Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole
Stopped: Low accrual rate
France12 participantsStarted 2020-06-10
Plain-language summary
The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Man or woman over 18 years of age, less than 75 years
* Macular Hole of all etiologies
* Patient with history of opened macular hole after previous pars plana vitrectomy
* Delay between previous surgery and inclusion (relapse or non-closing hole) \> 1 month
* Patient who received the study information and provided consent
* Patient who is a members or a beneficiary of a national health insurance plan
Exclusion Criteria:
* Ocular surgery other than the macular hole surgery in the prior 3 months
* Participation in other clinical studies in the prior 3 months
* Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
* Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
* Patient with uveitis or other active ocular inflammation or infection
* Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
* Person deprived of liberty by judicial or administrative measures
* Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study