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Amniotic Membrane for Recurrent Macular Hole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03528122
Recruitment Status : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : February 20, 2020
Information provided by (Responsible Party):
Hossam Mohamed Moharram, 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.

Condition or disease Intervention/treatment Phase
Macula Hole Retinal Detachment Myopic Macular Degeneration Procedure: Recurrent opened macular hole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Individuals with recurrent macular hole associated retinal detachment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Procedure: Recurrent opened macular hole
pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade

Primary Outcome Measures :
  1. Anatomical restoration of macular hole closure [ Time Frame: 6 months ]
    Closure of the macular hole

Secondary Outcome Measures :
  1. Functional restoration after closure of the macular hole [ Time Frame: 6 months ]
    Improvement of the best corrected visual acuity (BCVA)

  2. Functional restoration after closure of the macular hole [ Time Frame: 6 months ]
    Any improvement of the waves in the electrophysiological (ERG) study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT03528122

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Minia UNiversity hospital
Minya, Minia, Egypt, 61111
Sponsors and Collaborators
Minia University
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Responsible Party: Hossam Mohamed Moharram, Assistant Professor of Ophthalmology, Minia University Identifier: NCT03528122    
Other Study ID Numbers: 63 2/2018
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Hossam Mohamed Moharram, Minia University:
amniotic membrane
retinal detachment
macular hole
internal limiting membrane
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Detachment
Retinal Perforations
Retinal Degeneration
Retinal Diseases
Eye Diseases