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Trial record 2 of 34 for:    myopic macular degeneration

Amniotic Membrane for Recurrent Macular Hole

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ClinicalTrials.gov Identifier: NCT03528122
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : March 7, 2019
Sponsor:
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 : 10 participants
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 : September 1, 2019
Estimated Study Completion Date : December 1, 2019

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03528122


Contacts
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Contact: Hossam a Moharram, MD +201006061381 hossammoharram@gmail.com
Contact: Mohamed Tarek A Moustafa, MD +201028218703 mtarekmoustafa@gmail.com

Locations
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Egypt
Minia UNiversity hospital Recruiting
Minya, Minia, Egypt, 61111
Contact: Hossam M Moharram, MD    +201006393838    hossammoharram@gmail.com   
Contact: Mohamed Tarek A Moustafa, MD    +201028218703    mtarekmoustafa@gmail.com   
Sub-Investigator: Mohamed Tarek A Moustafa, MD         
Sub-Investigator: Mohamed Farouk Othman, MD         
Sponsors and Collaborators
Minia University

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Responsible Party: Hossam Mohamed Moharram, Assistant Professor of Ophthalmology, Minia University
ClinicalTrials.gov Identifier: NCT03528122     History of Changes
Other Study ID Numbers: 63 2/2018
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
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
Myopic
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