Clinical trial NCT04321538: Gocheck Kids vs. Welch Allyn Spot Vision Screener
Official title: Evaluation of the GoCheck Kids Mobile Vision Screening Application and the Welch Allyn Spot Vision Screener
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Keywords: GoCheck Kids
Welch Allyn Spot Vision Screener
Vision Screening
Photoscreening
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 227
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 1-\<7 years referred to a Yale New Haven Hospital and Yale Medicine associated pediatric ophthalmology practice for a failed vision screen.

Brief summary: The investigators are conducting a prospective evaluation of the ability of two vision photoscreening devices (GoCheck Kids and the Welch Allyn Spot Vision Screener) to detect risk factors for amblyopia. Photoscreeners function similar to having a picture taken with a camera. Amblyopia is decreased vision in one or both eyes due to decreased vision development in the brain resulting from decreased visual stimulation. Children ages 1 year to less than 7 years of age referred to a pediatric ophthalmologist at Yale New Haven Health and Yale Medicine locations for a failed vision screen will be offered participation. The ability of each screening device to detect amblyopia risk factors will be compared with the results of a complete eye exam performed by the practitioner.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivities for amblyopia risk factor detection
timeFrame: Up to 2 hours
Secondary outcomes:
measure: Sensitivity for detection of refractive error
timeFrame: Up to 2 hours
measure: Sensitivity for detection of strabismus
timeFrame: Up to 2 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Martha A Howard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Vision Screening in Children Aged 6 Months to 5 Years: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Sep 5;318(9):836-844. doi: 10.1001/jama.2017.11260.