Last updated: February 28, 2022
Sponsor: EyeQue Corp.
Overall Status: Completed
Phase
N/A
Condition
Eye Disorders/infections
Astigmatism
Treatment
N/AClinical Study ID
NCT03929588
EYEQUE - 001
Ages 30-65 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
United Medical Research Institute
Inglewood, California 90301
United StatesSite Not Available

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