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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Refractive Errors, Accomodation, Diagnostic Self Evaluation

Intervention / Treatment
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* Device: EQ103


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Measurements<br>Subjects will be tested with the Autorefractor and the EQ103 device | Device: EQ103<br>* Ophthalmic Refractometer with a measurement and background channel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic) | Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata. | EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed in the following age-strata. Age Groups 6 to 12 y.o. >12 to <18 y.o. | Day 1 and 14 | 
| EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata. | EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed in the following age-strata. Age Group 6 to 12 y.o. | Day 1 and 14 | 
| EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata. | EQ103 without cycloplegia will be compared to EQ103 with cycloplegia in the following age-strata. Age Group 6 to 12 y.o. | Day 1 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refraction, Telehealth, Vision, Accommodation