Amniotic Membrane for Recurrent Macular Hole

Not Applicable

• Conditions: Myopic Macular Degeneration; Macula Hole; Retinal Detachment
• Interventions: Procedure: Recurrent opened macular hole

• Registration Number: NCT03528122
• Lead Sponsor: Minia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-05-05
• Study First Posted: 2018-05-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recurrent opened macular hole	Recurrent opened macular hole	Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft

Primary Outcome Measures

Name	Time	Method
Anatomical restoration of macular hole closure	6 months	Closure of the macular hole

Secondary Outcome Measures

Name	Time	Method
Functional restoration after closure of the macular hole	6 months	Any improvement of the waves in the electrophysiological (ERG) study.

Trial Locations

Locations (1)

Minia UNiversity hospital; 🇪🇬 Minya, Minia, Egypt