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).
CONCLUSIONS: 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.
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).
CONCLUSIONS: 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：这项随机临床试验评估了对症状的影响，每日一次性硅水凝胶隐形眼镜（CLs）在一个月内的泪膜动力学和眼表完整性，特别注意盖子刮水器上皮病变（LWE）及其对CL不适的影响。
方法：将新生CL佩戴者（n=44，21.09±5.00岁）随机分为实验组（n=24）或对照组（n=20）。被分配到实验组的参与者被要求每天佩戴一次性CLs1个月，至少8小时/天和6天/周。所有参与者均为健康受试者（无眼科手术史或活动性眼病史），球面屈光不正在-8.00至+5.00D之间，柱面屈光度<0.75D。干眼问卷5（DEQ-5）完成，用TearLab渗透压计测量泪膜渗透压，泪液半月板高度（TMH）和脂质层模式（LLP）使用裂隙灯，荧光素分解时间（FBUT），最大闪烁间隔(MBI),在钴蓝光下使用荧光素进行角膜染色，在裂隙灯和卤素白光下使用LWE进行Lissamine绿色。
结果：在基线会议上，LWE与DEQ-5呈负相关(r=-0.37,p=0.02)。在1个月时观察到FBUT和LWE的显着差异（p=0.04）以及LWE和DEQ-5之间的正相关（r=0.49，p=0.007）。1个月时的侵入分析显示，实验组和对照组在DEQ-5，FBUT和LWE方面存在显着差异（所有p≤0.02）。实验组的会间期分析显示DEQ-5，FBUT和LWE的变化（所有p≤0.02），但对照组没有显着变化（所有p≥0.11）。
结论：在DEQ-5中，LWE的存在与更高的症状值显著相关。此外，实验组的参与者在CL磨损1个月后表现出更高的LWE值，与对照组相比。
方法：将新生CL佩戴者（n=44，21.09±5.00岁）随机分为实验组（n=24）或对照组（n=20）。被分配到实验组的参与者被要求每天佩戴一次性CLs1个月，至少8小时/天和6天/周。所有参与者均为健康受试者（无眼科手术史或活动性眼病史），球面屈光不正在-8.00至+5.00D之间，柱面屈光度<0.75D。干眼问卷5（DEQ-5）完成，用TearLab渗透压计测量泪膜渗透压，泪液半月板高度（TMH）和脂质层模式（LLP）使用裂隙灯，荧光素分解时间（FBUT），最大闪烁间隔(MBI),在钴蓝光下使用荧光素进行角膜染色，在裂隙灯和卤素白光下使用LWE进行Lissamine绿色。
结果：在基线会议上，LWE与DEQ-5呈负相关(r=-0.37,p=0.02)。在1个月时观察到FBUT和LWE的显着差异（p=0.04）以及LWE和DEQ-5之间的正相关（r=0.49，p=0.007）。1个月时的侵入分析显示，实验组和对照组在DEQ-5，FBUT和LWE方面存在显着差异（所有p≤0.02）。实验组的会间期分析显示DEQ-5，FBUT和LWE的变化（所有p≤0.02），但对照组没有显着变化（所有p≥0.11）。
结论：在DEQ-5中，LWE的存在与更高的症状值显著相关。此外，实验组的参与者在CL磨损1个月后表现出更高的LWE值，与对照组相比。
