Back to resultsAmniotic Membrane for Recurrent Macular Hole
Primary Purpose
Macula Hole, Retinal Detachment, Myopic Macular Degeneration
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Recurrent opened macular hole
Sponsored by
About this trial
This is an interventional treatment trial for Macula Hole focused on measuring amniotic membrane, retinal detachment, Myopic, macular hole, internal limiting membrane
Eligibility 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.
Sites / Locations
- Minia UNiversity hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recurrent opened macular hole
Arm Description
Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft
Outcomes
Primary Outcome Measures
Anatomical restoration of macular hole closure
Closure of the macular hole
Secondary Outcome Measures
Functional restoration after closure of the macular hole
Improvement of the best corrected visual acuity (BCVA)
Functional restoration after closure of the macular hole
Any improvement of the waves in the electrophysiological (ERG) study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03528122
Brief Title
Amniotic Membrane for Recurrent Macular Hole
Official Title
The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macula Hole, Retinal Detachment, Myopic Macular Degeneration
Keywords
amniotic membrane, retinal detachment, Myopic, macular hole, internal limiting membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Individuals with recurrent macular hole associated retinal detachment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recurrent opened macular hole
Arm Type
Experimental
Arm Description
Pars plana vitrectomy with internal limiting membrane peel if not peeled in the first surgery and application of amniotic membrane graft
Intervention Type
Procedure
Intervention Name(s)
Recurrent opened macular hole
Intervention Description
pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade
Primary Outcome Measure Information:
Title
Anatomical restoration of macular hole closure
Description
Closure of the macular hole
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional restoration after closure of the macular hole
Description
Improvement of the best corrected visual acuity (BCVA)
Time Frame
6 months
Title
Functional restoration after closure of the macular hole
Description
Any improvement of the waves in the electrophysiological (ERG) study.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Minia UNiversity hospital
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Amniotic Membrane for Recurrent Macular Hole
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