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用于连续佩戴的硬性与软性高透氧性隐形眼镜的临床性能比较

Comparative clinical performance of rigid versus soft hyper Dk contact lenses used for continuous wear.

作者信息

Maldonado-Codina Carole, Morgan Philip B, Efron Nathan, Efron Suzanne

机构信息

Eurolens Research, Faculty of Life Sciences, The University of Manchester, Manchester, UK.

出版信息

Optom Vis Sci. 2005 Jun;82(6):536-48. doi: 10.1097/00006324-200506000-00018.

Abstract

PURPOSE

The purpose of this study is to investigate the comparative clinical performance of two hyper Dk contact lenses: a silicone hydrogel lens (Focus Night & Day, Ciba Vision) and a rigid lens (Z-alpha, Menicon Co. Ltd.) when worn for up to 30 days of continuous wear (CW). The rigid lens was worn on an unplanned replacement basis, whereas the soft lens was replaced monthly.

METHODS

One hundred subjects were recruited. Fifty neophyte subjects were randomly assigned into one of the lens types (25 subjects per lens type). Twenty-five existing daily wear (DW) rigid lens users wore the rigid study lens and 25 existing DW soft lens users wore the soft study lens. Visual acuity, lens fit, keratometry, refraction, lens surface assessment, physiological response, and subjective response were investigated at baseline and after 1 week of DW and 24 hours, 1 week, and 1, 3, 6, 9, and 12 months of CW. Analysis compared lens type (rigid vs. soft) and subject group (experienced vs. neophyte).

RESULTS

Sixty-eight subjects completed the study. Visual acuity was similar for the two lens types and subject groups. Lens fit was judged to be adequate in all subjects. Corneal curvature of subjects in the rigid groups became flatter by 0.13 mm compared with 0.04 mm for subjects in the soft lens groups (F = 14.7, p = 0.0003); the refractive findings mirrored these corneal changes. The increasing rate of deposition on rigid lenses was consistent with the fact that these lenses were not replaced during the study. Conjunctival hyperemia and staining were similar for the two lens types but greater among experienced wearers at baseline (F = 13.8, p = 0.0005; F = 5.3, p = 0.02, respectively). Corneal staining was higher for the rigid lens wearers (F = 5.6, p = 0.02) but this was mainly the result of the initial higher scores in the rigid lens experienced group. The change in papillary conjunctivitis was greater for subjects in the soft lens groups than rigid lens groups (F = 4.6, p = 0.04). Comfort was initially lower for the rigid lens neophyte group (F = 4.2, p = 0.0001), but after the CW phase started, there were no differences between groups.

CONCLUSIONS

Notwithstanding subtle differences in physiological responses, continuous wear hyper Dk rigid and soft silicone-containing contact lenses can be successfully worn by both those with previous contact lens experience and those with no history of contact lens wear.

摘要

目的

本研究旨在调查两种高透氧性隐形眼镜的临床性能对比:一种硅水凝胶镜片(日夜型焦点镜片,博士伦公司)和一种硬性镜片(Z-alpha,美尼康株式会社),连续佩戴(CW)长达30天。硬性镜片采用非计划性更换,而软性镜片每月更换。

方法

招募了100名受试者。50名新手受试者被随机分配到其中一种镜片类型中(每种镜片类型25名受试者)。25名现有的日戴(DW)硬性镜片使用者佩戴硬性研究镜片,25名现有的DW软性镜片使用者佩戴软性研究镜片。在基线时、日戴1周后以及连续佩戴24小时、1周、1、3、6、9和12个月后,对视力、镜片适配度、角膜曲率测量、验光、镜片表面评估、生理反应和主观反应进行了调查。分析比较了镜片类型(硬性与软性)和受试者组(有经验的与新手)。

结果

68名受试者完成了研究。两种镜片类型和受试者组的视力相似。所有受试者的镜片适配度均被判定为合适。硬性镜片组受试者的角膜曲率比软性镜片组受试者平坦了0.13毫米,而软性镜片组受试者为0.04毫米(F = 14.7,p = 0.0003);验光结果反映了这些角膜变化。硬性镜片上沉积物的增加速率与研究期间这些镜片未更换的事实一致。两种镜片类型的结膜充血和染色情况相似,但在基线时,有经验的佩戴者中更为严重(分别为F = 13.8,p = 0.0005;F = 5.3,p = 0.02)。硬性镜片佩戴者的角膜染色更高(F = 5.6,p = 0.02),但这主要是硬性镜片有经验组初始得分较高的结果。软性镜片组受试者的乳头性结膜炎变化比硬性镜片组更大(F = 4.6,p = 0.04)。硬性镜片新手组的舒适度最初较低(F = 4.2,p = 0.0001),但在连续佩戴阶段开始后,各组之间没有差异。

结论

尽管生理反应存在细微差异,但有隐形眼镜佩戴经验者和无隐形眼镜佩戴史者都能成功佩戴连续佩戴的高透氧性硬性和含硅软性隐形眼镜。

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