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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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The study is a prospective, multi-center, single-arm, non-randomized, non-blinded, observational study to evaluate the test-retest reliability of the Visibly Vision Test.
Additionally, observational data will be collected to understand whether the subject performs the set-up process correctly and subject comprehension of the patient labeling will also be evaluated.
Potentially eligible subjects who provide informed consent and are confirmed qualified will be presented a room simulating the home environment with, at minimum, a table; pair of internet-connected devices (if subject has not opted to use their own), as well as some common household items. Subjects will then be directed to visit the website clinical.opternative.com and follow instructions on the website to complete vision testing.
Following completion of the first test session, subjects will undergo a series of critical knowledge task questions administered by site staff to evaluate their understanding of the critical aspects of the proposed patient labeling. Subjects will not receive verbal feedback and the study staff will refrain from any non-verbal responses to the answers provided from the subjects.
At least four hours but not more than 72 hours from the completion of the first test, each subject will be asked to return to the testing room, and complete the Visibly Vision Test again, including repeating the on-boarding, set-up, test, and off-boarding processes.
Site staff will observe and document the second testing process in the same manner as for the subject's first test session.
Following completion of the second test (retest), subject participation will be considered complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | Without using an available refractive correction and whose refractive error is no greater than -1.00D of myopia (spherical component in minus cylinder format) and with no greater than -2.00D of astigmatism in either eye |
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| Cohort 2 | Other | With prior correction of no greater than -6.00D of myopia (spherical component in minus cylinder format) and require a spherical (non-astigmatic) over-refraction of no more than ±1.00 D in either eye |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visibly Vision Test | Device | The Visibly Vision Test is used as a digital self-administered device to measure visual acuity and to subjectively measure refractive value for a patient's eye to determine the optical prescription for the conditions of myopia and astigmatism |
| Measure | Description | Time Frame |
|---|---|---|
| Test-retest variability (repeatability) of the Visibly Vision Test in the measurement of refractive error as assessed by the repeatability standard deviation using the Visibly software numerical outputs of estimated refractive error/correction. | The refractive error measurements will be those given by the Visibly software numerical outputs of estimated refractive error/correction. For each component of the refractive error measured in diopters (sphere, cylinder, and spherical equivalent), the homogeneous repeatability will be assessed using repeated measurements within study eyes. | Retest conducted between four and 72 hours after initial test. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of subject comprehension of critical aspects of patient labeling using subject response forms. | Collection of response from subjects regarding their comprehension of critical aspects of patient labeling. | Performed immediately after initial test completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TRA | Harlingen | Texas | 78550 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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multi-center, single-arm, non-randomized, non-blinded, interventional study
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