Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
1 other identifier
interventional
40
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedAugust 4, 2020
August 1, 2020
1 year
July 22, 2020
August 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microperimetry retinal sensitivity
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 Outcomes (2)
Best corrected visual acuity (BCVA)
3 months
Closure rate
3 months
Study Arms (2)
inverted flap
ACTIVE COMPARATORpeeling internal limiting membrane (ILM)
ACTIVE COMPARATORInterventions
full thickness macular hole surgery
Eligibility Criteria
You may qualify if:
- \>18 years old
- idiopathic full thickness macular hole ≤ 350 micron of diameter
- phakic or pseudophakic
- absence of systemic adverse conditions
You may not qualify if:
- concomitant retinal and other ocular disease
- previous ocular surgery except cataract surgery
- axial length \>26mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Related Publications (1)
Ventre L, Fallico M, Longo A, Parisi G, Russo A, Bonfiglio V, Marolo P, Caselgrandi P, Avitabile T, Borrelli E, Reibaldi M. CONVENTIONAL INTERNAL LIMITING MEMBRANE PEELING VERSUS INVERTED FLAP FOR SMALL-TO-MEDIUM IDIOPATHIC MACULAR HOLE: A Randomized Trial. Retina. 2022 Dec 1;42(12):2251-2257. doi: 10.1097/IAE.0000000000003622. Epub 2022 Sep 6.
PMID: 36084331DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
July 22, 2020
First Posted
August 4, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
August 4, 2020
Record last verified: 2020-08