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出境医 / 临床实验 / Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Study Description
Brief Summary:
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.

Condition or disease Intervention/treatment Phase
Refractive Errors Astigmatism Device: Hand-held device supported by a mobile application Device: Phoropter Device: Autorefractor Not Applicable

Detailed Description:
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Refraction with a Hand-held Device Supported by Mobile App.
BCVA with handheld device with app.
 Device: Phoropter
Manual refraction and ETDRS chart

Device: Autorefractor
Automated refraction
Active Comparator: Manual Refraction
BCVA with phoropter
 Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
Active Comparator: Automated Refraction
BCVA with autorefractoer
 Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
Outcome Measures
Primary Outcome Measures :
  1. BVCA utilizing refraction results from handheld device compared to manual refraction methods for the age stratum 45 through 65 years [ Time Frame: Through study completion, an average of 5 months ]
    Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.


Secondary Outcome Measures :
  1. BVCA utilizing refraction results from handheld device compared to automated refraction methods. [ Time Frame: Through study completion, an average of 5 months ]
    BVCA utilizing refraction results using the handheld device with supporting application will be compared to automated refraction methods (using an autorefractor).

  2. Assessing similarity of refraction values from the handheld device compared with the phoropter. [ Time Frame: Through study completion, an average of 5 months ]
    Assessing similarity of refraction values (sphere, cylinder, axis) from the handheld device with supporting application compared with the phoropter through comparative plots and correlations for the age stratum 30 through 65 years and 45 through 65 years.

  3. BVCA utilizing refraction results from handheld device compared to manual refraction methods for the age stratum 30 through 65 years. [ Time Frame: Through study completion, an average of 5 months ]
    BVCA utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 30 through 65 years.

  4. Assessing similarity of refraction values from the handheld device compared with the autorefractor. [ Time Frame: Through study completion, an average of 5 months ]
    Assessing similarity of refraction values (sphere, cylinder, axis) from the handheld device with supporting application compared with the autorefractor through comparative plots and correlations for the age stratum 30 through 65 years and 45 through 65 years.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female
  • Age 30 through 65 years at the time of consent
  • Binocular vision
  • Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
  • Willing and able to give informed consent and follow all study procedures and requirements
  • Ability to speak and understand the English language

Exclusion Criteria:

  • Spherical correction > +8 or < -10
  • 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 the device

  • Eye disease, including but not limited to:

    • Glaucoma (≥ 22 mmHg intraocular pressure)
    • Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])
    • Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
    • Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
    • Keratoconus
    • Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
    • Cytomegalovirus retinitis
    • Color blindness (any color deficiency)
    • Diabetic macular edema (evidence of fluid)
    • Amblyopia
    • Chronic or acute uveitis (cells and/or flare in anterior chamber)
    • Strabismus (exotropia, esotropia, and hypertropia)
    • Abnormal astigmatism (mild to severe, > 5 diopters)
    • 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 device or the on the smartphone in the investigator's opinion.
Contacts and Locations

Contacts
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Contact: Carmen Marin 310-645-4673 carmen@drjamespeace.com

Locations
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United States, California
United Medical Research Institute Recruiting
Inglewood, California, United States, 90301
Sponsors and Collaborators
EyeQue Corp.
Investigators
Layout table for investigator information
Principal Investigator: James Peace, MD United Medical Research Institute
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date November 21, 2019
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019) 		BVCA utilizing refraction results from handheld device compared to manual refraction methods for the age stratum 45 through 65 years [ Time Frame: Through study completion, an average of 5 months ]
Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • BVCA utilizing refraction results from handheld device compared to automated refraction methods. [ Time Frame: Through study completion, an average of 5 months ]
    BVCA utilizing refraction results using the handheld device with supporting application will be compared to automated refraction methods (using an autorefractor).
  • Assessing similarity of refraction values from the handheld device compared with the phoropter. [ Time Frame: Through study completion, an average of 5 months ]
    Assessing similarity of refraction values (sphere, cylinder, axis) from the handheld device with supporting application compared with the phoropter through comparative plots and correlations for the age stratum 30 through 65 years and 45 through 65 years.
  • BVCA utilizing refraction results from handheld device compared to manual refraction methods for the age stratum 30 through 65 years. [ Time Frame: Through study completion, an average of 5 months ]
    BVCA utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 30 through 65 years.
  • Assessing similarity of refraction values from the handheld device compared with the autorefractor. [ Time Frame: Through study completion, an average of 5 months ]
    Assessing similarity of refraction values (sphere, cylinder, axis) from the handheld device with supporting application compared with the autorefractor through comparative plots and correlations for the age stratum 30 through 65 years and 45 through 65 years.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Official Title  ICMJE A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye
Brief Summary Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
Detailed Description Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Refractive Errors
  • Astigmatism
Intervention  ICMJE
  • Device: Hand-held device supported by a mobile application
    Hand-held device supported by a mobile application to obtain refractive error of the eye.
  • Device: Phoropter
    Manual refraction and ETDRS chart
  • Device: Autorefractor
    Automated refraction
Study Arms  ICMJE
  • Experimental: Refraction with a Hand-held Device Supported by Mobile App.
    BCVA with handheld device with app.
    Interventions:
    • Device: Phoropter
    • Device: Autorefractor
  • Active Comparator: Manual Refraction
    BCVA with phoropter
    Intervention: Device: Hand-held device supported by a mobile application
  • Active Comparator: Automated Refraction
    BCVA with autorefractoer
    Intervention: Device: Hand-held device supported by a mobile application
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female
  • Age 30 through 65 years at the time of consent
  • Binocular vision
  • Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
  • Willing and able to give informed consent and follow all study procedures and requirements
  • Ability to speak and understand the English language

Exclusion Criteria:

  • Spherical correction > +8 or < -10
  • 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 the device

  • Eye disease, including but not limited to:

    • Glaucoma (≥ 22 mmHg intraocular pressure)
    • Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])
    • Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
    • Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
    • Keratoconus
    • Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
    • Cytomegalovirus retinitis
    • Color blindness (any color deficiency)
    • Diabetic macular edema (evidence of fluid)
    • Amblyopia
    • Chronic or acute uveitis (cells and/or flare in anterior chamber)
    • Strabismus (exotropia, esotropia, and hypertropia)
    • Abnormal astigmatism (mild to severe, > 5 diopters)
    • 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 device or the on the smartphone in the investigator's opinion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Carmen Marin 310-645-4673 carmen@drjamespeace.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929588
Other Study ID Numbers  ICMJE EYEQUE - 001
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EyeQue Corp.
Study Sponsor  ICMJE EyeQue Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Peace, MD United Medical Research Institute
PRS Account EyeQue Corp.
Verification Date August 2019

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

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