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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03917602
Other study ID # 12042019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2019
Est. completion date January 31, 2020

Study information

Verified date March 2020
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
human amniotic membrane plug with vitrectomy
using human amniotic membrane plug with vitrectomy to try to close large macular hole

Locations

Country Name City State
Egypt Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary closure of the macular hole closure of the macular hole as shown by optical coherence tomography at the 6 month follow up visit
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