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| Name | Class |
|---|---|
| DataMed Devices Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced dry AMD with geographic atrophy | Patients diagnosed with advanced dry AMD with geographic atrophy |
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| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation for area of increased illumination under the RPE (mm^2) | Single visit observation |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation of the closest distance to fovea | Single visit observation |
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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:
Able and willing to make the required study visits.
Able and willing to give consent and follow study instructions.
Exclusion Criteria:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Lujan, MD | West Coast Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Retina | Walnut Creek | California | 94107 | United States |
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