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Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Primary Purpose

Full Thickness Macular Hole

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
inverted flap
peeling internal limiting membrane (ILM)
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Full Thickness Macular Hole focused on measuring Full thickness macular hole, Vitrectomy, Inverted flap, Internal limiting membrane peeling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O.U. Città della Salute e della Scienza di TorinoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

inverted flap

peeling internal limiting membrane (ILM)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best corrected visual acuity (BCVA)
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
Closure rate
Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

Full Information

First Posted
July 22, 2020
Last Updated
August 3, 2020
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT04498624
Brief Title
Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
Official Title
Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Macular Hole
Keywords
Full thickness macular hole, Vitrectomy, Inverted flap, Internal limiting membrane peeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inverted flap
Arm Type
Active Comparator
Arm Title
peeling internal limiting membrane (ILM)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
inverted flap
Intervention Description
full thickness macular hole surgery
Intervention Type
Procedure
Intervention Name(s)
peeling internal limiting membrane (ILM)
Intervention Description
full thickness macular hole surgery
Primary Outcome Measure Information:
Title
Microperimetry retinal sensitivity
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA)
Description
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
Time Frame
3 months
Title
Closure rate
Description
Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MIchele Reibaldi, MD
Phone
0116331863
Email
michele.reibaldi@unito.it
Facility Information:
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MIchele Reibaldi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36084331
Citation
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.
Results Reference
derived

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Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

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