Amniotic Membrane for Recurrent Macular Hole

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03528122
• Other study ID #: 63 2/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2020
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Macula Hole
• Macular Degeneration
• Myopic Macular Degeneration
• Retinal Detachment
• Retinal Perforations

Intervention

Procedure:
• Recurrent opened macular hole
pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade

Locations

Country	Name	City	State
Egypt	Minia UNiversity hospital	Minya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical restoration of macular hole closure	Closure of the macular hole	6 months
Secondary	Functional restoration after closure of the macular hole	Improvement of the best corrected visual acuity (BCVA)	6 months
Secondary	Functional restoration after closure of the macular hole	Any improvement of the waves in the electrophysiological (ERG) study.	6 months