Refractive Errors Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Tel HaShomer |
Lead Sponsor | Collaborator |
---|---|
EyeQue Corp. | Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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