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Brilliant Blue Versus Indocyanine Green

U

University of Cologne

Status and phase

Unknown
Phase 3

Conditions

Vitreoretinal Surgery
Macular Pucker
Macular Hole

Treatments

Procedure: Brilliant blue arm
Procedure: Indocyanine green

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)

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

Trial contacts and locations

1

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Central trial contact

Albert Caramoy, MD

Data sourced from clinicaltrials.gov

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