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Human Amniotic Membrane Plug for Large Macular Holes

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ClinicalTrials.gov Identifier: NCT03917602
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Abouhussein, University of Alexandria

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macular Holes Procedure: human amniotic membrane plug with vitrectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Amniotic Membrane Plug for Large Macular Holes
Actual Study Start Date : May 11, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 31, 2020
Arms and Interventions
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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 Name: human amniotic membrane plug with vitrectomy for closure of large macular holes


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917602


Locations
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Egypt
Alexandria university
Alexandria, Egypt
Sponsors and Collaborators
University of Alexandria
More Information
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Responsible Party: Mahmoud Abouhussein, Assistant professor, University of Alexandria
ClinicalTrials.gov Identifier: NCT03917602    
Other Study ID Numbers: 12042019
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: optical coherence tomography data of patients pre and postoperatively may be shared with other researchers
Supporting Materials: Study Protocol
Time Frame: after start of recruiting patients

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Abouhussein, University of Alexandria:
Human amniotic membrane; large macular holes
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases