Back to resultsSingle Superior ILM/ERM Flap for the FTMH.
Primary Purpose
Ophthalmopathy
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Surgical intervention
Sponsored by
About this trial
This is an interventional treatment trial for Ophthalmopathy focused on measuring Full thickness macular hole, Epiretinal membrane, Internal limiting membrane, Flap
Eligibility Criteria
Inclusion Criteria:
- Full thickness macular hole
Exclusion Criteria:
- Lamellar and pseudo holes
Sites / Locations
- Omer Othman Abdullah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single superior flap technique to secure macular hole closure.
Double flap technique to secure macular hole closure.
Arm Description
The patients are divided into two groups: For the first group, the flap will be carried out under the effect of perfluorocarbon. For the second group, the flap stabilized with methylcellulose.
This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique.
Outcomes
Primary Outcome Measures
Anatomical outcome
OCT
Secondary Outcome Measures
Functional outcome
Best corrected visual acuity
Full Information
NCT ID
NCT05494242
First Posted
August 6, 2022
Last Updated
March 23, 2023
Sponsor
Omer Othman Abdullah
Collaborators
Ibinsina Modern Eye and Retina Center
1. Study Identification
Unique Protocol Identification Number
NCT05494242
Brief Title
Single Superior ILM/ERM Flap for the FTMH.
Official Title
Single Superior Internal Limiting Membrane/Epiretinal Membrane Flap for the Full Thickness Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omer Othman Abdullah
Collaborators
Ibinsina Modern Eye and Retina Center
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
In this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.
Detailed Description
After the investigators completed the clinical trial NCT05269563, which was a double flap technique; that consists of two flaps from the internal limiting membrane and the epiretinal membrane. The inferior flap was implanted inside the hole, but the upper flap was utilized to cover the hole. The results were encouraging. Therefore, in this study, the investigators will make the only upper flap to cover the full thickness macular hole, to compare both visual and anatomical outcomes with the double flapped technique (NCT05269563) results. Therefore the double flap will be our control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ophthalmopathy
Keywords
Full thickness macular hole, Epiretinal membrane, Internal limiting membrane, Flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single superior flap technique to secure macular hole closure.
Arm Type
Experimental
Arm Description
The patients are divided into two groups:
For the first group, the flap will be carried out under the effect of perfluorocarbon.
For the second group, the flap stabilized with methylcellulose.
Arm Title
Double flap technique to secure macular hole closure.
Arm Type
Active Comparator
Arm Description
This arm is NCT05269563, we utilize the results as a comparator to the superior single flap technique.
Intervention Type
Other
Intervention Name(s)
Surgical intervention
Intervention Description
Pars-plana vitrectomy.
Primary Outcome Measure Information:
Title
Anatomical outcome
Description
OCT
Time Frame
The fourth weeks post-operatively
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Best corrected visual acuity
Time Frame
The fourth week post-operatively.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Full thickness macular hole
Exclusion Criteria:
Lamellar and pseudo holes
Facility Information:
Facility Name
Omer Othman Abdullah
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Both the best corrected visual acuity and the OCT.
IPD Sharing Time Frame
Expected to be available around the end of November 2022
IPD Sharing Access Criteria
via your permisson
Learn more about this trial
Single Superior ILM/ERM Flap for the FTMH.
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