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| Name | Class |
|---|---|
| Eye Boutique Optometry | UNKNOWN |
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Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age.
The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual Acuity with a Hand-held Device Supported by Mobile App. | Experimental | The Insight will be compared to a standard ETDRS eyechart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeQue Insight | Device | The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acuity Visit 1 | Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1. | Visit 1: Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Acuity Visit 1 and 2 | Variance of the best-corrected VA (BCVA) of each participant's OD, OS, and OU measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1 and Visit 2. | Visit 1 (Day 0) and Visit 2 (Day 7) |
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Inclusion Criteria:
Exclusion Criteria:
Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
Has traveled outside the country within the last 4 weeks
Medications:
a. Taking medications that may affect ability to follow instructions.
Eye Disease:
a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection.
Subjects that:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EyeQue | Newark | California | 94560 | United States |
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