Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan.
Jpn J Ophthalmol. 2022 Jul;66(4):350-357. doi: 10.1007/s10384-022-00924-1. Epub 2022 Jun 7.
This study evaluated the efficacy and safety of YOUSOFT soft contact lens (CL) (TOMEY-CL) in patients with keratoconus and intolerance to rigid CLs.
Retrospective observational study.
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.
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 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.
This study showed the efficacy and acceptable safety of Yousoft for patients with keratoconus and intolerance to rigid CLs.
本研究评估了 YOUSOFT 软性隐形眼镜（CL）（TOMEY-CL）在圆锥角膜和不能耐受硬性 CL 患者中的疗效和安全性。
回顾性观察研究。
本研究纳入了 20 名患者（14 名男性和 6 名女性）的 36 只眼，这些患者均患有圆锥角膜且不能耐受硬性 CL。其中 4 名患者为单侧患病。平均年龄为 33.1 ± 11.7（±标准差）岁，平均球镜屈光度为-4.99 ± 3.97 D，平均柱镜屈光度为-3.39 ± 2.13 D。在基线时和每次就诊时进行以下检查：屈光检查、视力、角膜地形图和前节 OCT 系统角膜厚度测量。在基线和每 6 个月时评估角膜内皮细胞密度。每次就诊时还进行裂隙灯检查以确认 CL 状况和眼部健康。
17 名患者（85%）能够继续使用 Yousoft。在 3 名（15%）退出的患者中，2 名对视力结果不满意，1 名对镜片处理有困难。未矫正视力在基线时为 1.08 ± 0.43（范围：0.22 至 2.00）logMAR，最佳 CL 矫正视力为 0.01 ± 0.15（范围：-0.18 至 0.40）logMAR，佩戴 Yousoft 后视力显著提高（P < 0.0001）。内皮细胞密度无显著变化，在基线时为 2373 ± 482 个细胞/mm，在镜片处方后最近一次就诊时为 2402 ± 464 个细胞/mm（P = 0.351）。在整个研究期间，没有发生严重并发症，如角膜浸润或感染性角膜炎。
本研究表明，Yousoft 对圆锥角膜和不能耐受硬性 CL 的患者有效且安全性可接受。
