Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction

An Exploratory Study in Healthy Pediatric Volunteers to Evaluate the Performance of a Handheld Device Compared With Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.

This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in the age stratum of 6 through 17 years.

Inclusion Criteria:

• Male or Female
• Ages ≥6 y.o. and <18 y.o.
• Binocular vision
• Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
• Subject able to follow all study procedures and requirements

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 EyeQue EQ103 device,

• Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.

• Any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus.

• Any self/caregiver-reported glaucoma diagnosis of the subject.

• Eye disease, including but not limited to:

  • Cataracts
  • Macular degeneration
  • Eye infection (by self-report or observation)
  • Keratoconus
  • Diabetic neuropathy/retinopathy
  • Cytomegalovirus retinitis
  • Color blindness (any color deficiency)
  • Diabetic macular edema
  • Amblyopia
  • Chronic or acute uveitis
  • Strabismus
  • Astigmatism > 3 diopters
  • Macular hole

• Lack physical dexterity to properly operate the EyeQue device.

• Lack the ability to follow instruction.

• Lack binocular vision.

• Are colorblind.

• Had eye surgery within the last 12 months.