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

NCT ID: NCT04498624

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-05-01

Brief Summary

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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

Detailed Description

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Conditions

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Full Thickness Macular Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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inverted flap

Group Type ACTIVE_COMPARATOR

inverted flap

Intervention Type PROCEDURE

full thickness macular hole surgery

peeling internal limiting membrane (ILM)

Group Type ACTIVE_COMPARATOR

peeling internal limiting membrane (ILM)

Intervention Type PROCEDURE

full thickness macular hole surgery

Interventions

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inverted flap

full thickness macular hole surgery

Intervention Type PROCEDURE

peeling internal limiting membrane (ILM)

full thickness macular hole surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Michele Reibaldi

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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A.O.U. Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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MIchele Reibaldi, MD

Role: CONTACT

0116331863

Facility Contacts

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MIchele Reibaldi, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36084331 (View on PubMed)

Other Identifiers

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0062156

Identifier Type: -

Identifier Source: org_study_id

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