Brilliant Blue Versus Indocyanine Green - Full Text View

Sponsor:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT01083004

Purpose

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

Condition	Intervention	Phase
Macular Pucker Macular Hole Vitreoretinal Surgery	Procedure: Indocyanine green Procedure: Brilliant blue arm	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Indocyanine green

Further study details as provided by University of Cologne:

Primary Outcome Measures:

Visual acuity [ Time Frame: 1 year postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Indocyanine green arm: Active Comparator	Procedure: Indocyanine green Using indocyanine green as intraoperative dye
Brilliant blue: Active Comparator	Procedure: Brilliant blue arm Using brilliant blue as intraoperative dye

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083004

Contacts

Contact: Albert Caramoy, MD

004902214784308

Locations

Germany, NRW
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

More Information

No publications provided

Responsible Party:	University of Cologne ( Prof. Dr. B. Kirchhof )
ClinicalTrials.gov Identifier:	NCT01083004 History of Changes
Other Study ID Numbers:	BlueIce001
Study First Received:	March 8, 2010
Last Updated:	March 8, 2010
Health Authority:	Germany: University of Cologne

Keywords provided by University of Cologne:

dye
internal limiting membrane
macular hole
macular pucker

Additional relevant MeSH terms:

Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 01, 2010