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

An 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.

Study Overview

• Status: Completed
• Conditions: Accommodation
• Intervention / Treatment: Device: Visual Stimuli

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newark, California, United States, 94560
      • EyeQue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: EyeQue Corp.
• Investigators: Principal Investigator: Noam Sapiens, EyeQue Corp.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EYEQUE - 002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No