ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

NCT ID: NCT03646695

Last Updated: 2021-08-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-05-01

Brief Summary

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Patients with macular hole \<400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes

Detailed Description

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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

Conditions

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Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ILM flap

vitrectomy with ILM flap transposition and gas-tamponade will be performed

Group Type EXPERIMENTAL

ILM flap transposition

Intervention Type PROCEDURE

during ILM flap Transposition, an ILM flap is placed on the macular hole

ILM peeling

vitrectomy with ILM peeling and gas-tamponade will be performed

Group Type ACTIVE_COMPARATOR

ILM peeling

Intervention Type PROCEDURE

during ILM Peeling the ILM is removed around the macular hole

Interventions

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ILM flap transposition

during ILM flap Transposition, an ILM flap is placed on the macular hole

Intervention Type PROCEDURE

ILM peeling

during ILM Peeling the ILM is removed around the macular hole

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* macular hole with a diameter \<400µm

Exclusion Criteria

* Prior ILM peeling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Head of Department of Ophthalmology, Professor, Principal Investigator, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Professor

Role: PRINCIPAL_INVESTIGATOR

Head of Department of Ophthalmology, Professor, Principal Investigator

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ILM flap

Identifier Type: -

Identifier Source: org_study_id

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