Brilliant Blue Versus Indocyanine Green

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01083004
First received: March 8, 2010
Last updated: April 15, 2011
Last verified: October 2007

March 8, 2010
April 15, 2011
January 2008
May 2011   (final data collection date for primary outcome measure)
Best corrected far visual acuity (ETDRS) [ Time Frame: 1 year postoperative ] [ Designated as safety issue: Yes ]
Visual acuity [ Time Frame: 1 year postoperative ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01083004 on ClinicalTrials.gov Archive Site
  • Reading ability (Radner) [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • Optical coherence tomography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Optical coherence tomography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Electroretinography [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
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
Both
50 Years and older
No
Contact: Albert Caramoy, MD 004902214784308 acaramoy@yahoo.co.uk
Germany
 
NCT01083004
BlueIce001
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