NCT03957408

Brief Summary

An investigational study in the control of the user's accommodative state via visual stimuli.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

May 9, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

March 24, 2021

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

May 9, 2019

Last Update Submit

March 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accommodative Response

    Measurement of accommodative response by measuring visual refraction while the subject is viewing various visual stimuli.

    Through study completion, an average of 5 months

Study Arms (1)

Visual Stimuli

EXPERIMENTAL

Participants will be presented various visual stimuli in which accommodative response is measured.

Device: Visual Stimuli

Interventions

Subjects will be presented various visual stimuli and may be asked to perform tasks. Their accommodative response will be measured.

Visual Stimuli

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female
  • Age 18 through 30 years at the time of consent
  • Binocular vision
  • Willing and able to give informed consent and follow all study procedures and requirements
  • Fluent in English

You may not qualify if:

  • Spherical correction \> +4D or \< -5D, astigmatism \< -2.5D.
  • 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 EyeQue devices
  • Reported or observed eye disease or pathology, including but not limited to:
  • Glaucoma
  • Cataracts
  • Macular degeneration
  • Eye infection
  • Keratoconus
  • Diabetic neuropathy/retinopathy
  • Cytomegalovirus retinitis
  • Color blindness (any color deficiency)
  • Diabetic macular edema
  • Amblyopia
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EyeQue

Newark, California, 94560, United States

Location

Study Officials

  • Noam Sapiens

    EyeQue Corp.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 21, 2019

Study Start

September 3, 2019

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

March 24, 2021

Record last verified: 2020-01

Locations