Brilliant Blue Versus Indocyanine Green

University of Cologne50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Macular Pucker Macular Hole Vitreoretinal Surgery

Interventions

Indocyanine greenPROCEDURE

Using indocyanine green as intraoperative dye

Brilliant blue armPROCEDURE

Using brilliant blue as intraoperative dye

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Center of Ophthalmology, University of Cologne

Cologne, North Rhine-Westphalia, Germany

RECRUITING

Outcomes

Primary Outcomes

Best corrected far visual acuity (ETDRS)

Time frame: 1 year postoperative

Secondary Outcomes

Reading ability (Radner)

Time frame: 1 Year

Optical coherence tomography

Time frame: 1 year

Central Contacts

Albert Caramoy, MD

CONTACT

004902214784308 acaramoy@yahoo.co.uk

Data from ClinicalTrials.gov

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