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

Primary Purpose

Refractive Errors, Accomodation, Diagnostic Self Evaluation

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EQ103
Sponsored by
EyeQue Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Refractive Errors focused on measuring Refraction, Telehealth, Vision, Accommodation

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Measurements

Arm Description

Subjects will be tested with the Autorefractor and the EQ103 device

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 28, 2021
Last Updated
January 26, 2023
Sponsor
EyeQue Corp.
Collaborators
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04955379
Brief Title
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeQue Corp.
Collaborators
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Accomodation, Diagnostic Self Evaluation
Keywords
Refraction, Telehealth, Vision, Accommodation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Measurements
Arm Type
Other
Arm Description
Subjects will be tested with the Autorefractor and the EQ103 device
Intervention Type
Device
Intervention Name(s)
EQ103
Intervention Description
Ophthalmic Refractometer with a measurement and background channel
Primary Outcome Measure Information:
Title
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
Description
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
Description
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
Title
EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
Description
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
Title
EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Sapiens, PhD
Phone
(510) 953-6433
Ext
600
Email
noam.sapiens@eyeque.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ygal Rotenstreich
Phone
(408) 630-5086
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Sapiens, PhD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ygal Rotenstreich
Phone
+972-527485888
Email
ygal.rotenstreich@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

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

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