Refractive ErrorsNCT06044688
EyeQue VisionCheck 510(k) Clinical Trial
A study testing EyeQue VisionCheck and Phoropter in people with Refractive Errors and Astigmatism, run by EyeQue Corp..
Trial summary
Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Astigmatism
- What is being tested?
- EyeQue VisionCheck and Phoropter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each participant must meet the following criteria to be enrolled in this study:
- Participant or legally authorized representative (LAR) is willing and able to give informed consent
- Participant is willing and able to follow all study procedures and requirements
- Participant is able to use a smartphone
- Participant is interested in getting refraction correction measurement
- Participant is able to speak, read and write English fluently
Who cannot join
- Participants who meet any of the following criteria will be excluded from the study:
- Spherical correction >+8D or <-10D (outside the range of the VisionCheck measurement)
- Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement)
- Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device
- Participant does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the Investigator's opinion
- Has initiated any new medication in the two weeks prior to enrolling in this study that, in the best medical judgment of the Investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device
Show all 27Show fewer
- Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement)
- Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect vision within the greater of three days or five half-lives prior to enrolling in this study
- Using an investigational drug or approved therapy for investigational use within the greater of three days or five half-lives prior to enrolling in this study
- Color deficiency (Ishihara pseudoisochromatic plates: Concise 14-plate edition: six or more errors on plates 1-11; the 24-plate edition: seven or more errors on plates 1-15; the 38-plate edition: nine or more errors on plates 1-21)
- Neurological and developmental conditions that may affect the outcome of the trial including, but not limited to, Multiple Sclerosis (MS), Stroke, Traumatic Brain Injury (TBI), Parkinson's Disease, Alzheimer's Disease, Dementia, Migraines, Optic Neuropathies, Brain Tumors, Hereditary Conditions (such as Leber's hereditary optic neuropathy (LHON) or retinitis pigmentosa), Epilepsy, Diplopia. Investigator discretion shall be applied to any additional conditions not listed.
- Eye pathologies, including but not limited to:
- Glaucoma
- Any macular disease including macular degeneration, macular hole, macular dystrophy, epiretinal membrane, retinal vein occlusion, macular telangiectasia, central serous chorioretinopathy and cystoid macular edema
- Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis, ocular histoplasmosis syndrome)
- Keratoconus
- Diabetic neuropathy/retinopathy
- Cytomegalovirus retinitis
- Diabetic macular edema (evidence of fluid)
- Retinitis pigmentosa
- Amblyopia (best corrected visual acuity [BCVA] ≥ 20/30)
- Chronic or acute uveitis (cells and/or flare in the anterior chamber)
- Strabismus (manifest/latent, exotropia, esotropia, hypertropia, exophoria, and esophoria)
- Abnormal astigmatism (mild to severe, > 4D)
- Binocular vision anomalies
- Chronic dry eye
- Monovision
Trial locations and contacts
No sites are listed yet.
About this study
Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.
Read the detailed description
The primary purpose of this study is to attain scientific objective evidence to support the VisionCheck Indications for Use by demonstrating that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits. The Indications for Use are:
"The EyeQue VisionCheck automated subjective refraction system provides an estimate of sphere, cylinder, and axis measurements of the eye"
Furthermore, the purpose of this study is to attain scientific objective evidence regarding the precision of the VisionCheck device.
- Conditions
- Refractive Errors, Astigmatism
- Being tested
- EyeQue VisionCheck, Phoropter
- 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.
EyeQue VisionCheckDevice
Automated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye.
PhoropterDevice
Standard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription.
| Study group | Role | What they receive |
|---|---|---|
| Phoropter | Experimental | Refraction performed by an eye care professional using a phoropter. Receives: Device: Phoropter |
| VisionCheck | Active comparator | Self-administered refraction performed using the EyeQue VisionCheck device. Receives: Device: EyeQue VisionCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement.
Bland-Altman limits of agreement (LoA) for within-eye differences between refraction measurements of sphere, cylinder, and axis obtained from VisionCheck and the subjective phoropter
Measured: 3 months
Assess total variability and variance components for between- replicates (repeatability) and between-device/operator while adjusting for between-participant and between-site variability.
Percent coefficient of variation (%CV) and standard deviation (SD) of refraction measurement outputs in the form of sphere, cylinder, and axis obtained from VisionCheck
Measured: 3 months
Secondary outcomes (2)
Assess improvement in visual acuity brought forth by the VisionCheck refraction measurement.
95% upper prediction limit of improvement in visual acuity from refraction measurements obtained from VisionCheck compared to best corrected visual acuity from the subjective phoropter
Measured: 3 months
Assess the safety of the VisionCheck device.
Adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs), anticipated and unanticipated serious adverse device effects (ASADEs and USADEs, respectively)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044688
- Sponsor's protocol ID
- EYEQUE-011
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EyeQue VisionCheck 510(k) Clinical Trial
- ClinicalTrials.gov ID
- NCT06044688
- Acronym / sponsor ID
- EYEQUE-011
- Conditions
- Refractive Errors, Astigmatism
- Keywords
- Myopia, Hyperopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Collaborators
- The Emmes Company, LLC
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.
Detailed description
The primary purpose of this study is to attain scientific objective evidence to support the VisionCheck Indications for Use by demonstrating that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits. The Indications for Use are:
"The EyeQue VisionCheck automated subjective refraction system provides an estimate of sphere, cylinder, and axis measurements of the eye"
Furthermore, the purpose of this study is to attain scientific objective evidence regarding the precision of the VisionCheck device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phoropter | Experimental | Device: PhoropterRefraction performed by an eye care professional using a phoropter. |
| VisionCheck | Active comparator | Device: EyeQue VisionCheckSelf-administered refraction performed using the EyeQue VisionCheck device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant or legally authorized representative (LAR) is willing and able to give informed consent
- Participant is willing and able to follow all study procedures and requirements
- Participant is able to use a smartphone
- Participant is interested in getting refraction correction measurement
- Participant is able to speak, read and write English fluently
Key exclusion criteria (27 listed)
- Spherical correction >+8D or <-10D (outside the range of the VisionCheck measurement)
- Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement)
- Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device
- Participant does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the Investigator's opinion
- Has initiated any new medication in the two weeks prior to enrolling in this study that, in the best medical judgment of the Investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device
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 |
|---|---|---|
| EyeQue VisionCheckAutomated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye. | Device | VisionCheck |
| PhoropterStandard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription. | Device | Phoropter |
Primary outcome
Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement.
Time frame: 3 months
Bland-Altman limits of agreement (LoA) for within-eye differences between refraction measurements of sphere, cylinder, and axis obtained from VisionCheck and the subjective phoropter
Assess total variability and variance components for between- replicates (repeatability) and between-device/operator while adjusting for between-participant and between-site variability.
Time frame: 3 months
Percent coefficient of variation (%CV) and standard deviation (SD) of refraction measurement outputs in the form of sphere, cylinder, and axis obtained from VisionCheck
2 secondary outcomes
Assess improvement in visual acuity brought forth by the VisionCheck refraction measurement.
Time frame: 3 months
Assess the safety of the VisionCheck device.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing EyeQue VisionCheck and Phoropter in people with Refractive Errors and Astigmatism, run by EyeQue Corp..
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 27 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noam Sapiens, PhD (510-455-8168, noam.sapiens@eyeque.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement. (time frame: 3 months). The study lists 2 primary outcomes in all. 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 21 Sep 2023.