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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery
Hôpital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France
Closure of recurrent macular hole
Macular hole closure evaluated by optical coherence tomography (OCT)
Time frame: 6 months
Absence of adverse reaction
Analysis of all adverse events and comparison with adverse events observed after vitrectomy
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Functional restoration after closure of the macular hole
Best corrected visual acuity (BCVA) and microperimetry assessment
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
Anatomical restoration
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
Time frame: 1 month, 3 months, 6 months
Evaluation of the surgical technique of placing the membrane
Duration of coverage by Visio-AMTRIX and persistent after gas removal
Time frame: 7 days, 15 days, 1 month, 3 months, 6 months
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