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

EyeQue

Status: Enrolling

Conditions: Diagnostic Self Evaluation; Accomodation; Refractive Errors

Treatments: Device: EQ103

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04955379

EYEQUE-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Measurements

Other group

Description:

Subjects will be tested with the Autorefractor and the EQ103 device

Treatment:

Device: EQ103