Eye Hospital, Wenzhou Medical University, National Clinical Research Center for Ocular Diseases, Wenzhou, Zhejiang 325027, China.
Vision X Medical Technology Co., Ltd., Shanghai 201114, China.
Cont Lens Anterior Eye. 2024 Apr;47(2):102108. doi: 10.1016/j.clae.2023.102108. Epub 2024 Jan 3.
To investigate the settling characteristics of a scleral lens in Chinese adults with refractive error and to provide guidance for its clinical application.
A total of 21 healthy Chinese adults (27.2 ± 4.1 years) with refractive error were enrolled in this study. The average spherical equivalent was -5.50 ± 2.92 D. Subjects were fitted with 15.6 mm diameter scleral lenses. The central post-lens tear thickness (PoLTT) was measured immediately after lens placement, 30, 60, 120, and 240 min after lens insertion at the dispensing visit and immediately after lens placement and 240 min after three months through optical coherence tomography. Statistical analyses were conducted using repeated measures analysis of variance and paired-t test.
At the dispensing visit, the amount of settling after 240 min of lens wear was 126 ± 33 μm. After three months, the amount of settling was 98 ± 55 μm after 240 min. No significant difference was detected in the PoLTT immediately after lens placement between the dispensing visit and after three months (t = -0.246, p = 0.807), while a significant difference was noted at 240 min after lens insertion (t = -6.575, p < 0.001). The amount of settling was higher at the dispensing visit than that after three months (average difference = 28 ± 63 μm, t = 2.733, p = 0.01). The prediction model of PoLTT over time was y = 26.263-0.690 × t + 0.001 × t + 0.926 × y (R = 0.939), where y denotes the predicted PoLTT at t min after lens insertion, y denotes the PoLTT at 30 min after lens insertion.
For the investigated small-diameter scleral lens (material: Boston XO, diameter: 15.6 mm, four-zone and periphery toric design), the PoLTT decreased over time after lens insertion in Chinese adults with refractive error, and the amount of settling varied among individuals (range: 71-204 μm). The amount of settling did not increase further after three months, indicating the long-term fitting stability of the scleral lens. Practitioners could estimate the PoLTT using the prediction model based on the PoLTT at 30 min after wearing lenses.
研究中国成年人屈光不正患者巩膜镜的沉降特征，为其临床应用提供指导。
本研究纳入 21 名年龄在 27.2±4.1 岁之间的有屈光不正的健康中国成年人。平均等效球镜度为-5.50±2.92 D。为每位受试者配备直径为 15.6mm 的巩膜镜。在配镜就诊时以及在插入镜片后 30、60、120 和 240 分钟，通过光学相干断层扫描测量中央后泪膜厚度（PoLTT）。使用重复测量方差分析和配对 t 检验进行统计分析。
在配镜就诊时，佩戴 240 分钟后，镜片的沉降量为 126±33μm。三个月后，佩戴 240 分钟后，沉降量为 98±55μm。在配镜就诊时和三个月后，插入镜片后即刻的 PoLTT 无显著差异（t=-0.246，p=0.807），但在插入镜片后 240 分钟时差异显著（t=-6.575，p<0.001）。配镜就诊时的沉降量高于三个月后（平均差值为 28±63μm，t=2.733，p=0.01）。PoLTT 随时间的预测模型为 y=26.263-0.690×t+0.001×t+0.926×y（R=0.939），其中 y 表示插入镜片后 t 分钟的预测 PoLTT，y 表示插入镜片后 30 分钟的 PoLTT。
对于研究中所使用的小直径巩膜镜（材料：Boston XO，直径：15.6mm，四分区和周边散光设计），在中国成年人屈光不正患者中，插入镜片后 PoLTT 随时间逐渐降低，个体间沉降量存在差异（范围：71-204μm）。三个月后，沉降量没有进一步增加，表明巩膜镜具有长期稳定的适配性。临床医生可以根据佩戴镜片后 30 分钟的 PoLTT 使用预测模型来估计 PoLTT。
