Brilliant Blue Versus Indocyanine Green - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2010

Last Updated Date

April 15, 2011

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Best corrected far visual acuity (ETDRS) [ Time Frame: 1 year postoperative ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01083004 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reading ability (Radner) [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Optical coherence tomography [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

Brilliant Blue Versus Indocyanine Green

Official Title ^ICMJE

A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase III

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Macular Pucker
Macular Hole
Vitreoretinal Surgery

Intervention ^ICMJE

Procedure: Indocyanine green
Using indocyanine green as intraoperative dye
Procedure: Brilliant blue arm
Using brilliant blue as intraoperative dye

Study Arms

Active Comparator: Indocyanine green arm
Intervention: Procedure: Indocyanine green
Active Comparator: Brilliant blue
Intervention: Procedure: Brilliant blue arm

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Albert Caramoy, MD

004902214784308

acaramoy@yahoo.co.uk

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01083004

Other Study ID Numbers ^ICMJE

BlueIce001

Has Data Monitoring Committee

Responsible Party

Prof. Dr. B. Kirchhof, University of Cologne

Study Sponsor ^ICMJE

University of Cologne

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bernd Kirchhof, MD

University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany

Information Provided By

University of Cologne

Verification Date

October 2007

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