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

Sponsor
EyeQue Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT03957408
Collaborator
(none)
38
1
1
15.5
2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Visual Stimuli
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
Actual Study Start Date :
Sep 3, 2019
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Dec 18, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Visual Stimuli

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

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

Outcome Measures

Primary Outcome Measures

  1. Accommodative Response [Through study completion, an average of 5 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 EyeQue Newark California United States 94560

Sponsors and Collaborators

  • EyeQue Corp.

Investigators

  • Principal Investigator: Noam Sapiens, EyeQue Corp.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyeQue Corp.
ClinicalTrials.gov Identifier:
NCT03957408
Other Study ID Numbers:
  • EYEQUE - 002
First Posted:
May 21, 2019
Last Update Posted:
Mar 24, 2021
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 24, 2021