Instrument Referral Criteria for PlusoptiX, SPOT and 2WIN Targeting 2021 AAPOS Guidelines

BACKGROUND: The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) issued a 2021 update of Uniform Validation Guidelines for instrument-based pediatric vision screeners. With each update it is important for each manufacturer to update the Instrument Referral Criteria (IRC) programed into their devices in order to optimize sensitivity and specificity to detect AAPOS criteria. METHODS: De-identified data comparing photoscreening with simultaneous confirmatory examinations constituted separate cohorts for the development of IRC via receiver operating characteristic (ROC) curves. The refractions of the devices were also compared. RESULTS: This study defines three sets of refractive IRC (Sensitive, Medium, and Specific) for three leading infrared photoscreening devices, PlusoptiX A12, Welch-Allyn SPOT, and Adaptica 2WIN for children < 4 and ≥ 4 years in order to better target the 2021 AAPOS guidelines. The cohorts were similar but the SPOT group (n=755, mean age 9) was older with more astigmatism and the 2WIN (n=1362, mean age 7) was younger with more hyperopia and anisometropia compared to the cohort for PlusoptiX A12 (n=616, mean age 8). The age-based, medium magnitude IRC for anisometropia, hyperopia, astigmatism and myopia for SPOT were: <4y: 1.5, 1.75, 3.25, 3.5 and ≥4y: 1.5, 1.75, 2.25, 2.0; for PlusoptiX: <4y: 1.75, 3.0, 3.5, 3.5 and ≥4y: 1.75, 3.0, 2.5, 2.5; and for 2WIN: <4y: 1.75, 2.5, 3.5, 3.5 and ≥4y: 1.5, 2.0, 2.5, 2.0. The mean ABCD ellipsoid spectacle matches differed; SPOT: 1.8±1.3 (better) versus PlusoptiX: 1.9±1.6 and 2WIN: 2.2±1.4 (p<0.001). CONCLUSION: The 2021 AAPOS exam guidelines foster early specificity before age 4 and sensitivity after age 4. These evidence-based IRC for current SPOT, PlusoptiX, and 2WIN photoscreeners should allow device manufacturers the data necessary to adjust their device IRC to maximize specificity, sensitivity or a medium between the two. This paper provides practical suggestions for better validation. Improved early screening combined with thorough treatment should reduce life-long vision impairment due to amblyopia.