PurposeThe purpose of this multi-institute, single-group clinical trial was to evaluate the effectiveness and safety of toric orthokeratology lenses for the treatment of patients with combined myopia and astigmatism.MethodsA total of 44 patients were included in this clinical trial. The patients ranged in age from 7 to 49 years, with myopia of -0.75 to -6.0 diopters (D) and astigmatism of 1.25 to 4.0 D. After excluding 21 subjects, 23 subjects (39 eyes) were analyzed after toric orthokeratology lens use. The subjects underwent ophthalmologic examination after 1 day and 1, 2, 3, and 4 weeks of wearing overnight toric orthokeratology lenses.ResultsA total of 19 subjects (31 eyes) completed the trial after five subjects (eight eyes) dropped out. In the patients who completed the study by wearing lenses for 4 weeks, the myopic refractive error decreased significantly by 2.60 ± 2.21 D (p < 0.001), from -3.65 ± 1.62 to -1.05 ± 1.64 D. The astigmatic refractive error were also significantly decreased by 0.63 ± 0.98 D (p = 0.001), from 2.07 ± 0.83 to 1.44 ± 0.99 D. The mean uncorrected and corrected visual acuities before wearing the lenses were 2.14 ± 0.80 logarithm of the logMAR (logMAR) and 0.05 ± 0.13 logMAR, respectively, which changed to 0.12 ± 0.30 logarithm of the logMAR (p < 0.001) and 0.01 ± 0.04 logMAR (p = 0.156) after 4 weeks. No serious adverse reactions were reported during the clinical trial.ConclusionsOur results suggest that toric orthokeratology is an effective and safe treatment for correcting visual acuity in patients with combined myopia and astigmatism.