Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Measurements Subjects will be tested with the Autorefractor and the EQ103 device |
Device: EQ103
Ophthalmic Refractometer with a measurement and background channel
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Outcome Measures
Primary Outcome Measures
- 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
- 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 Groups 6 to 12 y.o. >12 to <18 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or Female
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Ages ≥6 y.o. and <18 y.o.
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Binocular vision
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Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
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Subject able to follow all study procedures and requirements
Exclusion Criteria:
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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:
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Cataracts
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Macular degeneration
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Eye infection (by self-report or observation)
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Keratoconus
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Diabetic neuropathy/retinopathy
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Cytomegalovirus retinitis
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Color blindness (any color deficiency)
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Diabetic macular edema
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Amblyopia
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Chronic or acute uveitis
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Strabismus
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Astigmatism > 3 diopters
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- EyeQue Corp.
- Sheba Medical Center
Investigators
- Study Director: Noam Sapiens, PhD, Sponsor GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EYEQUE-005