对有症状的隐形眼镜佩戴者每日更换一次性隐形眼镜的随机试验。

IF 2.9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Journal of Clinical Medicine Pub Date : 2025-09-18 DOI:10.3390/jcm14186575

José Miguel Sánchez-Ruiz, A Eusebio López-Hernández, Youssef Abidi, Johnny Di Pierdomenico, Diego García-Ayuso

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引用次数: 0

摘要

背景/目的：隐形眼镜不适（CLD）是一个普遍的问题，影响了多达50%的佩戴者，并导致约30%的病例停止使用。本研究旨在评估将有症状的每月更换隐形眼镜（CL）佩戴者更换为新的每日一次性隐形眼镜（Kalifilcon a DDCL）的影响，并将其与安慰剂CL的效果进行比较。方法：招募79名有症状的患者（CLDEQ-8≥12，平均年龄27.07±8.38岁，77%为女性），随机分配使用Kalifilcon A ddcl或安慰剂CLs。参与者在基线和佩戴一个月后进行评估。主观测量包括CLDEQ-8和NEI VFQ-25问卷。客观评价包括泪膜稳定性和眼表健康。统计学分析采用配对t检验和重复测量方差分析。多重比较采用Bonferroni校正，结果用效应量（Cohen’s d）和95%置信区间报告。p < 0.05为差异有统计学意义。结果：Kalifilcon A DDCL患者CLDEQ-8评分显著降低（18.5±4.6 ~ 10.8±8.5;p < 0.005; Cramer’s V: 0.594; 95% CI: 13.35 ~ 15.34），仅33%患者仍有症状。视力相关生活质量改善（75.83±8.0 ~ 83.5±8.6;p < 0.005; Cramer’s V: 0.977; 95% CI: 78.54 ~ 80.81），特别是在眼痛（p < 0.001; Cramer’s V: 0.755; 95% CI: 54.73 ~ 58.88）、角色困难（p < 0.001; Cramer’s V: 0.812; 95% CI: 35.12 ~ 42.77）和色觉（p < 0.05; Cramer’s V: 0.575; 95% CI: 93.07 ~ 95.63）方面。与安慰剂CL相比，Kalifilcon A ddcl在舒适度（p < 0.0001; Cramer's V: 0.329; 95% CI: 7.22-7.74）、视力（p < 0.0001; Cramer's V: 0.267; 95% CI: 7.38-7.85）和满意度（p = 0.005; Cramer's V: 0.208; 95% CI: 7.70-8.18）方面有更大的改善。泪膜稳定性也显著改善（p < 0.05），安慰剂组无变化。结论：使用Kalifilcon A ddcl对有症状的CL佩戴者进行改装，可显著改善舒适性，减轻CLD症状，提高视力相关的生活质量。这些结果支持在有症状的个体中使用它作为每月cl的有益替代。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

A Randomized Trial on the Benefits of Refitting Symptomatic Contact Lens Wearers with Daily Disposable Lenses.

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A Randomized Trial on the Benefits of Refitting Symptomatic Contact Lens Wearers with Daily Disposable Lenses.

Background/Objective: Contact lens discomfort (CLD) is a prevalent issue affecting up to 50% of wearers and contributes to discontinuation in approximately 30% of cases. This study aimed to evaluate the impact of refitting symptomatic monthly replacement contact lens (CL) wearers with a new daily, disposable contact lens (Kalifilcon A DDCL) and to compare its effectiveness against a placebo CL. Methods: Seventy-nine symptomatic wearers (CLDEQ-8 ≥ 12; mean age 27.07 ± 8.38 years; 77% female) were recruited and randomly assigned to wear either Kalifilcon A DDCLs or placebo CLs. Participants were assessed at baseline and after one month of CL wear. Subjective measures included the CLDEQ-8 and the NEI VFQ-25 questionnaire. Objective assessments included tear film stability and ocular surface health. Statistical analysis was performed using paired t-tests and repeated-measures ANOVA. Bonferroni correction was applied for multiple comparisons, and results were reported with effect sizes (Cohen's d) and 95% confidence intervals. Statistical significance was set at p < 0.05. Results: Kalifilcon A DDCL wearers showed a significant reduction in CLDEQ-8 scores (18.5 ± 4.6 to 10.8 ± 8.5; p < 0.005; Cramer's V: 0.594; 95% CI: 13.35-15.34), with only 33% remaining symptomatic. Vision-related quality of life improved (75.83 ± 8.0 to 83.5 ± 8.6; p < 0.005; Cramer's V: 0.977; 95% CI: 78.54-80.81), especially in ocular pain (p < 0.001; Cramer's V: 0.755; 95% CI: 54.73-58.88), role difficulties (p < 0.001; Cramer's V: 0.812; 95% CI: 35.12-42.77), and color vision (p < 0.05; Cramer's V: 0.575; 95% CI: 93.07-95.63). Compared to the placebo CL, Kalifilcon A DDCLs led to greater improvements in comfort (p < 0.0001; Cramer's V: 0.329; 95% CI: 7.22-7.74), visual acuity (p < 0.0001; Cramer's V: 0.267; 95% CI: 7.38-7.85), and satisfaction (p = 0.005; Cramer's V: 0.208; 95% CI: 7.70-8.18). Tear film stability also improved significantly (p < 0.05), with no changes observed in the placebo group. Conclusions: Refitting symptomatic CL wearers with Kalifilcon A DDCLs significantly improves comfort, reduces CLD symptoms, and enhances vision-related quality of life. These results support its use as a beneficial alternative to monthly CLs in symptomatic individuals.

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来源期刊

Journal of Clinical Medicine MEDICINE, GENERAL & INTERNAL-

CiteScore

5.70

自引率

7.70%

发文量

6468

审稿时长

16.32 days

期刊介绍： Journal of Clinical Medicine (ISSN 2077-0383), is an international scientific open access journal, providing a platform for advances in health care/clinical practices, the study of direct observation of patients and general medical research. This multi-disciplinary journal is aimed at a wide audience of medical researchers and healthcare professionals. Unique features of this journal: manuscripts regarding original research and ideas will be particularly welcomed.JCM also accepts reviews, communications, and short notes. There is no limit to publication length: our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible.