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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

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Detailed Description

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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.

Conditions

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Dry AMD With Macular Drusen

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AMD with macular drusen

Patients diagnosed with dry AMD with macular drusen

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No