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CompletedNCT03957408Updated Mar 24, 2021

Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements

An interventional study of Visual Stimuli in Accommodation, sponsored by EyeQue Corp.. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by EyeQue Corp. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 30 Years
Sex
All
01

Study summary

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

Read the detailed description

The EyeQue Corporation (EyeQue) is developing devices to measure refraction that can be used outside of the clinic. The refraction devices require the user to perform a series of tests while looking through it to view a visual display. The current devices do not currently account for accommodation and therefore may present inaccurate results for the younger population where the accommodation effect is quite significant. This study is aimed at enabling future EyeQue refraction measurement products to overcome this issue and provide the required tools to allow for accommodation measurement, correction and control. Control of the user's accommodative state will allow for measurement of near vision as well as far vision based on the refractive measurement.

02

Conditions studied

  • Accommodation
03

In context

Lead sponsor

EyeQue Corp. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
    • Chronic or acute uveitis (cells and/or flare in anterior chamber)
    • Strabismus (exotropia, esotropia, and hypertropia)
    • Macular hole
  • Eye surgery within the last 12 months (including Lasik or lens replacement)
  • Subject does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the investigator's opinion
  • PD smaller than 50mm or larger than 75mm.
  • Any self-reported mental illness or condition, including but not limited to: claustrophobia, fear of simulators, nyctophobia.
  • Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Visual Stimuli

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

    Device: Visual Stimuli

Interventions

  • DeviceVisual Stimuli

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

06

What researchers measure

Primary outcomes

  1. Accommodative Response

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

    Time frame: Through study completion, an average of 5 months

07

Study locations

1 site
  • EyeQue
    Newark, California 94560, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03957408
Lead sponsor
EyeQue Corp.
Responsible party
Sponsor
First posted
May 21, 2019
Start date
Sep 3, 2019
Primary completion
Dec 18, 2020
Completion
Dec 18, 2020
Last update
Mar 24, 2021

Study contacts

Noam Sapiens
principal investigator · EyeQue Corp.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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