Gocheck Kids vs. Welch Allyn Spot Vision Screener
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Observational

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.
    

Intervention name(s): Gocheck Kids; Welch Allyn Spot Vision Screener; Physical Exam
Intervention type(s): Device; Device; Diagnostic Test
Intervention description(s): 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.
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.
      
Keywords: GoCheck Kids; Welch Allyn Spot Vision Screener; Vision Screening; Photoscreening