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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01083004 |
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Date of registration:
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08/03/2010 |
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Primary sponsor: |
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Public title:
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Brilliant Blue Versus Indocyanine Green
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Scientific title:
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A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01083004 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Albert Caramoy, MD |
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Address:
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Telephone:
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004902214784308 |
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Email:
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acaramoy@yahoo.co.uk |
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Affiliation:
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Name:
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Albert Caramoy, MD |
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Address:
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Telephone:
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004902214784308 |
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Email:
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acaramoy@yahoo.co.uk |
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Affiliation:
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Name:
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Bernd Kirchhof, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cologne, Center of Ophthalmology, 50924 Cologne, Germany |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Macular Hole
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Macular Pucker
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Vitreoretinal Surgery
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Intervention(s)
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Procedure: Brilliant blue arm
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Procedure: Indocyanine green
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Primary Outcome(s)
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Best corrected far visual acuity (ETDRS)
[Time Frame: 1 year postoperative]
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Secondary Outcome(s)
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Optical coherence tomography
[Time Frame: 1 year]
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Reading ability (Radner)
[Time Frame: 1 Year]
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Secondary ID(s)
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BlueIce001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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