Double Flap Technique for Macular Hole
Primary Purpose
Macular Holes
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 Macular Holes focused on measuring Double Flaps
Eligibility Criteria
Inclusion Criteria:
- Full thickness macular hole
Exclusion Criteria:
- Partial-thickness macular hole
- Vitreomacular traction
Sites / Locations
- Ibinsina Modern eye and retina center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Double flap technique to secure macular hole closure.
Arm Description
Single ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried.
Outcomes
Primary Outcome Measures
Ocular coherence tomography
The closure of the hole can be assessed clearly
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05269563
Brief Title
Double Flap Technique for Macular Hole
Official Title
Double Flap Technique Utilizing ERM and ILM for Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omer Othman Abdullah
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
Double flapping technique to close the macular hole.
Detailed Description
Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.
Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.
Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.
The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
Double Flaps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double flap technique to secure macular hole closure.
Arm Type
Experimental
Arm Description
Single ILM flap technique is already performing worldwide; however, sometimes it is associated with flap displacement. To overcome this issue, the double flap technique was tried.
Intervention Type
Other
Intervention Name(s)
Surgical intervention
Intervention Description
Pars Plana Vitrectomy for Macular Hole Closure
Primary Outcome Measure Information:
Title
Ocular coherence tomography
Description
The closure of the hole can be assessed clearly
Time Frame
The fourth week post-operatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Full thickness macular hole
Exclusion Criteria:
Partial-thickness macular hole
Vitreomacular traction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Abdullah, M.Sc.
Organizational Affiliation
Ibinsina Modern Eye and Retina Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ibinsina Modern eye and retina center
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Double Flap Technique for Macular Hole
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