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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

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ClinicalTrials.gov Identifier: NCT03929588
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
EyeQue Corp.

Study Description
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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
Refractive Errors Astigmatism Device: Hand-held device supported by a mobile application Device: Phoropter Device: Autorefractor Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 7, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

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Arms and Interventions
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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
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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
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Ages Eligible for Study:   30 Years 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 < -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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929588


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

Locations
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United States, California
United Medical Research Institute Recruiting
Inglewood, California, United States, 90301
Sponsors and Collaborators
EyeQue Corp.
Investigators
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Principal Investigator: James Peace, MD United Medical Research Institute
More Information
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Responsible Party: EyeQue Corp.
ClinicalTrials.gov Identifier: NCT03929588    
Other Study ID Numbers: EYEQUE - 001
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by EyeQue Corp.:
myopia
hyperopia
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases