Brilliant Blue Versus Indocyanine Green

Phase 3

• Conditions: Macular Pucker; Macular Hole; Vitreoretinal Surgery
• Interventions: Procedure: Indocyanine green; Procedure: Brilliant blue arm

• Registration Number: NCT01083004
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-10
• Study Start: 2008-01
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Last Update Submitted: 2011-04-15
• Last Update Posted: 2011-04-18
• Primary Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indocyanine green arm	Indocyanine green	-
Brilliant blue	Brilliant blue arm	-

Primary Outcome Measures

Name	Time	Method
Best corrected far visual acuity (ETDRS)	1 year postoperative

Secondary Outcome Measures

Name	Time	Method
Reading ability (Radner)	1 Year
Optical coherence tomography	1 year

Trial Locations

Locations (1)

Center of Ophthalmology, University of Cologne; 🇩🇪 Cologne, NRW, Germany