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Brilliant Blue Versus Indocyanine Green

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ClinicalTrials.gov 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
Sponsor:
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

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

U.S. FDA Resources

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01083004


Contacts
Contact: Albert Caramoy, MD 004902214784308 acaramoy@yahoo.co.uk

Locations
Germany
Center of Ophthalmology, University of Cologne Recruiting
Cologne, NRW, Germany, 50924
Contact: Albert Caramoy, MD    004902214784308    acaramoy@yahoo.co.uk   
Sub-Investigator: Albert Caramoy, MD         
Principal Investigator: Bernd Kirchhof, MD         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Bernd Kirchhof, MD University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany

Responsible Party: Prof. Dr. B. Kirchhof, University of Cologne
ClinicalTrials.gov Identifier: NCT01083004     History of Changes
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:
dye
internal limiting membrane
macular hole
macular pucker

Additional relevant MeSH terms:
Retinal Perforations
Epiretinal Membrane
Retinal Diseases
Eye Diseases