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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01374-53 | Registry Identifier | IDRCB |
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Low accrual rate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visio-AMTRIX | Experimental | Disk of amniotic membrane apposed or buried on recurrent macular hole by the Investigator after vitrectomy and fluid-gas exchange. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visio-AMTRIX | Biological | Chemically-treated, viro-inactivated, freeze-dried and irradiated amniotic membrane placed by the investigator during macular hole surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Closure of recurrent macular hole | Macular hole closure evaluated by optical coherence tomography (OCT) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of adverse reaction | Analysis of all adverse events and comparison with adverse events observed after vitrectomy | 7 days, 15 days, 1 month, 3 months, 6 months |
| Functional restoration after closure of the macular hole |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix-Rousse, Hospices Civils de Lyon | Lyon | 69004 | France |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Best corrected visual acuity (BCVA) and microperimetry assessment
| 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 | 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 | 7 days, 15 days, 1 month, 3 months, 6 months |