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

NCT04693247 | Unknown FDA Device

• 1 other identifier: EYEQUE - 004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractive Errors; Vision Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings

  Day 1

• Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings

  Day 1

Study Arms (2)

Refraction with a Hand-held Refraction Device

ACTIVE COMPARATOR

This is the device that will be compared to a standard device.

Device: EQ103

Autorefractor

OTHER

Standard Device

Device: EQ103

Interventions

EQ103 DEVICE

Refraction device

Autorefractor; Refraction with a Hand-held Refraction Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EyeQue Corp.: lead

Study Sites (1)

EyeQue

Newark, California, 94560, United States

RECRUITING

MeSH Terms

Conditions

Refractive Errors; Vision Disorders

Condition Hierarchy (Ancestors)

Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Tester and subject for BCVA are masked as to which device and trial frames are from.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: October 28, 2020
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

US (1)