Clinical trial NCT03929588: 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
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Astigmatism
Keywords: myopia
hyperopia
Lead sponsor: EyeQue Corp.
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 230
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
Study officials:
affiliation: United Medical Research Institute
name: James Peace, MD
role: PRINCIPAL_INVESTIGATOR
References: