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

Last updated: February 28, 2022
Sponsor: EyeQue Corp.
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Astigmatism

Treatment

N/A

Clinical Study ID

NCT03929588
EYEQUE - 001
  • Ages 30-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 correctedin each eye to 20/20 (LogMAR 0.0)
  • Willing and able to give informed consent and follow all study procedures andrequirements
  • Ability to speak and understand the English language

Exclusion

Exclusion Criteria:

  • Spherical correction > +8 or < -10
  • Using anticholinergic medications (including first-generation antihistamines) or othermedications known to affect visual acuity within the greater of 3 days or 5 half-livesprior to enrolling in this study
  • Using an investigational drug or approved therapy for investigational use within thegreater 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 medicaljudgment of the investigator, would impact their participation in the study or abilityto use the device
  • Eye disease, including but not limited to:
  • Glaucoma (≥ 22 mmHg intraocular pressure)
  • Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsularcataract [any grade using the Lens Opacities Classification System III])
  • Macular degeneration (retinal pigmented epithelium mottling and/or any drusenwithin 500 μm of macula)
  • Eye infection (corneal ulcer, corneal infiltrates, superficial punctatekeratitis)
  • 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 onthe smartphone in the investigator's opinion.

Study Design

Total Participants: 230
Study Start date:
May 07, 2019
Estimated Completion Date:
March 31, 2020

Study 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.

Connect with a study center

  • United Medical Research Institute

    Inglewood, California 90301
    United States

    Site Not Available

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