Human Amniotic Membrane Plug for Large Macular Holes

Not Applicable

Completed

• Conditions: Macular Holes
• Interventions: Procedure: human amniotic membrane plug with vitrectomy

• Registration Number: NCT03917602
• Lead Sponsor: University of Alexandria

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-14
• Study First Posted: 2019-04-17
• Study Start: 2019-05-11
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with large macular holes	human amniotic membrane plug with vitrectomy	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.

Primary Outcome Measures

Name	Time	Method
closure of the macular hole	at the 6 month follow up visit	closure of the macular hole as shown by optical coherence tomography

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt