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

Study Overview
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Brief Summary
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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.

Detailed Description
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Specific Objectives: To compare Cirrus HD-OCT automated measurements of the illumination area under the RPE to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images. To describe the differences and similarities between Cirrus HD-OCT and fundus autofluorescence images of subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD). To determine the clinical factors that affect the Cirrus HD-OCT automated measurements of the illumination area under the RPE.

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

Conditions
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Age Related Macular Degeneration, Geographic Atrophy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 visit. Unable to give consent or follow study instructions.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dry AMD and geographic atrophy<br>Patients diagnosed with dry AMD and geographic atrophy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA). | In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists. | August 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age Related Macular Degeneration, Geographic Atrophy, Imaging, OCT