Refractive ErrorsNCT04693247
Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
A study testing EQ103 in people with Refractive Errors and Vision Disorders, run by EyeQue Corp. at 1 site in United States.
Trial summary
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Vision Disorders
- What is being tested?
- EQ103
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 21 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Ages =>18 y.o. and =<65 y.o.
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
Who cannot join
- Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
- Has traveled outside the country within the last 4 weeks.
- At the discretion of the investigator: Age strata has achieved minimum evaluable population.
- 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
Show all 32Show fewer
- 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 EyeQue EQ103 device
- Any self-reported mental illness or condition, including but not limited to:
- claustrophobia, fear of simulators, nyctophobia.
- Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus
- Per subject self-reporting: eye disease, including but not limited to:
- Glaucoma
- Cataracts
- Macular degeneration
- Eye infection (by self-report or observation)
- Keratoconus
- Diabetic neuropathy/retinopathy
- Cytomegalovirus retinitis
- Color blindness (any color deficiency)
- Diabetic macular edema
- Amblyopia
- Chronic or acute uveitis
- Strabismus
- Astigmatism > 3 diopters
- Macular hole
- Subjects that:
- Lack physical dexterity to properly operate the EyeQue device.
- Lack the ability to follow instruction
- Lack a command of the English language
- Lack binocular vision
- Are colorblind
- Had eye surgery within the last 12 months (including Lasik)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
EyeQue
Newark, California, 94560
Paul TANPIENGCO, 510-455-8168, paul.tanpiengco@eyeque.com
Noam Sapiens, PhD
About this study
Official title: An Exploratory Study in Healthy Adult Volunteers to Evaluate the Best Corrected Visual Acuity (BCVA) Performance of a Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
Read the detailed description
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
- Conditions
- Refractive Errors, Vision Disorders
- Being tested
- EQ103
- Medical subject headings
- Refractive Errors, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ103Device
Refraction device
| Study group | Role | What they receive |
|---|---|---|
| Refraction with a Hand-held Refraction Device | Active comparator | This is the device that will be compared to a standard device. Receives: Device: EQ103 |
| Autorefractor | Other | Standard Device Receives: Device: EQ103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants
Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart) for each eye from (pooled) trial frames created with the refraction values compared with those of an autorefractor analyzed with all age groups.
Measured: Day 1
Secondary outcomes (2)
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings
Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for each eye (pooled) from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata.
- Age Groups: 18 - 29, 30 - 44, 45 - 65
Measured: Day 1
Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings
Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for worse eye from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata.
- Age Groups: All, 18 - 29, 30 - 44, 45 - 65
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start28 Oct 2020
- Primary completion21 Jun 2023 (estimated)
- Study completion21 Jun 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693247
- Sponsor's protocol ID
- EYEQUE - 004
- Status last verified
- Aug 2022
- First submitted
- 29 Dec 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study in Healthy Adult Volunteers to Evaluate the Best Corrected Visual Acuity (BCVA) Performance of a Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
- ClinicalTrials.gov ID
- NCT04693247
- Acronym / sponsor ID
- EYEQUE - 004
- Conditions
- Refractive Errors, Vision Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 21 Jun 2023 (estimated)
- First posted
- 5 Jan 2021 (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.
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
Detailed description
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refraction with a Hand-held Refraction Device | Active comparator | Device: EQ103This is the device that will be compared to a standard device. |
| Autorefractor | Other | Device: EQ103Standard Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Ages =>18 y.o. and =<65 y.o.
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
Key exclusion criteria (32 listed)
- Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
- Has traveled outside the country within the last 4 weeks.
- At the discretion of the investigator: Age strata has achieved minimum evaluable population.
- 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
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 |
|---|---|---|
| EQ103Refraction device | Device | Autorefractor, Refraction with a Hand-held Refraction Device |
Primary outcome
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants
Time frame: Day 1
Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart) for each eye from (pooled) trial frames created with the refraction values compared with those of an autorefractor analyzed with all age groups.
2 secondary outcomes
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings
Time frame: Day 1
Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQ103 in people with Refractive Errors and Vision Disorders, 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 5 inclusion and 32 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 22 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants (time frame: Day 1). 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 22 Aug 2022; AzTrials last refreshed its copy on 28 Oct 2026.