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评估新手对日戴型硅水凝胶隐形眼镜的反应:一个为期一个月的随机临床试验研究。

Assessing neophyte response to daily disposable silicone hydrogel contact lenses: A randomised clinical trial investigation over one month.

机构信息

Departamento de Física Aplicada (Área de Optometría), Facultade de Óptica e Optometría, Universidade de Santiago de Compostela, Santiago de Compostela, Spain.

AC-24 Optometría, Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), Santiago de Compostela, Spain.

出版信息

Ophthalmic Physiol Opt. 2024 Jul;44(5):876-883. doi: 10.1111/opo.13328. Epub 2024 May 7.

DOI:10.1111/opo.13328
PMID:38712751
Abstract

OBJECTIVE

This randomised clinical trial assessed the impact on symptoms, tear film dynamics and ocular surface integrity of daily disposable silicone-hydrogel contact lenses (CLs) over a month, paying special attention to lid wiper epitheliopathy (LWE) and its implications for CL discomfort.

METHODS

Neophyte CL wearers (n = 44, 21.09 ± 5.00 years old) were randomly assigned to either the experimental (n = 24) or control group (n = 20). Participants assigned to the experimental group were required to wear daily disposable CLs for 1 month for at least 8 h/day and 6 days/week. All participants were healthy subjects (no history of ocular surgery or active ocular disease) with spherical refractive errors between -8.00 and +5.00 D and cylindrical power <0.75 D. At the baseline and 1-month sessions, the Dry Eye Questionnaire 5 (DEQ-5) was completed, together with the measurement of tear film osmolarity with the TearLab osmometer, tear meniscus height (TMH) and lipid layer pattern (LLP) using a slit-lamp with Tearscope Plus attached, fluorescein break-up time (FBUT), maximum blink interval (MBI), corneal staining with fluorescein under cobalt blue light and LWE with lissamine green under slit lamp and halogen white light.

RESULTS

At the baseline session, LWE showed a negative correlation with DEQ-5 (r = -0.37, p = 0.02). Significant differences in FBUT and LWE (p = 0.04) and a positive correlation between LWE and DEQ-5 (r = 0.49, p = 0.007) were observed at 1 month. Intrasession analysis at 1 month showed significant differences between the experimental and control groups in DEQ-5, FBUT and LWE (all p ≤ 0.02). Intersession analysis in the experimental group showed variations in DEQ-5, FBUT and LWE (all p ≤ 0.02) but no significant variation in the control group (all p ≥ 0.11).

CONCLUSION

The presence of LWE was significantly correlated with higher symptom values in the DEQ-5. Also, participants in the experimental group presented higher values of LWE after 1 month of CL wear, in comparison with the control group.

摘要

目的

本随机临床试验评估了每日更换型硅水凝胶隐形眼镜(CL)在一个月内对症状、泪膜动力学和眼表面完整性的影响,特别关注睑板腺功能障碍(LWE)及其对 CL 不适的影响。

方法

新佩戴隐形眼镜者(n=44,21.09±5.00 岁)被随机分配至实验组(n=24)或对照组(n=20)。实验组要求佩戴每日更换型 CL,每天至少 8 小时,每周 6 天。所有参与者均为健康受试者(无眼部手术史或活动性眼部疾病),球镜屈光度在-8.00 至+5.00 D 之间,柱镜屈光度<0.75 D。在基线和 1 个月时,完成干眼问卷 5 项(DEQ-5),同时使用 TearLab 渗透压仪测量泪膜渗透压,使用带有 Tearscope Plus 的裂隙灯测量泪膜新月高度(TMH)和脂质层模式(LLP),使用荧光素染色评估角膜染色,使用钴蓝光和卤钨白光灯评估丽丝胺绿染色下的 LWE。

结果

在基线时,LWE 与 DEQ-5 呈负相关(r=-0.37,p=0.02)。在 1 个月时,FBUT 和 LWE 存在显著差异(p=0.04),LWE 与 DEQ-5 之间存在正相关(r=0.49,p=0.007)。在 1 个月的组内分析中,实验组在 DEQ-5、FBUT 和 LWE 方面与对照组存在显著差异(均 p≤0.02)。实验组在 1 个月的组间分析中,DEQ-5、FBUT 和 LWE 存在变化(均 p≤0.02),但对照组无显著变化(均 p≥0.11)。

结论

LWE 的存在与 DEQ-5 中更高的症状值显著相关。此外,与对照组相比,实验组在佩戴 CL 一个月后 LWE 值更高。

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Ophthalmic Physiol Opt. 2024 Jul;44(5):876-883. doi: 10.1111/opo.13328. Epub 2024 May 7.
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