Human Amniotic Membrane Plug for Large Macular Holes

Study Overview
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Brief Summary
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This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.

Detailed Description
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This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes. Included participants with large macular holes will undergo complete vitrectomy is performed with an accurate vitreal base shaving (Constellation; Alcon Surgical). A human amniotic membrane hAM plug is taken from the hAM patch, and the final dimensions are adjusted with vitreoretinal scissors before insertion into the vitreous. The hAM plug is rolled inside the vitreoretinal forceps and inserted through the trocar into the vitreous. Then the human amniotic membrane is transplanted through macular hole into the subretinal space; it is then spread to cover the entire portion of the hole. Afterward, perfluorocarbon is injected to a complete overfilling of the break to permit good adhesion of the hAM plug to the underlying RPE and the overlying retina. Fluid-air exchange and an endotamponade injection is performed at the end of surgery.

Official Title
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Human Amniotic Membrane Plug for Large Macular Holes

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: human amniotic membrane plug with vitrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: large macular hole confirmed by optical coherence tomography Exclusion Criteria: patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy

Ages Eligible for Study
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Minimum Age: 5 Years

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with large macular holes<br>Patients suffering from large macular holes as documented by spectral domain OCT will undergo pars plan vitrectomy with human amniotic membrane insertion into the macular hole. | Procedure: human amniotic membrane plug with vitrectomy<br>* using human amniotic membrane plug with vitrectomy to try to close large macular hole<br>* Other names: human amniotic membrane plug with vitrectomy for closure of large macular holes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| closure of the macular hole | closure of the macular hole as shown by optical coherence tomography | at the 6 month follow up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human amniotic membrane; large macular holes