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

Sponsor
EyeQue Corp. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04955379
Collaborator
Sheba Medical Center (Other)
50
Enrollment
1
Arm
9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: EQ103
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Aug 15, 2021
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Measurements

Subjects will be tested with the Autorefractor and the EQ103 device

Device: EQ103
Ophthalmic Refractometer with a measurement and background channel

Outcome Measures

Primary Outcome Measures

  1. Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic) [Day 1]

    Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)

Secondary Outcome Measures

  1. EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata. [Day 1 and 14]

    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.

  2. EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata. [Day 1 and 14]

    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.

  3. EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata. [Day 1 and 14]

    EQ103 without cycloplegia will be compared to EQ103 with cycloplegia in the following age-strata. Age Group 6 to 12 y.o.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • EyeQue Corp.
  • Sheba Medical Center

Investigators

  • Study Director: Noam Sapiens, PhD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyeQue Corp.
ClinicalTrials.gov Identifier:
NCT04955379
Other Study ID Numbers:
  • EYEQUE-005
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by EyeQue Corp.
Refraction
Telehealth
Vision
Accommodation
Additional relevant MeSH terms:
Refractive Errors

Study Results

No Results Posted as of Jul 8, 2021