Prospective, Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery (Peeling) (Peeling)
Primary Purpose
Idiopathic Epimacular Membrane
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ILM Peeling
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Epimacular Membrane focused on measuring Idiopathic epimacular membrane, internal limiting membrane peeling, microscotomas
Eligibility Criteria
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
Sites / Locations
- CHU de Dijon
- Clinique Sourdille
- CHU de Nantes
- Fondation Ophtalmologique A. de Rothschild
- Hôpital Lariboisière (AP-HP)
- Polyclinique de l'atlantique
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
no peeling
active peeling
Arm Description
where the ILM peeling will not be made
where the ILM peeling will be made
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Study of anatomical and functional changes of the retina
Number and types of microscotomas by microperimetry (before and after surgery)
Study the rate of EMM recurrence (at M12) between the 2 groups.
Full Information
NCT ID
NCT02146144
First Posted
April 7, 2014
Last Updated
February 9, 2023
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02146144
Brief Title
Prospective, Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery (Peeling)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2014 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Epimacular Membrane
Keywords
Idiopathic epimacular membrane, internal limiting membrane peeling, microscotomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no peeling
Arm Type
No Intervention
Arm Description
where the ILM peeling will not be made
Arm Title
active peeling
Arm Type
Active Comparator
Arm Description
where the ILM peeling will be made
Intervention Type
Procedure
Intervention Name(s)
ILM Peeling
Intervention Description
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 Outcome Measure Information:
Title
the difference in microscotomas between the inclusion visit and the visit at 6 months after surgery.
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Study of anatomical and functional changes of the retina
Description
Number and types of microscotomas by microperimetry (before and after surgery)
Time Frame
12 months
Title
Study the rate of EMM recurrence (at M12) between the 2 groups.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramin Tadayoni, Pr
Organizational Affiliation
Hôpital Lariboisière, AP-HP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Creuzot-Garchet, Pr
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yannick Le Mer, Pr
Organizational Affiliation
Fondation Ophtalmologique A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
Clinique Sourdille
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
Fondation Ophtalmologique A. de Rothschild
City
Paris
Country
France
Facility Name
Hôpital Lariboisière (AP-HP)
City
Paris
Country
France
Facility Name
Polyclinique de l'atlantique
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32513229
Citation
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.
Results Reference
derived
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Prospective, Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery (Peeling)
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