Accomodation, Diagnostic Self Evaluation, Refractive Errors
Conditions
Keywords
Refraction, Telehealth, Vision, Accommodation
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.
Interventions
DEVICEEQ103
Ophthalmic Refractometer with a measurement and background channel
Sponsors
Sheba Medical Center
EyeQue Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Israel
Contacts
Primary ContactNoam Sapiens, PhD
Backup ContactYgal Rotenstreich
Outcome results
None listed