Amniotic Membrane for Recurrent Macular Hole

Study Overview
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Brief Summary
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Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.

Detailed Description
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It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.

Official Title
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The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole

Conditions
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Macula Hole, Retinal Detachment, Myopic Macular Degeneration

Intervention / Treatment
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* Procedure: Recurrent opened macular hole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included. Opened holes after 1 month of the surgery. Myopic macular holes only were included (Refraction of more than _6 D and/or axial length of more than 26 mm). Exclusion Criteria: All other causes of macular hole (traumatic and idiopathic) Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Individuals with recurrent macular hole associated retinal detachment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recurrent opened macular hole<br>Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft | Procedure: Recurrent opened macular hole<br>* pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical restoration of macular hole closure | Closure of the macular hole | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional restoration after closure of the macular hole | Improvement of the best corrected visual acuity (BCVA) | 6 months | 
| Functional restoration after closure of the macular hole | Any improvement of the waves in the electrophysiological (ERG) study. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amniotic membrane, retinal detachment, Myopic, macular hole, internal limiting membrane