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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Accomodation; Diagnostic Self Evaluation
• Intervention / Treatment: Device: EQ103

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noam Sapiens, PhD; Phone Number: 600 (510) 953-6433; Email: noam.sapiens@eyeque.com
• Study Contact Backup: Name: Ygal Rotenstreich; Phone Number: (408) 630-5086

Study Locations

• Israel
  • Tel HaShomer, Israel, 5262100
    • Recruiting
    • Sheba Medical Center
    • Contact: Ygal Rotenstreich; Phone Number: +972-527485888; Email: ygal.rotenstreich@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 1 and 14

Collaborators and Investigators

• Sponsor: EyeQue Corp.
• Collaborators: Sheba Medical Center
• Investigators: Study Director: Noam Sapiens, PhD, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Telehealth; Vision; Refraction; Accommodation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EYEQUE-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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