- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04321538
Gocheck Kids vs. Welch Allyn Spot Vision Screener
Evaluation of the GoCheck Kids Mobile Vision Screening Application and the Welch Allyn Spot Vision Screener
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The United States Preventive Services Task Force has recommended early screening in children in order to detect vision abnormalities that could result in amblyopia, a condition in which there is abnormal brain development when there is suboptimal vision in one or both eyes. Prior to the introduction of vision screening instruments, physicians would wait to screen children at age 3-4, when they are able to read letter or symbol charts. The introduction of vision screening instruments has provided a screening option for children as young as 6 months.
Photoscreening devices evaluate for amblyopia risk factors, including refractive error (need for glasses), or strabismus (eye misalignment). Since the advent of instrumental vision screening, improvements are continually being made to improve the quality and scope of vision screening devices. As more affordable and convenient instruments are developed to supplement the traditional letter charts used to screen children, there is a need for more prospective trials to test the efficacy of these instruments. Our study is designed to evaluate the latest model of GoCheck Kids iPhone vision screener with the widely-used Welch Allyn Spot Vision Screener. The GoCheck Kids smartphone application is paid for on a monthly basis and includes telephone rental rather than requiring that a device be purchased. This lower upfront cost option will allow for more primary care practices to participate with a decreased upfront financial burden.
Children ages 1 year to less than 7 years referred to a Yale New Haven Hospital and Yale Medicine pediatric ophthalmology practice for a failed vision screen will be prospectively recruited for participation at the time of their already scheduled appointment for a complete eye exam. Following informed consent, each participant will be screened using both the GoCheck Kids smartphone application and the Welch Allyn Spot Vision Screener. Screening for each of these devices involves a process akin to having a photograph taken. Obtaining consent and photo screenings will take less than 5 minutes. The complete eye exam, which will be performed in this referral group regardless of study participation, will include evaluation of the front and back of the eye, eye alignment, and determination of the refractive state by retinoscopy (check if glasses are needed by using a special type of light and handheld lenses). The ability of each screening device to detect amblyopia risk factors when they are present (sensitivity) will be determined by comparison with the detection of amblyopia risk factors during the complete eye exam, which is considered the gold standard.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Martha A Howard, MD
- Phone Number: 203 785-2020
- Email: martha.howard@yale.edu
Study Contact Backup
- Name: Jill C Rotruck, MD
- Phone Number: 203 785-2020
- Email: jill.rotruck@yale.edu
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale New Haven Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children ages 1-<7 years.
Exclusion Criteria:
- Children with a history of ocular surgery and children with ocular conditions or behavior that preclude obtainment of the screening photo images or completion of a complete eye exam.
- Children with an obstructed visual axis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Failed Vision Screen Cohort
This cohort represents the entire group of study participants- children who were referred to Yale New Haven Hospital and Yale Medicine for a failed vision screen by either their primary care provider or their school.
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GoCheck Kids is a photoscreening device.
It takes a special picture of the eyes that allows for detection of refractive error and eye misalignment.
The Welch Allyn Spot Vision Screener is a photoscreening device.
It takes a special picture of the eyes that allows for the detection of refractive error and eye misalignment.
Retinoscopy and an oculomotor testing will constitute the physical examination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivities for amblyopia risk factor detection
Time Frame: Up to 2 hours
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The sensitivity is the percentage of patients with amblyopia whose vision screen indicates they have an amblyopia risk factor.
The sensitivity for the detection of amblyopia risk factors is determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens by the photoscreener (as determined by the gold standard physical exam including cycloplegic retinoscopy to look for refractive error and oculomotor exam to evaluate strabismus) and dividing by the sum of truly positive failed vision screens plus false-negative vision screens (the vision screener did not detect amblyopia risk factors when they were found to be present on the physical exam).
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Up to 2 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity for detection of refractive error
Time Frame: Up to 2 hours
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The refractive error will be determined using the gold standard physical exam technique of cycloplegic retinoscopy.
The sensitivity for the detection of refractive error will be determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens for refractive error and dividing by the sum of truly positive failed vision screens for refractive error plus false-negative vision screens for refractive error.
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Up to 2 hours
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Sensitivity for detection of strabismus
Time Frame: Up to 2 hours
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The presence of strabismus will be determined using an oculomolotor exam.
The sensitivity for the detection of strabismus will be determined individually for both the GoCheck Kids application and the Welch Allyn Spot Vision Screener by calculating the number of truly positive failed vision screens for strabismus and dividing by the sum of truly positive failed vision screens for strabismus plus false-negative vision screens for strabismus.
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Up to 2 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martha A Howard, MD, Yale School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000026666
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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