Clinical validation of a multifunction ocular biometer in children.

CLINICAL RELEVANCE Reliable ocular biometry and refraction measurements are essential for monitoring paediatric myopia in routine practice and school screening. Integrated instruments may improve clinical workflow, but measurement differences between devices can influence longitudinal interpretation.

Background

Accurate assessment of biometric and refractive parameters is essential for paediatric myopia management. The aim was to evaluate the agreement and repeatability of a multifunctional ocular biometer, the SW-9000ARK, compared with established instruments for ocular biometry and refraction.

Methods

This prospective cross-sectional study included 361 children (mean age 10.7 ± 2.5 years; 49.0% girls). All subjects underwent non-cycloplegic measurements with the SW-9000ARK, IOLMaster 700, and Topcon KR-800 in random order, followed by subjective refraction (SR). Agreement was assessed using Bland-Altman analysis. Repeatability in 211 right eyes was assessed using within-subject standard deviation, test-retest repeatability, coefficient of variation and intraclass correlation coefficient (ICC).

Results

The SW-9000ARK showed excellent agreement with the IOLMaster 700 for axial length (mean difference -0.01 mm; 95% LoA -0.08 to +0.05 mm), central corneal thickness (+5.19 µm; 95% LoA -9.57 to +19.96 µm), anterior chamber depth (-0.03 mm; 95% LoA -0.11 to +0.05 mm), lens thickness, and keratometry, with ICC values ≥ 0.96. Spherical equivalent exhibited strong agreement with the Topcon KR-800 (+0.08D; 95% LoA -0.65 to +0.81D) and SR (+0.35D; 95% LoA -0.43 to +1.13D). Repeatability was high across all parameters (Sw = 0.018 mm for AL; ICC ≥0.94).

Conclusion

The SW-9000ARK provides highly agreeable and repeatable measurements of ocular biometry and non-cycloplegic refraction in paediatric ametropia, supporting its use as a reliable single-platform tool for myopia management and large-scale screening.