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出境医 / 临床实验 / Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements

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

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
Accommodation Device: Visual Stimuli Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 3, 2019
Actual Primary Completion Date : December 18, 2020
Actual Study Completion Date : December 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 [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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United States, California
EyeQue
Newark, California, United States, 94560
Sponsors and Collaborators
EyeQue Corp.
Investigators
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Principal Investigator: Noam Sapiens EyeQue Corp.
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date March 24, 2021
Actual Study Start Date  ICMJE September 3, 2019
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
Official Title  ICMJE An Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
Brief Summary An investigational study in the control of the user's accommodative state via 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Accommodation
Intervention  ICMJE Device: Visual Stimuli
Subjects will be presented various visual stimuli and may be asked to perform tasks. Their accommodative response will be measured.
Study Arms  ICMJE Experimental: Visual Stimuli
Participants will be presented various visual stimuli in which accommodative response is measured.
Intervention: Device: Visual Stimuli
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2021) 		38
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2019) 		55
Actual Study Completion Date  ICMJE December 18, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957408
Other Study ID Numbers  ICMJE EYEQUE - 002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EyeQue Corp.
Study Sponsor  ICMJE EyeQue Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Noam Sapiens EyeQue Corp.
PRS Account EyeQue Corp.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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