N/A
Completed N=230
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Refractive Errors · Astigmatism
Source: ClinicalTrials.gov NCT03929588 ↗
Enrolled (actual)
230
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years — 0.06; 0.02; 0.03 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years |
0.06; 0.02; 0.03 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03929588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.