Status:
COMPLETED
Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
Lead Sponsor:
Carl Zeiss Meditec, Inc.
Collaborating Sponsors:
DataMed Devices Inc.
Conditions:
Dry AMD With Macular Drusen
Eligibility:
All Genders
50+ years
Brief Summary
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.
Detailed Description
This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two pha...
Eligibility Criteria
Inclusion
- Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
- Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
Exclusion
- History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
- Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
- Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
- Concomitant use of hydrochloroquine or chloroquine.
- Unable to make the required study visits.
- Unable to give consent or follow study instructions.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01890174
Start Date
February 1 2011
End Date
June 1 2011
Last Update
July 1 2013
Active Locations (1)
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1
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040