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Published on: September 16, 2025
Accuracy of Two Novel Self-Contained Darkroom Refractive Screeners Compared with Cycloplegic Retinoscopy and a
Junda Jiang1,2, Rui Yang1, Yuqi Guo1
1Visual Science and Optometry Center, The People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi Key Laboratory of Eye Health, Guangxi Health Commission Key Laboratory of Ophthalmology and Related Systemic Diseases Artificial Intelligence Screening Technology, Institute of Ophthalmic Diseases, Guangxi Academy of Medical Sciences, Nanning, Guangxi, 530022, People's Republic of China.
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.
