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Assess the performance and usability of the RHMS Visual Acuity Module.
This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal subjects | Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye. |
| |
| Subjects with neovascular AMD | Age ≥ 50 years, History of neovascular age-related macular degeneration, in the study eye, Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinal Health Monitoring System Visual Acuity Module | Diagnostic Test | Assessment of corrected near visual acuity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart | To determine the precision (repeatability and reproducibility) of corrected near visual acuity (CNVA) measured by the RHMS Visual Acuity Module and an in-clinic, near logarithmic Sloan Letter chart (Reference Chart). | 1 day |
| Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart | To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart | 1 day |
| Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart | To evaluate the usability of the RHMS Visual Acuity Module | 1 day |
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Inclusion Criteria:
Cohort 1 - Normal subjects
Cohort 2 - Subjects with neovascular AMD
Exclusion Criteria:
Cohort 1 - Normal subjects
Cohort 2 - Subjects with neovascular AMD
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Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Gregory, MD | Kubota Vision Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Arizona | Phoenix | Arizona | 85053 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Sloan letter, logarithmic near visual acuity chart (Reference Chart) | Diagnostic Test | Assessment of corrected near visual acuity |
|