Refractive Errors, Astigmatism
Conditions
Keywords
myopia, hyperopia
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.
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.
Interventions
DEVICEHand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
DEVICEPhoropter
Manual refraction and ETDRS chart
DEVICEAutorefractor
Automated refraction
Sponsors
EyeQue Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Refraction With a Hand-held Device Supported by Mobile App. BCVA with handheld device with app.
Phoropter: Manual refraction and ETDRS chart
Autorefractor: Automated refraction | 230 |
| Total | 230 |
Baseline characteristics
| Characteristic | Refraction With a Hand-held Device Supported by Mobile App. | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 230 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 115 Participants | — |
| Sex: Female, Male Male | 115 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 230 |
| other Total, other adverse events | 0 / 230 |
| serious Total, serious adverse events | 0 / 230 |
Outcome results
Primary
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years
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.
Time frame: Through study completion, an average of 5 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years | BCVA handheld device | 0.06 logMAR |
| All Participants | BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years | BCVA manual refraction | 0.02 logMAR |
| All Participants | BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years | BCVA automated refraction | 0.03 logMAR |