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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measurements | Other | Subjects will be tested with the Autorefractor and the EQ103 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQ103 | Device | Ophthalmic Refractometer with a measurement and background channel |
|
| 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 |
| 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
| Day 1 and 14 |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noam Sapiens, PhD | Contact | (510) 953-6433 | 600 | noam.sapiens@eyeque.com |
| Ygal Rotenstreich | Contact | (408) 630-5086 |
| Name | Affiliation | Role |
|---|---|---|
| Noam Sapiens, PhD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Tel Litwinsky | 5262100 | Israel |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| 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
| 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
| Day 1 and 14 |