Abstract
To review the published literature on the diagnostic accuracy of instrument-based screening devices used to detect amblyopia and amblyopia risk factors (ARFs).
A literature search of the PubMed database with no date restrictions and limited to articles published in English was last conducted in January 2025. The search yielded 291 articles; 41 were reviewed in full text, and 33 met the criteria for inclusion in this assessment. The panel methodologist assigned a level of evidence rating to each of the included studies.
All 33 articles (which reported results from 28 072 children) were rated level III. Nine screening devices were discussed in the included studies; the most common were the Plusoptix, Spot, and Retinomax. Results from 28 072 children were reported, and most studies focused on children aged 6 years and younger. The most common study setting was ophthalmology clinics, followed by school-based settings and then community-based settings. For detecting ARFs, sensitivity ranged from 32.3% to 100% and specificity ranged from 38.7% to 94% (Plusoptix sensitivity 32.3%-100%, specificity 38.7%-100%; Retinomax sensitivity 70%-95%, specificity 58%-94%; Spot sensitivity 60%-94%, specificity 67%-97%). Examination failure thresholds varied, but most studies after 2013 followed the 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS) guidelines. For the 21 studies that reported the referral rate (percentage of children who failed based on the screening result), the rate varied significantly (2.26%-63%). Higher referral rates were seen in studies based in ophthalmology clinics.
The best available evidence supports the use of instrument-based screening devices to detect amblyopia and ARFs, although there were high levels of variability in the study design, setting, and target age for screening. Additionally, diagnostic accuracy varied on the basis of the screening device used. Future studies of instrument-based screening devices would benefit from following standardized reporting measures for diagnostic accuracy, which will strengthen the evidence base and provide more complete data on which to base decisions about the most appropriate screening programs and strategies.
Proprietary or commercial disclosure may be found after the references.