Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

Refractive Errors Clinical Trial

Official title:

An Exploratory Study in Healthy Adult Volunteers to Evaluate the Best Corrected Visual Acuity (BCVA) Performance of a Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693247
• Other study ID #: EYEQUE - 004
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: June 21, 2023

Study information

• Verified date: August 2022
• Source: EyeQue Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

Description:

This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or Female

• Ages =>18 y.o. and =<65 y.o.

• Binocular vision

• Willing and able to give informed consent and follow all study procedures and requirements

• Fluent in English

Exclusion Criteria:

• Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.

• Has traveled outside the country within the last 4 weeks.

• At the discretion of the investigator: Age strata has achieved minimum evaluable population.

• 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-reported mental illness or condition, including but not limited to:

claustrophobia, fear of simulators, nyctophobia.

• Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus

Per subject self-reporting: eye disease, including but not limited to:

• Glaucoma

• 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

Subjects that:

• Lack physical dexterity to properly operate the EyeQue device.

• Lack the ability to follow instruction

• Lack a command of the English language

• Lack binocular vision

• Are colorblind

• Had eye surgery within the last 12 months (including Lasik)

Related Conditions & MeSH terms

• Refractive Errors
• Vision Disorders

Intervention

Device:
• EQ103
Refraction device

Locations

Country	Name	City	State
United States	EyeQue	Newark	California

Sponsors (1)

Lead Sponsor	Collaborator
EyeQue Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants	Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart) for each eye from (pooled) trial frames created with the refraction values compared with those of an autorefractor analyzed with all age groups.	Day 1
Secondary	Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings	Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for each eye (pooled) from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata.; o Age Groups: 18 - 29, 30 - 44, 45 - 65	Day 1
Secondary	Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings	Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart for worse eye from trial frames created with the refraction values compared with those of an autorefractor analyzed within the following age strata.; o Age Groups: All, 18 - 29, 30 - 44, 45 - 65	Day 1