Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

Completed

• Conditions: Drusen Stage Macular Degeneration

• Registration Number: NCT01272063
• Lead Sponsor: Carl Zeiss Meditec, Inc.

Brief Summary

The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).

Detailed Description

This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 upon dilated examination, or upon evaluation of retinal photos.
• Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
• Concomitant use of hydrochloroquine and chloroquine.
• Unable to make the required study visits.
• Unable to give consent or follow study instructions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.	Study was released before December 1, 2012

Secondary Outcome Measures

Name	Time	Method
To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.	Study was released before December 1, 2012

Trial Locations

Locations (4)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

TLC Eyecare and Laser Centers; 🇺🇸 Lansing, Michigan, United States

East Bay Retina; 🇺🇸 Oakland, California, United States

West Coast Retina; 🇺🇸 San Francisco, California, United States