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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

Brief Summary:
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.

Condition or disease Intervention/treatment Phase
Macular Pucker Macular Hole Vitreoretinal Surgery Procedure: Indocyanine green Procedure: Brilliant blue arm Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
Study Start Date : January 2008
Estimated Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Indocyanine green arm Procedure: Indocyanine green
Using indocyanine green as intraoperative dye

Active Comparator: Brilliant blue Procedure: Brilliant blue arm
Using brilliant blue as intraoperative dye

Primary Outcome Measures :
  1. Best corrected far visual acuity (ETDRS) [ Time Frame: 1 year postoperative ]

Secondary Outcome Measures :
  1. Reading ability (Radner) [ Time Frame: 1 Year ]
  2. Optical coherence tomography [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01083004

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Contact: Albert Caramoy, MD 004902214784308

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Center of Ophthalmology, University of Cologne Recruiting
Cologne, NRW, Germany, 50924
Contact: Albert Caramoy, MD    004902214784308   
Sub-Investigator: Albert Caramoy, MD         
Principal Investigator: Bernd Kirchhof, MD         
Sponsors and Collaborators
University of Cologne
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Principal Investigator: Bernd Kirchhof, MD University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany
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Responsible Party: Prof. Dr. B. Kirchhof, University of Cologne Identifier: NCT01083004    
Other Study ID Numbers: BlueIce001
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: October 2007
Keywords provided by University of Cologne:
internal limiting membrane
macular hole
macular pucker
Additional relevant MeSH terms:
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Retinal Perforations
Epiretinal Membrane
Retinal Diseases
Eye Diseases