Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
- Conditions
- Refractive ErrorsAccomodationDiagnostic Self Evaluation
- Interventions
- Device: EQ103
- Registration Number
- NCT04955379
- Lead Sponsor
- EyeQue Corp.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
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Spherical correction > +8 or < -10
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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.
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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.
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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,
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Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.
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Any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus.
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Any self/caregiver-reported glaucoma diagnosis of the subject.
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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
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Lack physical dexterity to properly operate the EyeQue device.
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Lack the ability to follow instruction.
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Lack binocular vision.
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Are colorblind.
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Had eye surgery within the last 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Measurements EQ103 Subjects will be tested with the Autorefractor and the EQ103 device
- Primary Outcome Measures
Name Time Method Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic) Day 1 Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
- Secondary Outcome Measures
Name Time Method EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata. Day 1 and 14 EQ103 without cycloplegia will be compared to EQ103 with cycloplegia in the following age-strata.
Age Group
* 6 to 12 y.o.EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata. Day 1 and 14 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.
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Tel HaShomer, Israel