Back to resultsAt-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
Primary Purpose
Visual Impairment, Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
With Try-on glasses
Sponsored by
About this trial
This is an interventional diagnostic trial for Visual Impairment
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- Ages 30+
- Had purchased an EyeQue refraction device.
- Obtained EGN's from the EyeQue refraction device.
- Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
- 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:
- Do not have a command of the English language.
- Lack the ability to follow instructions.
- Lack binocular vision.
- Are Color-blind.
Sites / Locations
- EyeQue
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Without Try-on glasses
Arm Description
Subjects will be asked to measure their visual acuity without their try-on glasses
Outcomes
Primary Outcome Measures
Visual Acuity with and without try-on glasses
Visual Acuity with and without try-on glasses
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04820218
Brief Title
At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
Official Title
An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeQue Corp.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Myopia, Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects who had previously tested with an EyeQue ophthalmic refraction device and ordered try-on glasses will be asked to measure their visual acuity with and without their try-on glasses.
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without Try-on glasses
Arm Type
Other
Arm Description
Subjects will be asked to measure their visual acuity without their try-on glasses
Intervention Type
Device
Intervention Name(s)
With Try-on glasses
Intervention Description
Subjects will be asked to measure their visual acuity with their try-on glasses
Primary Outcome Measure Information:
Title
Visual Acuity with and without try-on glasses
Description
Visual Acuity with and without try-on glasses
Time Frame
Visit 1: Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female
Ages 30+
Had purchased an EyeQue refraction device.
Obtained EGN's from the EyeQue refraction device.
Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
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:
Do not have a command of the English language.
Lack the ability to follow instructions.
Lack binocular vision.
Are Color-blind.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Sapiens, PhD
Organizational Affiliation
EyeQue Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
EyeQue
City
Newark
State/Province
California
ZIP/Postal Code
94560
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
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