Human Amniotic Membrane Plug for Large Macular Holes

March 23, 2020 updated by: Mahmoud Abouhussein, University of Alexandria
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with large macular holes
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
using human amniotic membrane plug with vitrectomy to try to close large macular hole
Other Names:
  • human amniotic membrane plug with vitrectomy for closure of large macular holes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

April 14, 2019

First Submitted That Met QC Criteria

April 14, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12042019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

optical coherence tomography data of patients pre and postoperatively may be shared with other researchers

IPD Sharing Time Frame

after start of recruiting patients

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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