NCT04955379

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

June 28, 2021

Last Update Submit

January 26, 2023

Conditions

Refractive ErrorsAccomodationDiagnostic Self Evaluation

Keywords

RefractionTelehealthVisionAccommodation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 by age-strata.

    Day 1 and 14

  • EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.

    Day 1 and 14

Study Arms (1)

Measurements

OTHER

Subjects will be tested with the Autorefractor and the EQ103 device

Device: EQ103

Interventions

EQ103DEVICE

Ophthalmic Refractometer with a measurement and background channel

Measurements

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 5262100, Israel

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Noam Sapiens, PhD

    Sponsor GmbH

    STUDY DIRECTOR

Central Study Contacts

Noam Sapiens, PhD

CONTACT

(510) 953-6433noam.sapiens@eyeque.com

Ygal Rotenstreich

CONTACT

(408) 630-5086

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 8, 2021

Study Start

December 15, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)