Refractive ErrorsNCT03929588
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
A study testing Hand-held device supported by a mobile application, Phoropter and Autorefractor in people with Refractive Errors and Astigmatism, run by EyeQue Corp. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Astigmatism
- What is being tested?
- Hand-held device supported by a mobile application, Phoropter and Autorefractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 31 Mar 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
United Medical Research Institute
Inglewood, California, 90301
About this study
Official title: A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye
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.
Read the 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.
- Conditions
- Refractive Errors, Astigmatism
- Being tested
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Keywords
- myopia, hyperopia
- Medical subject headings
- Refractive Errors, Astigmatism, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-held device supported by a mobile applicationDevice
Hand-held device supported by a mobile application to obtain refractive error of the eye.
PhoropterDevice
Manual refraction and ETDRS chart
AutorefractorDevice
Automated refraction
| Study group | Role | What they receive |
|---|---|---|
| Refraction with a Hand-held Device Supported by Mobile App. | Experimental | BCVA with handheld device with app. Receives: Device: Phoropter; Device: Autorefractor |
| Manual Refraction | Active comparator | BCVA with phoropter Receives: Device: Hand-held device supported by a mobile application |
| Automated Refraction | Active comparator | BCVA with autorefractoer Receives: Device: Hand-held device supported by a mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start7 May 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Peace, MD, Principal investigator, United Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929588
- Sponsor's protocol ID
- EYEQUE - 001
- Status last verified
- Feb 2022
- First submitted
- 22 Apr 2019
- Last updated
- 24 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes