At-home Testing Refraction Results With Best Corrected Vi... | NCT04820218

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

NCT04820218

Sponsor

EyeQue Corp.

Status

Completed

Last Update Posted

Jan 25, 2023Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Visual Impairment
Myopia
Hyperopia
Astigmatism

Interventions

With Try-on glasses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2021Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Mar 24, 2021

First Posted Date

Mar 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2023

Last Update Posted Date

Jan 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without Try-on glasses	Other	Subjects will be asked to measure their visual acuity without their try-on glasses	Device: With Try-on glasses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With Try-on glasses	Device	Subjects will be asked to measure their visual acuity with their try-on glasses	Without Try-on glasses

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noam Sapiens, PhD	EyeQue Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EyeQue		Newark	California	94560	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014786	Vision Disorders
D009216	Myopia
D006956	Hyperopia
D001251	Astigmatism

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided