Back to resultsILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
Primary Purpose
Macular Holes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
ILM flap transposition
ILM peeling
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes
Eligibility Criteria
Inclusion Criteria:
- macular hole with a diameter <400µm
Exclusion Criteria:
- Prior ILM peeling
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ILM flap
ILM peeling
Arm Description
vitrectomy with ILM flap transposition and gas-tamponade will be performed
vitrectomy with ILM peeling and gas-tamponade will be performed
Outcomes
Primary Outcome Measures
closure of the macular hole
closure of the macular hole will be assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT03646695
First Posted
August 23, 2018
Last Updated
August 21, 2021
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT03646695
Brief Title
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
Official Title
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with macular hole <400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes
Detailed Description
Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter <400µm. Therefore, patients with macular hole with a diameter <400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ILM flap
Arm Type
Experimental
Arm Description
vitrectomy with ILM flap transposition and gas-tamponade will be performed
Arm Title
ILM peeling
Arm Type
Active Comparator
Arm Description
vitrectomy with ILM peeling and gas-tamponade will be performed
Intervention Type
Procedure
Intervention Name(s)
ILM flap transposition
Intervention Description
during ILM flap Transposition, an ILM flap is placed on the macular hole
Intervention Type
Procedure
Intervention Name(s)
ILM peeling
Intervention Description
during ILM Peeling the ILM is removed around the macular hole
Primary Outcome Measure Information:
Title
closure of the macular hole
Description
closure of the macular hole will be assessed
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
macular hole with a diameter <400µm
Exclusion Criteria:
Prior ILM peeling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Professor
Organizational Affiliation
Head of Department of Ophthalmology, Professor, Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
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