Clinical trial NCT04955379: Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractive Errors
Accomodation
Diagnostic Self Evaluation
Keywords: Refraction
Telehealth
Vision
Accommodation
Lead sponsor: EyeQue Corp.
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2021-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
timeFrame: Day 1
Secondary outcomes:
measure: EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
timeFrame: Day 1 and 14
measure: EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.
timeFrame: Day 1 and 14
measure: EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.
timeFrame: Day 1 and 14
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sponsor GmbH
name: Noam Sapiens, PhD
role: STUDY_DIRECTOR
References: