Abstract:  Objective To explore the clinical differences between point cloud modeling and simulation calculation-based wavefront-guided objective refraction technology (point cloud wavefront-guided objective refraction) and subjective refraction, and verify the accuracy and efficiency of this novel objective refraction technology. Design A prospective randomized controlled cross-over clinical trial. Participants Sixty-seven adolescents aged 8-18 years with refractive errors were recruited from Beijing Tongren Hospital, between May and June 2025. Participants were excluded if their refractive errors exceeded the device detection range (-10 to +10 diopters [D]), cylinder power >3 D, or had other ocular diseases except refractive errors. Methods The technical framework of point cloud wavefront-guided objective refraction was constructed, including data layer, modeling layer, simulation and optimization layer, and closed-loop feedback layer. Data were collected by Shack-Hartmann aberrometer, and refraction prescriptions were generated through point cloud modeling and surface reconstruction. A randomized controlled cross-over trial was conducted to compare with subjective refraction. Participants wore trial glasses with the two prescriptions successively and completed corrected visual acuity tests. Pearson correlation coefficient, Bland-Altman plots, and paired t-test were used for statistical analysis. Main Outcome Measures Consistency of refraction prescriptions (M, J0, J45 components) and corrected visual acuity. Results There were no significant differences in M (-0.02±0.17)D, J0 (-0.01±0.13) D, and J45 (0.00±0.10) D components between subjective refraction and point cloud wavefront-guided objective refraction (all P>0.05). The 95% confidence intervals for consistency were (-0.35 to 0.31) D for M, (-0.26 to 0.24) D for J0, and (-0.20 to 0.19) D for J45. The difference in corrected visual acuity (0.00±0.05) was not statistically significant (P=0.665). The time consumed by point cloud wavefront-guided objective refraction (26.9±0.17) seconds was significantly shorter than that by subjective refraction (479.1±64.8) seconds (P<0.001). Conclusions The point cloud wavefront-guided objective refraction technology shows high consistency with subjective refraction in prescription and corrected visual acuity, with significantly shorter testing time. It demonstrates remarkable advantages in improving refraction efficiency and visual quality, providing a low-cost and high-precision refraction solution for regions with limited medical resources. 

Key words: Point cloud modeling, Simulation calculation, Wavefront guidance, Subjective refraction, Corrected visual acuity