Condition or disease | Intervention/treatment | Phase |
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Refractive Errors Astigmatism | Device: Hand-held device supported by a mobile application Device: Phoropter Device: Autorefractor | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Refraction with a Hand-held Device Supported by Mobile App.
BCVA with handheld device with app.
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Device: Phoropter
Manual refraction and ETDRS chart
Device: Autorefractor Automated refraction
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Active Comparator: Manual Refraction
BCVA with phoropter
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Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
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Active Comparator: Automated Refraction
BCVA with autorefractoer
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Device: Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Eye disease, including but not limited to:
Contact: Carmen Marin | 310-645-4673 | carmen@drjamespeace.com |
United States, California | |
United Medical Research Institute | Recruiting |
Inglewood, California, United States, 90301 |
Principal Investigator: | James Peace, MD | United Medical Research Institute |
Tracking Information | |||||||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | EyeQue Corp. | ||||||||
Study Sponsor ICMJE | EyeQue Corp. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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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 |