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

Launched by NANTES UNIVERSITY HOSPITAL · May 22, 2014

Keywords

ClinConnect Summary

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), micr...

Gender

ALL

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