At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults

January 20, 2023 updated by: EyeQue Corp.

An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults

This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. The refraction measurements that users obtain from the VisionCheck are from testing at-home and without additional guidance other than that normally provided to those purchasing the device.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newark, California, United States, 94560
        • EyeQue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or Female
  2. Ages 30+
  3. Had purchased an EyeQue refraction device.
  4. Obtained EGN's from the EyeQue refraction device.
  5. Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
  6. Allow use for this study the VisionCheck refraction and try-on glasses measurements, taken prior to study participation.

Subject Exclusion Criteria, Subjects that by self-report:

  1. Do not have a command of the English language.
  2. Lack the ability to follow instructions.
  3. Lack binocular vision.
  4. Are Color-blind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Without Try-on glasses
Subjects will be asked to measure their visual acuity without their try-on glasses
Device: With Try-on glasses
Subjects will be asked to measure their visual acuity with their try-on glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity with and without try-on glasses
Time Frame: Visit 1: Day 0
Visual Acuity with and without try-on glasses
Visit 1: Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeQue Corp.

Investigators

  • Principal Investigator: Noam Sapiens, PhD, EyeQue Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYEQUE - 008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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