Brilliant Blue Versus Indocyanine Green

University of Cologne

Status and phase: Unknown; Phase 3

Conditions: Vitreoretinal Surgery; Macular Pucker; Macular Hole

Treatments: Procedure: Indocyanine green; Procedure: Brilliant blue arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01083004

BlueIce001

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Indocyanine green arm

Active Comparator group

Treatment:

Procedure: Indocyanine green

Brilliant blue

Active Comparator group

Treatment:

Procedure: Brilliant blue arm