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“舒适增强型”日抛软性隐形眼镜的临床实际效果。

Objective clinical performance of 'comfort-enhanced' daily disposable soft contact lenses.

机构信息

Aston University, Aston Triangle, Birmingham, United Kingdom.

出版信息

Cont Lens Anterior Eye. 2010 Apr;33(2):88-92. doi: 10.1016/j.clae.2010.01.004. Epub 2010 Feb 9.

Abstract

PURPOSE

To examine the objective clinical performance of 'comfort-enhanced' daily disposable contact lenses over a 16-h day.

METHODS

Four contact lenses (Hilafilcon B, Etafilcon A Plus, Nelfilcon A and Nelfilcon A Plus) were evaluated in an investigator masked, open label trial at the end of a week's bilateral wear. Pre-lens non-invasive tear break-up time (PL-NITBUT), tear prism height, bulbar hyperaemia and ocular surface temperature (OST) were measured with the lens in situ at 8, 12 and 16h of wear.

RESULTS

There was no difference between how many hours the lenses types were worn each day (F=0.90, p=0.44). The PL-NITBUT decreased with the duration of daily lens wear (F=32.0, p<0.001) and was more stable with Nelfilcon A Plus (F=6.00, p=0.002) than with the other lenses evaluated. Bulbar blood vessels increased in coverage (F=11.5, p<0.001) but not overall redness (F=0.0, p=0.99) with the duration of daily lens wear, but there was no difference between the lenses (p>0.05). The tear prism height decreased with the duration of daily wear (F=27.0, p<0.001) and differed between lenses (F=2.9, p=0.04). The OST decreased with the duration of lens wear (F=119.7, p<0.001) and was reduced by daily disposable lens wear (F=7.88, p<0.001), but did not differ between lenses (F=0.88, p=0.45).

CONCLUSIONS

Objective measures of tear film indicated a difference between the lenses evaluated for PL-NITBUT and tear prism height, but not for wearing time or bulbar conjunctival hyperaemia. Therefore clinical benefits of daily disposable 'comfort enhancing' contact lenses can be measured, but challenges remain in producing contact lenses that do not compromise anterior eye physiology over the whole day.

摘要

目的

研究“舒适增强”日抛型隐形眼镜在 16 小时佩戴周期内的客观临床性能。

方法

在一周的双侧佩戴结束时,采用研究者盲法、开放标签试验对 4 种隐形眼镜(Hilafilcon B、Etafilcon A Plus、Nelfilcon A 和 Nelfilcon A Plus)进行评估。在佩戴隐形眼镜的情况下,于 8、12 和 16 小时测量镜片前非侵入性泪膜破裂时间(PL-NITBUT)、泪液棱镜高度、球结膜充血和眼表面温度(OST)。

结果

各隐形眼镜类型每天佩戴的时间没有差异(F=0.90,p=0.44)。PL-NITBUT 随每日佩戴时间的延长而降低(F=32.0,p<0.001),Nelfilcon A Plus 比其他评估的镜片更为稳定(F=6.00,p=0.002)。随着每日佩戴时间的延长,球结膜血管覆盖面积增加(F=11.5,p<0.001),但总体充血无变化(F=0.0,p=0.99),但镜片之间无差异(p>0.05)。泪液棱镜高度随每日佩戴时间的延长而降低(F=27.0,p<0.001),且镜片之间存在差异(F=2.9,p=0.04)。OST 随镜片佩戴时间的延长而降低(F=119.7,p<0.001),且日抛型隐形眼镜佩戴会降低 OST(F=7.88,p<0.001),但镜片之间无差异(F=0.88,p=0.45)。

结论

泪膜的客观测量指标表明,评估的镜片在 PL-NITBUT 和泪液棱镜高度方面存在差异,但在佩戴时间或球结膜充血方面无差异。因此,可对每日 disposable“舒适增强”隐形眼镜的临床益处进行评估,但在全天不影响眼前节生理的情况下,仍然存在制造隐形眼镜的挑战。

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