Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation

Completed

• Conditions: Dry AMD With Macular Drusen

• Registration Number: NCT01890174
• Lead Sponsor: Carl Zeiss Meditec, Inc.

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 Timeline

• Study Start: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-27
• Last Update Submitted: 2013-06-27
• Study First Posted: 2013-07-01
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
2. Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
3. Able and willing to make the required study visits.
4. Able and willing to give consent and follow study instructions.

Exclusion Criteria

1. History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
2. Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
3. Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
4. Concomitant use of hydrochloroquine or chloroquine.
5. Unable to make the required study visits.
6. Unable to give consent or follow study instructions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.	Single visit observation

Secondary Outcome Measures

Name	Time	Method
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.	Single visit observation

Trial Locations

Locations (1)

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States