Macular Hole Clinical Trial
Official title:
A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole
NCT number | NCT01083004 |
Other study ID # | BlueIce001 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | March 8, 2010 |
Last updated | April 15, 2011 |
Start date | January 2008 |
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Center of Ophthalmology, University of Cologne | Cologne | NRW |
Lead Sponsor | Collaborator |
---|---|
University of Cologne |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best corrected far visual acuity (ETDRS) | 1 year postoperative | Yes | |
Secondary | Reading ability (Radner) | 1 Year | Yes | |
Secondary | Optical coherence tomography | 1 year | No |
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