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Brillant Blue Versus Indocyanine Green for Macular Hole Surgery

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ClinicalTrials.gov Identifier: NCT00757471
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Brief Summary:
Macular Hole Surgery with two different Dyes

Condition or disease Intervention/treatment Phase
Idiopathic Macular Holes Procedure: Brillant Blue Procedure: Indocyanine Green Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Membranepeeling With Brillant Blue Versus Membranepeeling With Indocyanine Green for Patients With Idiopathic Macular Holes.
Study Start Date : August 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1
Brillant Blue
Procedure: Brillant Blue
Membrane Peeling with Brillant Blue
Active Comparator: Group 2
Indocyanine Green
Procedure: Indocyanine Green
Membrane Peeling with indocyanine Green



Primary Outcome Measures :
  1. Macular Hole Closure Rate [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Visual Acuity Microperimetry Optical Coherence Tomography [ Time Frame: 12 Months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757471


Locations
Austria
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser surgery
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Study Chair: Katharina Kreppler, MD The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Principal Investigator: Christiane I Falkner-Radler, MD The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Responsible Party: Dr. Christiane I. Falkner-Radler, MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00757471     History of Changes
Other Study ID Numbers: FR-5-CI-2008
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
Macular hole surgery
membranepeeling
closure rate
vitreoretinal dyes

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases