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

Carl Zeiss Meditec

Status: Completed

Conditions: Drusen Stage Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT01272063

HD-OCT-DR-2010-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

91 participants in 1 patient group

Dry AMD with macular drusen

Description:

Patients diagnosed with dry AMD with macular drusen