Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

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

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.

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.

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.