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

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.