Brilliant Blue Versus Indocyanine Green

April 15, 2011 updated by: University of Cologne

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50924
        • Recruiting
        • Center of Ophthalmology, University of Cologne
        • Contact:
        • Sub-Investigator:
          • Albert Caramoy, MD
        • Principal Investigator:
          • Bernd Kirchhof, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best corrected far visual acuity (ETDRS)
Time Frame: 1 year postoperative
1 year postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Reading ability (Radner)
Time Frame: 1 Year
1 Year
Optical coherence tomography
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Bernd Kirchhof, MD, University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BlueIce001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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