Back to resultsComparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Primary Purpose
Macular Holes, Retina Detachment
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vitrectomy with or without inverted ILM flap technique
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes
Eligibility Criteria
Inclusion Criteria: macular hole retinal detachment in high myopic eyes.
-
Exclusion Criteria:
- eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.
Sites / Locations
- Alexandria university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
vitrectomy without ILM peeling
vitrectomy with inverted ILM flap technique
Arm Description
vitrectomy without ILM peeling
vitrectomy with inverted ILM flap technique
Outcomes
Primary Outcome Measures
visual acuity at one year
Secondary Outcome Measures
rate of retinal attachment and macular hole closure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04011007
Brief Title
Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Official Title
Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to determine whether inverted ILM peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (MHRD) in comparison to no ILM peeling.
This retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. Exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery.
Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or without cataract surgery.
Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes, Retina Detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitrectomy without ILM peeling
Arm Type
Active Comparator
Arm Description
vitrectomy without ILM peeling
Arm Title
vitrectomy with inverted ILM flap technique
Arm Type
Active Comparator
Arm Description
vitrectomy with inverted ILM flap technique
Intervention Type
Procedure
Intervention Name(s)
vitrectomy with or without inverted ILM flap technique
Intervention Description
vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes.
Primary Outcome Measure Information:
Title
visual acuity at one year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
rate of retinal attachment and macular hole closure.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: macular hole retinal detachment in high myopic eyes.
-
Exclusion Criteria:
eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.
Facility Information:
Facility Name
Alexandria university
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
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