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NCT01083004 Clinical Trial

Brilliant Blue Versus Indocyanine Green

Macular Hole Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01083004
Other study ID # BlueIce001
Secondary ID
Status Recruiting
Phase Phase 3
First received March 8, 2010
Last updated April 15, 2011
Start date January 2008

Study information
Verified date October 2007
Source University of Cologne
Contact Albert Caramoy, MD
Phone 004902214784308
Email acaramoy@yahoo.co.uk
Is FDA regulated No
Health authority Germany: University of Cologne
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Center of Ophthalmology, University of Cologne Cologne NRW

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best corrected far visual acuity (ETDRS) 1 year postoperative Yes
Secondary Reading ability (Radner) 1 Year Yes
Secondary Optical coherence tomography 1 year No
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