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.
(© 2022. Japanese Ophthalmological Society.)