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Updated: Oct 1, 2025

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

Robert Arnold1, David Silbert2, Heather Modjesky2

  • 1Alaska Blind Child Discovery, Alaska Children's Eye & Strabismus, Anchorage, Alaska, USA.

Clinical Ophthalmology (Auckland, N.Z.)
|March 7, 2022
PubMed
Summary
This summary is machine-generated.

New Instrument Referral Criteria (IRC) for pediatric vision screeners align with 2021 AAPOS guidelines. This study provides data for manufacturers to optimize device sensitivity and specificity for early amblyopia detection.

Keywords:
amblyopiaamblyopia risk factorsinfrared autorefractorrefractionvision screeningvisually significant refractive errors

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Area of Science:

  • Ophthalmology
  • Pediatric Vision Screening
  • Medical Device Validation

Background:

  • The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) released updated 2021 guidelines for validating instrument-based pediatric vision screeners.
  • Manufacturers must update device algorithms, specifically Instrument Referral Criteria (IRC), to meet new sensitivity and specificity standards.

Purpose of the Study:

  • To develop and define age-based refractive IRC for three leading infrared photoscreening devices (SPOT, PlusoptiX, 2WIN).
  • To align device capabilities with the 2021 AAPOS guidelines for improved pediatric vision screening.

Main Methods:

  • Utilized de-identified data from photoscreening and simultaneous confirmatory examinations to develop IRC using receiver operating characteristic (ROC) curves.
  • Compared refractions measured by the devices.

Main Results:

  • Defined three sets of refractive IRC (Sensitive, Medium, Specific) for SPOT, PlusoptiX, and 2WIN devices, stratified by age (<4 years and ≥4 years).
  • Observed variations in cohort characteristics (age, refractive error prevalence) among the three devices.
  • Reported age-based, medium magnitude IRC values for anisometropia, hyperopia, astigmatism, and myopia for each device.

Conclusions:

  • The developed IRC support the 2021 AAPOS guidelines, emphasizing early specificity (<4 years) and sensitivity (≥4 years).
  • This evidence-based data enables manufacturers to adjust device IRC for optimal performance (specificity, sensitivity, or a balance).
  • Improved early screening and treatment are crucial for reducing lifelong vision impairment from amblyopia.