- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04498624
Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
August 3, 2020 updated by: Michele Reibaldi, University of Turin, Italy
Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Torino, Italy, 10126
- Recruiting
- A.O.U. Città della Salute e della Scienza di Torino
-
Contact:
- MIchele Reibaldi, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- >18 years old
- idiopathic full thickness macular hole ≤ 350 micron of diameter
- phakic or pseudophakic
- absence of systemic adverse conditions
Exclusion Criteria:
- concomitant retinal and other ocular disease
- previous ocular surgery except cataract surgery
- axial length >26mm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: inverted flap
|
full thickness macular hole surgery
|
Active Comparator: peeling internal limiting membrane (ILM)
|
full thickness macular hole surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microperimetry retinal sensitivity
Time Frame: 3 months
|
Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity (BCVA)
Time Frame: 3 months
|
Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
|
3 months
|
Closure rate
Time Frame: 3 months
|
Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
May 1, 2021
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (Actual)
August 4, 2020
Study Record Updates
Last Update Posted (Actual)
August 4, 2020
Last Update Submitted That Met QC Criteria
August 3, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0062156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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