Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Sponsor
EyeQue Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT03929588
Collaborator
(none)
230
1
3
10.8
21.3

Study Details

Study Description

Brief Summary

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.

Condition or Disease Intervention/Treatment Phase
  • Device: Hand-held device supported by a mobile application
  • Device: Phoropter
  • Device: Autorefractor
N/A

Detailed Description

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.

Study Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye
Actual Study Start Date :
May 7, 2019
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Refraction with a Hand-held Device Supported by Mobile App.

BCVA with handheld device with app.

Device: Phoropter
Manual refraction and ETDRS chart

Device: Autorefractor
Automated refraction

Active Comparator: Manual Refraction

BCVA with phoropter

Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.

Active Comparator: Automated Refraction

BCVA with autorefractoer

Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.

Outcome Measures

Primary Outcome Measures

  1. BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years [Through study completion, an average of 5 months]

    Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Male or Female

  • Age 30 through 65 years at the time of consent

  • Binocular vision

  • Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)

  • Willing and able to give informed consent and follow all study procedures and requirements

  • Ability to speak and understand the English language

Exclusion Criteria:
  • Spherical correction > +8 or < -10

  • Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study

  • Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study

  • Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the device

  • Eye disease, including but not limited to:

  • Glaucoma (≥ 22 mmHg intraocular pressure)

  • Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])

  • Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)

  • Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)

  • Keratoconus

  • Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)

  • Cytomegalovirus retinitis

  • Color blindness (any color deficiency)

  • Diabetic macular edema (evidence of fluid)

  • Amblyopia

  • Chronic or acute uveitis (cells and/or flare in anterior chamber)

  • Strabismus (exotropia, esotropia, and hypertropia)

  • Abnormal astigmatism (mild to severe, > 5 diopters)

  • Macular hole

  • Eye surgery within the last 12 months (including Lasik or lens replacement)

  • Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.

Contacts and Locations

Locations

Site City State Country Postal Code
1 United Medical Research Institute Inglewood California United States 90301

Sponsors and Collaborators

  • EyeQue Corp.

Investigators

  • Principal Investigator: James Peace, MD, United Medical Research Institute

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
EyeQue Corp.
ClinicalTrials.gov Identifier:
NCT03929588
Other Study ID Numbers:
  • EYEQUE - 001
First Posted:
Apr 29, 2019
Last Update Posted:
Mar 24, 2022
Last Verified:
Feb 1, 2022
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
Keywords provided by EyeQue Corp.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title All Participants
Arm/Group Description BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
Period Title: Overall Study
STARTED 230
COMPLETED 143
NOT COMPLETED 87

Baseline Characteristics

Arm/Group Title Refraction With a Hand-held Device Supported by Mobile App.
Arm/Group Description BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
Overall Participants 230
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
230
100%
>=65 years
0
0%
Sex: Female, Male (Count of Participants)
Female
115
50%
Male
115
50%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
Title BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years
Description Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.
Time Frame Through study completion, an average of 5 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Arm/Group Description BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
Measure Participants 143
BCVA handheld device
0.06
BCVA manual refraction
0.02
BCVA automated refraction
0.03

Adverse Events

Time Frame 6 months
Adverse Event Reporting Description No difference from standard definition. None observed.
Arm/Group Title Refraction With a Hand-held Device Supported by Mobile App.
Arm/Group Description BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction
All Cause Mortality
Refraction With a Hand-held Device Supported by Mobile App.
Affected / at Risk (%) # Events
Total 0/230 (0%)
Serious Adverse Events
Refraction With a Hand-held Device Supported by Mobile App.
Affected / at Risk (%) # Events
Total 0/230 (0%)
Other (Not Including Serious) Adverse Events
Refraction With a Hand-held Device Supported by Mobile App.
Affected / at Risk (%) # Events
Total 0/230 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title VP Science and Technology
Organization EyeQue
Phone 5104558168
Email noam.sapiens@eyeque.com
Responsible Party:
EyeQue Corp.
ClinicalTrials.gov Identifier:
NCT03929588
Other Study ID Numbers:
  • EYEQUE - 001
First Posted:
Apr 29, 2019
Last Update Posted:
Mar 24, 2022
Last Verified:
Feb 1, 2022