Brilliant Blue Versus Indocyanine Green

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01083004

Enrollment

Registered

2010-03-09

Start date

2008-01-31

Completion date

Unknown

Last updated

2011-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole, Macular Pucker, Vitreoretinal Surgery

Keywords

dye, internal limiting membrane, macular hole, macular pucker

Brief summary

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

Interventions

PROCEDUREIndocyanine green

Using indocyanine green as intraoperative dye

PROCEDUREBrilliant blue arm

Using brilliant blue as intraoperative dye

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Best corrected far visual acuity (ETDRS)	1 year postoperative

Secondary

Measure	Time frame
Reading ability (Radner)	1 Year
Optical coherence tomography	1 year

Countries

Germany

Contacts

Primary ContactAlbert Caramoy, MD

acaramoy@yahoo.co.uk004902214784308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026