Accuracy of Two Novel Self-Contained Darkroom Refractive Screeners Compared with Cycloplegic Retinoscopy and a Traditional Autorefractor in Schoolchildren.

OBJECTIVE

To evaluate the clinical performance of two novel self-contained darkroom refractive screeners (Columba 300, YD-SX-A) and a traditional tabletop autorefractor (Topcon KR8800) in refractive screening for children and adolescents, using cycloplegic retinoscopy (CR) as the gold standard, and to provide evidence for equipment selection.

METHODS

A total of 1354 participants aged 6-18 years were enrolled from December 2025 to February 2026. Non-cycloplegic measurements were performed sequentially with the three devices, followed by CR after cycloplegia with 0.5% tropicamide. Statistical analyses included Wilcoxon signed-rank test, Bland-Altman analysis, linear regression, and ROC curve analysis.

RESULTS

The prevalence of myopia, hyperopia, and astigmatism measured by CR was 73.2%, 15.0%, and 35.8%, respectively. All three devices showed strong positive correlation with CR in spherical equivalent (SE, r > 0.9), with Topcon KR8800 presenting the optimal correlation and consistency. YD-SX-A had the smallest mean difference in cylinder power with CR. All devices achieved excellent myopia diagnostic efficacy (AUC > 0.95), while Topcon KR8800 was superior in hyperopia and astigmatism diagnosis.

CONCLUSION

Topcon KR8800 has the highest accuracy for clinical precise screening. Columba 300 and YD-SX-A are portable, rapid, and sensitive for myopia screening, suitable for large-scale preliminary screening. A two-level "initial screening-confirmation" process is recommended for myopia prevention and control in children and adolescents.