Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
Primary Purpose
Refractive Errors, Vision Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EQ103
Sponsored by
About this trial
This is an interventional diagnostic trial for Refractive Errors
Eligibility Criteria
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)
Sites / Locations
- EyeQueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Refraction with a Hand-held Refraction Device
Autorefractor
Arm Description
This is the device that will be compared to a standard device.
Standard Device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04693247
Brief Title
Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
June 21, 2023 (Anticipated)
Study Completion Date
June 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeQue Corp.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Vision Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
Tester and subject for BCVA are masked as to which device and trial frames are from.
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Refraction with a Hand-held Refraction Device
Arm Type
Active Comparator
Arm Description
This is the device that will be compared to a standard device.
Arm Title
Autorefractor
Arm Type
Other
Arm Description
Standard Device
Intervention Type
Device
Intervention Name(s)
EQ103
Intervention Description
Refraction device
Primary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings
Description
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
Time Frame
Day 1
Title
Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings
Description
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
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
EyeQue
City
Newark
State/Province
California
ZIP/Postal Code
94560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul TANPIENGCO
Phone
510-455-8168
Email
paul.tanpiengco@eyeque.com
First Name & Middle Initial & Last Name & Degree
Noam Sapiens, PhD
12. IPD Sharing Statement
Learn more about this trial
Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
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