NCT05026658

Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Visibly · Industry
• Sex: All
• Age: 22 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Visual acuity is the relative ability of the eye to resolve detail that is usually expressed as the reciprocal of the minimum angular separation in minutes of two lines just resolvable as separate and that forms in the average human eye an angle of one minute. Visibly Inc. has developed a method for determining a patient's visual acuity electronically via a web-based software system that can be self-administered wherever convenient. This method provides an efficient alternative for people to have immediate access to visual acuity measurements.

Detailed description

The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, at home, to evaluate visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices: * A computer screen (the Display) which displays optotypes * A touchscreen mobile device (the Remote) which operates as a remote control and interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's visual acuity into one of two buckets: * 20/25 or better * Worse than 20/25

Conditions

• Digital Acuity Product

Interventions

Type	Name	Description
DEVICE	Visibly Digital Acuity Product	The order of testing (two VDAP home environments and ETDRS) will be randomly assigned for each subject as one of four sequences: 1. V1, E, V2 2. E, V1, V2 3. V2, E, V1 4. E, V2, V1 Where E denotes the ETDRS assessment, V1 denotes the VDAP assessment in home environment 1, and V2 denotes the VDAP assessment in home environment 2. The randomization will be blocked in groups of 4 subjects to ensure balance for the VA testing sequences.

Timeline

• Start date: 2021-07-22
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2021-08-30
• Last updated: 2024-11-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study