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

NCT ID: NCT06812572

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2019-03-25

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Cohort 1

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

Group Type: OTHER

Visibly Vision Test

Intervention Type: 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

Cohort 2

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

Group Type: OTHER

Visibly Vision Test

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female, age 22 to 55 years at the time of consent;Recent (within 24 months) in-person comprehensive eye examination with a licensed eyecare professional and have prior prescription values (sphere, cylinder, axis) available;Subject must have either documented recent refractive error not greater than -1.00D of myopia and no greater than -2.00D astigmatism in either eye or documented prior correction no greater than -6.00D of myopia in either eye. Subject are without known existing eye disease or history of systemic disease that may affect the eye; Subjects with known BCVA of 20/32 or better per recent prescription

Exclusion Criteria

• Subject has had prior use of the Visibly Vision Test; Subjects with known diabetes mellitus; Subjects using ophthalmic or systemic corticosteroids; Subjects with known autoimmune conditions (e.g. Grave's disease, rheumatoid arthritis); Subjects with active corneal or conjunctival infection;Subjects with active corneal, conjunctival, or intraocular inflammation (i.e., uveitis); Subjects with known diabetic retinopathy; Subjects with known glaucoma or ocular hypertension; Subjects with known macular degeneration; Subjects with previous ocular surgery; Subjects using antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex); Subjects with a history of measured spherical difference between left and right eye of 4.00 D or greater;

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Visibly

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TRA

Harlingen, Texas, United States

Countries

United States

Other Identifiers

VVT-1002

Identifier Type: -

Identifier Source: org_study_id