Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Primary Purpose
Refractive Errors, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand-held device supported by a mobile application
Phoropter
Autorefractor
Sponsored by
About this trial
This is an interventional diagnostic trial for Refractive Errors focused on measuring myopia, hyperopia
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- Age 30 through 65 years at the time of consent
- Binocular vision
- Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
- Willing and able to give informed consent and follow all study procedures and requirements
- Ability to speak and understand the English language
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 device
Eye disease, including but not limited to:
- Glaucoma (≥ 22 mmHg intraocular pressure)
- Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])
- Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
- Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
- Keratoconus
- Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
- Cytomegalovirus retinitis
- Color blindness (any color deficiency)
- Diabetic macular edema (evidence of fluid)
- Amblyopia
- Chronic or acute uveitis (cells and/or flare in anterior chamber)
- Strabismus (exotropia, esotropia, and hypertropia)
- Abnormal astigmatism (mild to severe, > 5 diopters)
- Macular hole
- Eye surgery within the last 12 months (including Lasik or lens replacement)
- Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.
Sites / Locations
- United Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Refraction with a Hand-held Device Supported by Mobile App.
Manual Refraction
Automated Refraction
Arm Description
BCVA with handheld device with app.
BCVA with phoropter
BCVA with autorefractoer
Outcomes
Primary Outcome Measures
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years
Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03929588
Brief Title
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Official Title
A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
Detailed Description
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Astigmatism
Keywords
myopia, hyperopia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Refraction with a Hand-held Device Supported by Mobile App.
Arm Type
Experimental
Arm Description
BCVA with handheld device with app.
Arm Title
Manual Refraction
Arm Type
Active Comparator
Arm Description
BCVA with phoropter
Arm Title
Automated Refraction
Arm Type
Active Comparator
Arm Description
BCVA with autorefractoer
Intervention Type
Device
Intervention Name(s)
Hand-held device supported by a mobile application
Intervention Description
Hand-held device supported by a mobile application to obtain refractive error of the eye.
Intervention Type
Device
Intervention Name(s)
Phoropter
Intervention Description
Manual refraction and ETDRS chart
Intervention Type
Device
Intervention Name(s)
Autorefractor
Intervention Description
Automated refraction
Primary Outcome Measure Information:
Title
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years
Description
Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.
Time Frame
Through study completion, an average of 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female
Age 30 through 65 years at the time of consent
Binocular vision
Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
Willing and able to give informed consent and follow all study procedures and requirements
Ability to speak and understand the English language
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 device
Eye disease, including but not limited to:
Glaucoma (≥ 22 mmHg intraocular pressure)
Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])
Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
Keratoconus
Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
Cytomegalovirus retinitis
Color blindness (any color deficiency)
Diabetic macular edema (evidence of fluid)
Amblyopia
Chronic or acute uveitis (cells and/or flare in anterior chamber)
Strabismus (exotropia, esotropia, and hypertropia)
Abnormal astigmatism (mild to severe, > 5 diopters)
Macular hole
Eye surgery within the last 12 months (including Lasik or lens replacement)
Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Peace, MD
Organizational Affiliation
United Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
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