Brillant Blue Versus Indocyanine Green for Macular Hole Surgery

NCT ID: NCT00757471

Last Updated: 2016-01-26

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-08-31

Brief Summary

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Macular Hole Surgery with two different Dyes

Detailed Description

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Conditions

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Idiopathic Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

Brillant Blue

Group Type ACTIVE_COMPARATOR

Brillant Blue

Intervention Type PROCEDURE

Membrane Peeling with Brillant Blue

Group 2

Indocyanine Green

Group Type ACTIVE_COMPARATOR

Indocyanine Green

Intervention Type PROCEDURE

Membrane Peeling with indocyanine Green

Interventions

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Brillant Blue

Membrane Peeling with Brillant Blue

Intervention Type PROCEDURE

Indocyanine Green

Membrane Peeling with indocyanine Green

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Idiopathic stage 3 and 4 macular holes
* Stage 2 macular holes, followed up for at least 6 months
* Pseudophakic and phakic eyes
* Age over 60 years

Exclusion Criteria

* Traumatic macular holes
* Secondary macular holes
* Severe ocular diseases
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christiane I. Falkner-Radler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katharina Kreppler, MD

Role: STUDY_CHAIR

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Christiane I Falkner-Radler, MD

Role: PRINCIPAL_INVESTIGATOR

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Locations

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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FR-5-CI-2008

Identifier Type: -

Identifier Source: org_study_id

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