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Completed

NCT Number: NCT03957408

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

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

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EyeQue

Newark, California, 94560, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Visual Stimuli

Device

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

Primary outcomes

  1. Accommodative Response

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

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

Sponsors and collaborators

Lead sponsor

EyeQue Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 21, 2019
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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