PURPOSE: The 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. METHODS: A 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. RESULTS: A 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. CONCLUSIONS: Our results suggest that toric orthokeratology is an effective and safe treatment for correcting visual acuity in patients with combined myopia and astigmatism.
Adolescent ; Adult ; Astigmatism/complications/diagnosis/*therapy ; Child ; Cornea/*diagnostic imaging ; Female ; Humans ; Male ; Middle Aged ; Myopia/complications/diagnosis/*therapy ; Orthokeratologic Procedures/*methods ; Slit Lamp Microscopy ; Treatment Outcome ; *Visual Acuity ; Young Adult