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

Refractive Errors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955379
• Other study ID #: EYEQUE-005
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2023
• Source: EyeQue Corp.
• Contact: Noam Sapiens, PhD
• Phone: (510) 953-6433
• Email: noam.sapiens[@]eyeque.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Accomodation
• Diagnostic Self Evaluation
• Refractive Errors

Intervention

Device:
• EQ103
Ophthalmic Refractometer with a measurement and background channel

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (2)

Lead Sponsor	Collaborator
EyeQue Corp.	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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