Brilliant Blue Versus Indocyanine Green

Sponsor

University of Cologne (Other)

Overall Status

Unknown status

CT.gov ID

NCT01083004

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2008

Anticipated Primary Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Best corrected far visual acuity (ETDRS) [1 year postoperative]

Secondary Outcome Measures

Reading ability (Radner) [1 Year]
Optical coherence tomography [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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