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

  • Clinicaltrials.gov identifier

    NCT03929588

  • Recruitment Status

    Recruiting

  • First Posted

    April 29, 2019

  • Last update posted

    November 21, 2019

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:Refractive Errors
    Astigmatism
  • Intervention/Treatment: Device: Hand-held device supported by a mobile application
    Device: Phoropter
    Device: Autorefractor
  • Phase: 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
  • Estimated Enrollment: 100 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.
  • 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 2019
  • Estimated Primary Completion Date: January 2020
  • Estimated Study Completion Date: January 2020

Arms and interventions

Arm Intervention/treatment
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.
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.
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

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 [ Time Frame: 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.
  • Secondary Outcome Measures: 1. BVCA utilizing refraction results from handheld device compared to automated refraction methods. [ Time Frame: Through study completion, an average of 5 months ]
    BVCA utilizing refraction results using the handheld device with supporting application will be compared to automated refraction methods (using an autorefractor).
  • 2. Assessing similarity of refraction values from the handheld device compared with the phoropter. [ Time Frame: Through study completion, an average of 5 months ]
    Assessing similarity of refraction values (sphere, cylinder, axis) from the handheld device with supporting application compared with the phoropter through comparative plots and correlations for the age stratum 30 through 65 years and 45 through 65 years.
  • 3. BVCA utilizing refraction results from handheld device compared to manual refraction methods for the age stratum 30 through 65 years. [ Time Frame: Through study completion, an average of 5 months ]
    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 30 through 65 years.
  • 4. Assessing similarity of refraction values from the handheld device compared with the autorefractor. [ Time Frame: Through study completion, an average of 5 months ]
    Assessing similarity of refraction values (sphere, cylinder, axis) from the handheld device with supporting application compared with the autorefractor through comparative plots and correlations for the age stratum 30 through 65 years and 45 through 65 years.

Eligibility Criteria

  • Ages Eligible for Study: 30 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

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 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

Contacts

Contact: Carmen Marin 310-645-4673 carmen@drjamespeace.com

Locations

United States, California
United Medical Research Institute
Inglewood

Sponsors and Collaborators

EyeQue Corp.

Investigators

Principal Investigator: James Peace, MD United Medical Research Institute

More Information

  • Responsible Party: EyeQue Corp.
  • ClinicalTrials.gov Identifier: NCT03929588 History of Changes
  • Other Study ID Numbers: EYEQUE - 001
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: November 21, 2019
  • Last Verified: August 2019
  • 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.: Yes
  • Keywords provided by EyeQue Corp.: myopia hyperopia
  • Additional relevant MeSH terms: Astigmatism Refractive Errors