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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) (Peeling)

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ClinicalTrials.gov Identifier: NCT02146144
Recruitment Status : Recruiting
First Posted : May 23, 2014
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Idiopathic Epimacular Membrane Procedure: ILM Peeling Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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:

  • 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 Measures :
  1. 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 Outcome Measures :
  1. Study of anatomical and functional changes of the retina [ Time Frame: 12 months ]
    Number and types of microscotomas by microperimetry (before and after surgery)

  2. Study the rate of EMM recurrence (at M12) between the 2 groups. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Michel Pr Weber, Pr 0661180456 michel.weber@chu-nantes.fr

Locations
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France
CHU de Dijon Recruiting
Dijon, France
Contact: Catherine Creuzot-Garchet, Profesor         
Clinique Sourdille Not yet recruiting
Nantes, France, 44000
Contact: Becquet Franck         
CHU de Nantes Recruiting
Nantes, France
Contact: Michel Weber, Profesor         
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France
Contact: Yannick Le Mer, Profesor         
Hôpital Lariboisière (AP-HP) Recruiting
Paris, France
Contact: Ramin Tadayoni, Profesor         
Polyclinique de l'atlantique Not yet recruiting
Saint-Herblain, France, 44800
Contact: Lignereux François         
Contact       françois.ligneureux@free.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02146144    
Other Study ID Numbers: RC14_0026
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Nantes University Hospital:
Idiopathic epimacular membrane
internal limiting membrane peeling
microscotomas