Brilliant Blue Versus Indocyanine Green

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083004
Recruitment Status : Unknown
Verified October 2007 by University of Cologne.
Recruitment status was:  Recruiting
First Posted : March 9, 2010
Last Update Posted : April 18, 2011
Information provided by:
University of Cologne

March 8, 2010
March 9, 2010
April 18, 2011
January 2008
May 2011   (Final data collection date for primary outcome measure)
Best corrected far visual acuity (ETDRS) [ Time Frame: 1 year postoperative ]
Visual acuity [ Time Frame: 1 year postoperative ]
Complete list of historical versions of study NCT01083004 on Archive Site
  • Reading ability (Radner) [ Time Frame: 1 Year ]
  • Optical coherence tomography [ Time Frame: 1 year ]
  • Quality of Life [ Time Frame: 1 Year ]
  • Optical coherence tomography [ Time Frame: 1 year ]
  • Electroretinography [ Time Frame: 1 year ]
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Brilliant Blue Versus Indocyanine Green
A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Macular Pucker
  • Macular Hole
  • Vitreoretinal Surgery
  • Procedure: Indocyanine green
    Using indocyanine green as intraoperative dye
  • Procedure: Brilliant blue arm
    Using brilliant blue as intraoperative dye
  • Active Comparator: Indocyanine green arm
    Intervention: Procedure: Indocyanine green
  • Active Comparator: Brilliant blue
    Intervention: Procedure: Brilliant blue arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age over 50
  • macular pucker or macular hole with subjective disturbances
  • All phakic or pseudophakic patients
  • far visual acuity better than 20/400
  • able to read, understand, and willing to sign the informed consent form

Exclusion Criteria:

  • any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
  • prior vitreoretinal surgery in the study eye
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Prof. Dr. B. Kirchhof, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Bernd Kirchhof, MD University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany
University of Cologne
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP