Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Refraction with a Hand-held Device Supported by Mobile App. BCVA with handheld device with app. |
Device: Phoropter
Manual refraction and ETDRS chart
Device: Autorefractor
Automated refraction
|
Active Comparator: Manual Refraction BCVA with phoropter |
Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
|
Active Comparator: Automated Refraction BCVA with autorefractoer |
Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
|
Outcome Measures
Primary Outcome Measures
- BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years [Through study completion, an average of 5 months]
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.
Eligibility Criteria
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)
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Cytomegalovirus retinitis
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Color blindness (any color deficiency)
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Diabetic macular edema (evidence of fluid)
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Amblyopia
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Chronic or acute uveitis (cells and/or flare in anterior chamber)
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Strabismus (exotropia, esotropia, and hypertropia)
-
Abnormal astigmatism (mild to severe, > 5 diopters)
-
Macular hole
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | United Medical Research Institute | Inglewood | California | United States | 90301 |
Sponsors and Collaborators
- EyeQue Corp.
Investigators
- Principal Investigator: James Peace, MD, United Medical Research Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- EYEQUE - 001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction |
Period Title: Overall Study | |
STARTED | 230 |
COMPLETED | 143 |
NOT COMPLETED | 87 |
Baseline Characteristics
Arm/Group Title | Refraction With a Hand-held Device Supported by Mobile App. |
---|---|
Arm/Group Description | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction |
Overall Participants | 230 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
230
100%
|
>=65 years |
0
0%
|
Sex: Female, Male (Count of Participants) | |
Female |
115
50%
|
Male |
115
50%
|
Race and Ethnicity Not Collected (Count of Participants) |
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction |
Measure Participants | 143 |
BCVA handheld device |
0.06
|
BCVA manual refraction |
0.02
|
BCVA automated refraction |
0.03
|
Adverse Events
Time Frame | 6 months | |
---|---|---|
Adverse Event Reporting Description | No difference from standard definition. None observed. | |
Arm/Group Title | Refraction With a Hand-held Device Supported by Mobile App. | |
Arm/Group Description | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction | |
All Cause Mortality |
||
Refraction With a Hand-held Device Supported by Mobile App. | ||
Affected / at Risk (%) | # Events | |
Total | 0/230 (0%) | |
Serious Adverse Events |
||
Refraction With a Hand-held Device Supported by Mobile App. | ||
Affected / at Risk (%) | # Events | |
Total | 0/230 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Refraction With a Hand-held Device Supported by Mobile App. | ||
Affected / at Risk (%) | # Events | |
Total | 0/230 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | VP Science and Technology |
---|---|
Organization | EyeQue |
Phone | 5104558168 |
noam.sapiens@eyeque.com |
- EYEQUE - 001