Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium

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

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).

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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 illumination areas under the RPE will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of illumination areas under the RPE 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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Advanced Dry AMD With Geographic Atrophy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Advanced dry AMD with geographic atrophy

Patients diagnosed with advanced dry AMD with geographic atrophy

No interventions assigned to this group

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 CNV.
* 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.
* Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
* Concomitant use of hydrochloroquine or chloroquine.
* Unable to make the required study visits.
* Unable to give consent or follow study instructions.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No