- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01083004
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 Contact
- Name: Albert Caramoy, MD
- Phone Number: 004902214784308
- Email: acaramoy@yahoo.co.uk
Study Locations
-
-
NRW
-
Cologne, NRW, Germany, 50924
- Recruiting
- Center of Ophthalmology, University of Cologne
-
Contact:
- Albert Caramoy, MD
- Phone Number: 004902214784308
- Email: acaramoy@yahoo.co.uk
-
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
|
Using indocyanine green as intraoperative dye
|
Active Comparator: Brilliant blue
|
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
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
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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