Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
Status unconfirmed · Not applicable
Conditions studied: Refractive Errors, Vision Disorders
In brief
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
Key facts
- Study ID
- NCT04693247
- Run by
- EyeQue Corp.
- People needed
- 35
- Starts
- 2020-10-28
- Expected to finish
- 2023-06-21
- Last updated by the study team
- 2022-08-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or Female
- Ages =>18 y.o. and =<65 y.o.
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
You may not qualify if…
- Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
- Has traveled outside the country within the last 4 weeks.
- At the discretion of the investigator: Age strata has achieved minimum evaluable population.
- 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 EyeQue EQ103 device
- Any self-reported mental illness or condition, including but not limited to:
- claustrophobia, fear of simulators, nyctophobia.
- Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus
- Per subject self-reporting: eye disease, including but not limited to:
- Glaucoma
- Cataracts
- Macular degeneration
- Eye infection (by self-report or observation)
- Keratoconus
- Diabetic neuropathy/retinopathy
- Cytomegalovirus retinitis
- Color blindness (any color deficiency)
- Diabetic macular edema
- Amblyopia
- Chronic or acute uveitis
- Strabismus
- Astigmatism > 3 diopters
- Macular hole
Where it is running
- EyeQue — Newark, California, United States (enrolling)
Full record on ClinicalTrials.gov
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