NCT06812572

A Prospective Clinical Study to Evaluate the Repeatability of the Visibly Vision Test

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Visibly · Industry
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Visibly Vision Test	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

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-03-25
• Completion: 2019-03-25
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study