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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
Show all 21Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03929588
- Acronym / sponsor ID
- EYEQUE - 001
- Conditions
- Refractive Errors, Astigmatism
- Keywords
- myopia, hyperopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 24 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
| Arm | Type | Receives |
|---|---|---|
| Refraction with a Hand-held Device Supported by Mobile App. | Experimental | Device: Phoropter, Device: AutorefractorBCVA with handheld device with app. |
| Manual Refraction | Active comparator | Device: Hand-held device supported by a mobile applicationBCVA with phoropter |
| Automated Refraction | Active comparator | Device: Hand-held device supported by a mobile applicationBCVA with autorefractoer |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-held device supported by a mobile applicationHand-held device supported by a mobile application to obtain refractive error of the eye. | Device | Automated Refraction, Manual Refraction |
| PhoropterManual refraction and ETDRS chart | Device | Refraction with a Hand-held Device Supported by Mobile App. |
| AutorefractorAutomated refraction | Device | Refraction with a Hand-held Device Supported by Mobile App. |
Primary outcome
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Refractive Errors
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Refractive Errors
Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Peace, MD principal investigator
United Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years (time frame: Through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.