Clinical performance of a custom-designed soft contact lens in patients with keratoconus and intolerance to rigid contact lenses

Purpose This study evaluated the efficacy and safety of YOUSOFT ® soft contact lens (CL) (TOMEY-CL) in patients with keratoconus and intolerance to rigid CLs. Study design Retrospective observational study. Methods Thirty-six eyes of 20 patients (14 men and 6 women) with keratoconus and rigid CL intolerance were included in the study. Four patients were unilateral. The mean age was 33.1 ± 11.7 (± standard deviation) years, the mean spherical refractive error was − 4.99 ± 3.97 D, and the mean cylindrical refractive error was − 3.39 ± 2.13 D. The following examinations were performed at baseline and were repeated at every visit; refractometry, visual acuity, corneal topography and pachymetry with an anterior OCT system. Corneal endothelial cell density was evaluated at baseline and every 6 months. Slit-lamp examination was also performed to confirm the CL condition and ocular health at every visit. Results Seventeen patients (85%) were able to continue using the Yousoft. Among 3 patients (15%) who dropped out, 2 were dissatisfied with their visual outcomes and one had trouble with lens handling. Uncorrected visual acuity was 1.08 ± 0.43 (range: 0.22 to 2.00) logMAR at baseline, and best CL-corrected visual acuity was 0.01 ± 0.15 (range: − 0.18 to 0.40) logMAR, showing a significant improvement after wearing Yousoft (P < 0.0001). The endothelial cell density did not change significantly, with 2373 ± 482 at baseline and 2402 ± 464 cells/mm 2 at the latest visit after lens prescription (P = 0.351). There were no severe complications such as corneal infiltrates or infectious keratitis throughout the study period. Conclusions This study showed the efficacy and acceptable safety of Yousoft for patients with keratoconus and intolerance to rigid CLs.