Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Carl Zeiss Meditec, Inc.
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
Study Overview
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 phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.
Time Frame: Single visit observation
Secondary Outcomes
- Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.(Single visit observation)