Chris Lievens, Amy Perkins, Elyse Rayborn, Yueren Wang, Quentin Franklin, Kristopher May, Shane Kannarr, Morgan Bromley, Andrew D Pucker
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引用次数: 0
Abstract
Purpose: The purpose of this work was to determine the comfort performance of a toric, monthly, silicon hydrogel CL (lehfilcon A; TOTAL30 for Astigmatism) over a long day of wear.
Methods: This was a 1-month, 3-visit, prospective, single-arm study. Adult, 18- to 45-year-old CL wearers with good vision who were minimally symptomatic (CLDEQ-8 scores ≤12) were enrolled. Subjects were required to have astigmatism ranging from -0.75 D to -2.50 D in each eye and were required to wear the study CLs from about 8:00 AM until 12:00 AM each day. Comfort data with the study CL throughout the wear day were collected via text messaging.
Results: A total of 47 subjects who had a mean ± SD age of 29.5 ± 7.0 years were analyzed. Within a specified time point across the month of wear, CL comfort did not vary (all p-value ≥ 0.82), yet CL comfort did decrease across the wear day for all days evaluated (all p-value <0.001). Most subjects found their CLs to be comfortable with only 1.8% of subjects reporting an uncomfortable score at CL application and only 8.5% of subjects reporting an uncomfortable score after 16 hours of CL wear.
Conclusion: A high level of consistency and predictability in comfort was found within the first month of wearing lehfilcon A CLs. This suggests that patients with minimal CL-related discomfort at initial fitting of a lehfilcon A CL may likely tolerate longer wear time with minimal discomfort across the entire month of wear.
目的：本研究的目的是确定环形、月度、硅水凝胶CL (lehfilcon a；TOTAL30散光)在长一天的磨损。方法：这是一项为期1个月，3次就诊的前瞻性单臂研究。受试者为成人，18- 45岁，视力良好，症状轻微（CLDEQ-8评分≤12）。受试者被要求每只眼睛的散光在-0.75 D到-2.50 D之间，并被要求每天早上8:00到12:00左右佩戴研究CLs。研究人员通过短信收集了穿着当天的舒适度数据。结果：共分析了47例患者，平均±SD年龄为29.5±7.0岁。在一个指定的时间点内，整个佩戴月份的CL舒适度没有变化（所有p值均≥0.82），但在所有评估的天数中，CL舒适度确实在佩戴当天有所下降(所有p值结论：在佩戴lehfilcon a CL的第一个月内，舒适度具有高度的一致性和可预测性。这表明，患者在最初试装lehfilcon a CL时最小的CL相关不适可能会忍受更长的佩戴时间，并且在整个佩戴期间最小的不适。临床试验编号：NCT06052046。
期刊介绍：
Clinical Optometry is an international, peer-reviewed, open access journal focusing on clinical optometry. All aspects of patient care are addressed within the journal as well as the practice of optometry including economic and business analyses. Basic and clinical research papers are published that cover all aspects of optics, refraction and its application to the theory and practice of optometry. Specific topics covered in the journal include: Theoretical and applied optics, Delivery of patient care in optometry practice, Refraction and correction of errors, Screening and preventative aspects of eye disease, Extended clinical roles for optometrists including shared care and provision of medications, Teaching and training optometrists, International aspects of optometry, Business practice, Patient adherence, quality of life, satisfaction, Health economic evaluations.
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