014
Primary completion: 2022
Study completion: 2022
First posted: May 23, 2014
Registry last updated: Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.