Purpose: This study aimed to evaluate the diagnostic accuracy of a novel shape index, the Pentacam Random Forest Index (PRFI), in detecting keratoconus (KC), specifically subclinical keratoconus, in Chinese refractive surgery candidates. Methods: This prospective cohort study included 856 participants who were divided into four groups based on their tomographic outcomes: the KC group (n = 137), the very asymmetric ectasia (VAE) group (n = 73), the normal cornea group (n = 363) and the tomographically suspected KC (TSK) group (n = 283). The diagnostic performance of PRFI and other widely used indices, including the shape index BAD-D and the combined index TBI, was assessed using receiver operating characteristic (ROC) curve analysis and compared using DeLong's test. The area under the curve (AUC), best cutoff values, and Youden index for each parameter are reported. Additionally, the false-positive rates of BAD-D and PRFI were calculated and compared in "normal corneas". Results: All shape and biomechanical parameters collected in this study were found to be significantly different among the four groups (KC, VAE, TSK, and normal groups; p = 0.000). The AUC of PRFI was the highest in detecting any form of KC (including clinical KC eyes and VAE-NT eyes) in Chinese refractive surgery candidates, outperforming the widely used shape index BAD-D (0.919 vs. 0.890, p < 0.001). There was no significant difference in performance between the PRFI and the combined TBI index (0.919 vs. 0.916, p > 0.05). For detecting subclinical KC eyes (i.e., VAE-NT), the AUC of PRFI was 0.774, which was statistically comparable to TBI (0.774 vs. 0.776, p > 0.05), while outperforming BAD-D (0.774 vs. 0.684, p < 0.001). The best cutoff values of PRFI for detecting any KC and VAE-NT eyes were determined to be 0.37 and 0.27, respectively. Additionally, PRFI demonstrated a lower false-positive rate than BAD-D (13.8% vs. 43.8%, p < 0.001). Notably, the relatively high false-positive rate of BAD-D observed in this study might be attributed to the smaller horizontal corneal diameter in tomographically suspected eyes. Conclusions: The PRFI proved to be a superior shape index compared to BAD-D in detecting any form of keratoconus, including subclinical cases, in Chinese refractive surgery candidates. This finding may be attributed to the relatively small corneas commonly observed in Asians.
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