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Status unknownNCT04955379Updated Jan 30, 2023

Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction

An interventional study of EQ103 in Refractive Errors, Accomodation and Diagnostic Self Evaluation, sponsored by EyeQue Corp.. Status unknown at 1 site in Israel. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-30.

Sponsored by EyeQue Corp. · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Refractive Errors
  • Accomodation
  • Diagnostic Self Evaluation

Browse trials for

Keywords

  • Refraction
  • Telehealth
  • Vision
  • Accommodation
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's planned enrollment of 50 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

EyeQue Corp. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Measurements

    Subjects will be tested with the Autorefractor and the EQ103 device

    Device: EQ103

Interventions

  • DeviceEQ103

    Ophthalmic Refractometer with a measurement and background channel

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1 and 14

  2. 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.

    Time frame: Day 1 and 14

  3. 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.

    Time frame: Day 1 and 14

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04955379
Lead sponsor
EyeQue Corp.
Collaborators
Sheba Medical Center
Responsible party
Sponsor
First posted
Jul 8, 2021
Start date
Dec 15, 2021
Primary completion
Jul 31, 2023 (estimated)
Completion
Jul 31, 2023 (estimated)
Last update
Jan 30, 2023

Study contacts

Noam Sapiens, PhD
Contact
noam.sapiens@eyeque.com
(510) 953-6433 ext. 600
Ygal Rotenstreich
Contact
(408) 630-5086
Noam Sapiens, PhD
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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