Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening
Condition: Amblyopia; Strabismus
MeSH terms: Amblyopia; Strabismus
Study type: Observational

Summary: 
      Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that
      combine as the leading causes of preventable vision loss in children. They are irreversible
      if not detected and corrected by the age of seven, however half of all cases are missed
      because the conditions do not always manifest themselves and pediatricians are unable to
      reliably detect the conditions. The current health care system badly needs an accurate and
      effective approach toward detecting amblyopia and strabismus in preschool children.

      The study will be conducted in busy, ethnically and racially diverse primary care sites
      operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric
      Vision Scanner with outcomes the current standard of care.
    

Detailed description: 
      After demonstrating feasibility, we will recruit 300 clinical trial participants during
      previously scheduled visits at two Kaiser Permanente of Southern California (KPSC) pediatric
      clinics. We will also send letters and placed phone calls to parents of eligible children who
      lived in cities proximal to the two clinics. Children will be considered eligible if age is ≥
      2 years old, less than 6 years old; have never visited an ophthalmologist (as this could
      indicate a pre-existing eye condition and/or introduce biased eye exam results if the
      physician had seen the patient before), are an active Kaiser Permanente member, and do not
      have a cognitive and/or developmental disability (ICD-10 codes Z82.79 and F84.0).

      Interested participants will either visit an on-site ophthalmology clinic immediately
      following their pediatric visit or make a future appointment at one of two KPSC ophthalmology
      clinics. All study activities will be completed during one appointment. Research staff
      describe the study to parents and obtain informed consent, collected parent-reported
      demographic data about each participant, screen each participant using the PVS, and
      documented PVS results, test acquisition time, and participant cooperation. Testing will be
      performed in a dimly lit room with the child seated on a chair or parents lap. Per
      manufacturer recommendations, a background calibration measurement is first obtained off of
      the face with closed eyes. Then the child is asked to open both eyes and fixate on the smiley
      face target within the device while the binocular retinal polarization scan is performed. PVS
      results will be interpreted as either "pass" or "refer" based on manufacturer
      recommendations. Acquisition time is defined as time from when the research staff picked up
      the PVS to when the result is generated, and cooperation is defined as "excellent" or "fair"
      based on staff discretion (e.g., a patient who listens to instructions and completes the exam
      on the first try would be "excellent," whereas a patient who moves his/her head around during
      testing would be "fair"). A pediatric ophthalmologist masked to the PVS result then performs
      a gold standard eye examination. Possible gold standard examination results were "normal",
      "normal with risk factors" (Table Amblyopia Risk Factors - see protocol), "suspected
      binocular vision deficit," "suspected amblyopia," "amblyopia, "strabismus" and "amblyopia and
      strabismus." (Diagnostic Categories Rubric - see protocol). Results were mutually exclusive.
      To compare the PVS results to the gold standard eye examination among the 300 children
      eligible for analysis, we will perform a validation characteristics analysis with a 95%
      confidence interval (CI).
    

Intervention name(s): Pediatric Vision Scanning device; Reference examination
Intervention type(s): Device; Other
Intervention description(s): The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.; Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
Other intervention name(s): Gold-standard eye exam
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 2-5 who present themselves to the pediatric clinic for well-visits.