Prospective, Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery (Peeling) (Peeling)
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|ClinicalTrials.gov Identifier: NCT02146144|
Recruitment Status : Recruiting
First Posted : May 23, 2014
Last Update Posted : November 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Epimacular Membrane||Procedure: ILM Peeling||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
No Intervention: no peeling
where the ILM peeling will not be made
Active Comparator: active peeling
where the ILM peeling will be made
Procedure: ILM Peeling
common surgical procedure:
For phakic eyes with cataract • phacoemulsification and implantation of a posterior chamber intraocular lens
For all patients:
Specific surgical procedure:
• • Randomization into two groups:
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146144
|Contact: Michel Pr Weber, Prfirstname.lastname@example.org|
|CHU de Dijon||Recruiting|
|Contact: Catherine Creuzot-Garchet, Profesor|
|Clinique Sourdille||Not yet recruiting|
|Nantes, France, 44000|
|Contact: Becquet Franck|
|CHU de Nantes||Recruiting|
|Contact: Michel Weber, Profesor|
|Fondation Ophtalmologique A. de Rothschild||Recruiting|
|Contact: Yannick Le Mer, Profesor|
|Hôpital Lariboisière (AP-HP)||Recruiting|
|Contact: Ramin Tadayoni, Profesor|
|Polyclinique de l'atlantique||Not yet recruiting|
|Saint-Herblain, France, 44800|
|Contact: Lignereux François|
|Principal Investigator:||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|