Abstract

This prospective multicenter study evaluated the safety and clinical performance of ultra-high Dk (180 ISO/Fatt) Tisilfocon A orthokeratology (Ortho-K) lenses to treat myopia. We enrolled 67 participants aged 8–49 years with myopia up to 8.00 D. Participants were followed for 36 weeks to assess uncorrected visual acuity (UCVA), axial length (AL), and corneal endothelial cell density (ECD). From the first week, UCVA significantly improved and remained stable through week 36. AL elongation was statistically significant overall, driven primarily by age-appropriate physiological growth in younger participants; adults and individuals with high myopia showed no significant axial elongation. Safety evaluations showed high biocompatibility with no adverse events exceeding Grade 2 corneal staining. ECD remained stable after 36 weeks of lens wear, demonstrating that the ultra-high oxygen permeability of Tisilfocon A supports corneal health and prevents hypoxic stress during overnight wear. Overall, these findings suggest that ultra-high Dk Tisilfocon A Ortho-K lenses are a safe and effective clinical solution for myopia management across diverse patients, providing long-term corneal integrity and stable visual outcomes. ECD remained stable over the 36-week observation period, providing reassuring short- to mid-term evidence that the ultra-high oxygen permeability of Tisilfocon A may help limit hypoxic stress during overnight wear. Overall, these findings suggest that ultra-high Dk Tisilfocon A Ortho-K lenses are well tolerated and clinically effective across diverse patients during this period; however, in the absence of a concurrent control group and given the relatively short follow-up, these results should be regarded as preliminary, and longer-term controlled studies are needed to confirm the durability of axial length control and corneal endothelial safety.

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