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This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refraction with a Hand-held Refraction Device | Active Comparator | This is the device that will be compared to a standard device. |
|
| Autorefractor | Other | Standard Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQ103 | Device | Refraction device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants | Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart) for each eye from (pooled) trial frames created with the refraction values compared with those of an autorefractor analyzed with all age groups. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings | Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for each eye (pooled) from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata. o Age Groups: 18 - 29, 30 - 44, 45 - 65 | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
claustrophobia, fear of simulators, nyctophobia.
Per subject self-reporting: eye disease, including but not limited to:
Subjects that:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EyeQue | Recruiting | Newark | California | 94560 | United States |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Tester and subject for BCVA are masked as to which device and trial frames are from.
| Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings | Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for worse eye from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata. o Age Groups: All, 18 - 29, 30 - 44, 45 - 65 | Day 1 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |