Macular Holes, Retinal Detachment
Conditions
Brief 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.
Interventions
BIOLOGICALVisio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery
Sponsors
TBF Genie Tissulaire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure of recurrent macular hole | 6 months | Macular hole closure evaluated by optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of adverse reaction | 7 days, 15 days, 1 month, 3 months, 6 months | Analysis of all adverse events and comparison with adverse events observed after vitrectomy |
| Functional restoration after closure of the macular hole | 7 days, 15 days, 1 month, 3 months, 6 months | Best corrected visual acuity (BCVA) and microperimetry assessment |
| Anatomical restoration | 1 month, 3 months, 6 months | Anatomical restoration of the outer segments (external limiting membrane and ellipsoid layer). Anatomical changes in the ganglion cell layer of the retina in the area around the hole and under the membrane. The assessment is done by OCT measuring the thickness of the ganglion cell layer |
| Evaluation of the surgical technique of placing the membrane | 7 days, 15 days, 1 month, 3 months, 6 months | Duration of coverage by Visio-AMTRIX and persistent after gas removal |
Countries
France
Outcome results
None listed