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

• Sponsor: EyeQue Corp. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04820218
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.5
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Visual Impairment; Myopia; Hyperopia; Astigmatism	Device: With Try-on glasses	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Diagnostic
• Official Title: An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
• Actual Study Start Date: Apr 21, 2021
• Anticipated Primary Completion Date: Feb 5, 2023
• Anticipated Study Completion Date: Feb 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Acuity with and without try-on glasses [Visit 1: Day 0]

   Visual Acuity with and without try-on glasses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EyeQue	Newark	California	United States	94560

Sponsors and Collaborators

• EyeQue Corp.

Investigators

• Principal Investigator: Noam Sapiens, PhD, EyeQue Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EyeQue Corp.
• ClinicalTrials.gov Identifier: NCT04820218
• Other Study ID Numbers: EYEQUE - 008
• First Posted: Mar 29, 2021
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Vision Disorders; Vision, Low; Astigmatism; Hyperopia

Study Results

No Results Posted as of Aug 22, 2022