Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)

Completed

Conditions studied: Age Related Macular Degeneration, Geographic Atrophy

In brief

The objective of this study is to compare Cirrus HD-OCT automated measurements of the illumination area under the retinal pigment epithelium (RPE) to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images.

Key facts

Study ID

NCT01272076

Run by

Carl Zeiss Meditec, Inc.

People needed

85

Starts

2011-01-01

Expected to finish

2011-02-01

Last updated by the study team

2014-01-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.
• Geographic atrophy lesions should:
• Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
• Not be smaller than 1.25 mm2.
• Not be confluent with peri-papillary atrophy.
• Not be combined with other lesions such as CNVs.
• Able and willing to make the required study visit.
• Able and willing to give consent and follow study instructions.

You may not qualify if…

• 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 visit.
• Unable to give consent or follow study instructions.

Where it is running

• East Bay Retina Consultants, Inc. — Oakland, California, United States
• TLC Eyecare and Laser Centers — Jackson, Michigan, United States

Full record on ClinicalTrials.gov

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