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Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

NCT05026658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2024-11-04

No results posted yet for this study

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.

Conditions

  • Digital Acuity Product

Interventions

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.

Sponsors & Collaborators

  • Visibly

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2021-10-04
Completion
2021-10-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026658 on ClinicalTrials.gov