Refractive ErrorsNCT04955379
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
A study testing EQ103 in people with Refractive Errors and Accomodation, run by EyeQue Corp. at 1 site in Israel.
Trial summary
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- What is being tested?
- EQ103
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Dec 2021to 31 Jul 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or Female
- Ages ≥6 y.o. and <18 y.o.
- Binocular vision
- Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
- Subject able to follow all study procedures and requirements
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 EyeQue EQ103 device,
- Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.
- Any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus.
Show all 26Show fewer
- Any self/caregiver-reported glaucoma diagnosis of the subject.
- Eye disease, including but not limited to:
- 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
- Lack physical dexterity to properly operate the EyeQue device.
- Lack the ability to follow instruction.
- Lack binocular vision.
- Are colorblind.
- Had eye surgery within the last 12 months.
Trial locations and contacts
1 site in 1 country.
Ygal Rotenstreich contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 5262100
Ygal Rotenstreich, +972-527485888, ygal.rotenstreich@sheba.health.gov.il
About this study
Official title: An Exploratory Study in Healthy Pediatric Volunteers to Evaluate the Performance of a Handheld Device Compared With Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
Read the detailed description
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in the age stratum of 6 through 17 years.
- Conditions
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- Being tested
- EQ103
- Keywords
- Refraction, Telehealth, Vision, Accommodation
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ103Device
Ophthalmic Refractometer with a measurement and background channel
| Study group | Role | What they receive |
|---|---|---|
| Measurements | Other | Subjects will be tested with the Autorefractor and the EQ103 device Receives: Device: EQ103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
Measured: Day 1
Secondary outcomes (3)
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed in the following age-strata.
Age Groups
- 6 to 12 y.o. >12 to <18 y.o.
Measured: Day 1 and 14
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed in the following age-strata.
Age Group
- 6 to 12 y.o.
Measured: Day 1 and 14
EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.
EQ103 without cycloplegia will be compared to EQ103 with cycloplegia in the following age-strata.
Age Group
- 6 to 12 y.o.
Measured: Day 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start15 Dec 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Noam Sapiens, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955379
- Sponsor's protocol ID
- EYEQUE-005
- Status last verified
- Jan 2023
- First submitted
- 28 Jun 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study in Healthy Pediatric Volunteers to Evaluate the Performance of a Handheld Device Compared With Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
- ClinicalTrials.gov ID
- NCT04955379
- Acronym / sponsor ID
- EYEQUE-005
- Conditions
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- Keywords
- Refraction, Telehealth, Vision, Accommodation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 8 Jul 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 refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
Detailed description
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in the age stratum of 6 through 17 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurements | Other | Device: EQ103Subjects will be tested with the Autorefractor and the EQ103 device |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or Female
- Ages ≥6 y.o. and <18 y.o.
- Binocular vision
- Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
- Subject able to follow all study procedures and requirements
Key exclusion criteria (26 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 EyeQue EQ103 device,
- Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.
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 |
|---|---|---|
| EQ103Ophthalmic Refractometer with a measurement and background channel | Device | Measurements |
Primary outcome
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
Time frame: Day 1
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
3 secondary outcomes
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
Time frame: Day 1 and 14
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
Time frame: Day 1 and 14
EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.
Time frame: Day 1 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Refractive Errors
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Ygal Rotenstreich contact
Noam Sapiens, PhD study director
Sponsor GmbH
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 Accomodation, run by EyeQue Corp. at 1 site in Israel.
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 26 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 30 Jan 2023. 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 Israel. 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?
Contact Noam Sapiens, PhD ((510) 953-6433 ext. 600, noam.sapiens@eyeque.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic) (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 30 Jan 2023.