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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03957408
Other study ID # EYEQUE - 002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2019
Est. completion date December 18, 2020

Study information

Verified date January 2020
Source EyeQue Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 18, 2020
Est. primary completion date December 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States EyeQue Newark California

Sponsors (1)

Lead Sponsor Collaborator
EyeQue Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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