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硅水凝胶材料用于日常佩戴。

Use of silicone hydrogel material for daily wear.

作者信息

Guillon Michel, Maissa Cécile

机构信息

Optometric Technology Group Research and Consultancy, 66 Buckingham Gate, London SW1E 6AU, UK.

出版信息

Cont Lens Anterior Eye. 2007 Mar;30(1):5-10; quiz 71. doi: 10.1016/j.clae.2006.09.008. Epub 2006 Nov 13.

Abstract

Silicone hydrogel contact lenses were initially developed to optimise oxygen transmissibility for extended wear use. The concerns with such contact lenses have been their higher elastomeric and hydrophobic characteristics associated with the incorporation of silicone type monomers. The use of silicone hydrogel has most recently been suggested for daily wear to eliminate all hypoxic related problems. The primary aim of the investigation was to test in vivo wetting performance and subjective acceptance of the first silicone hydrogel contact lens developed for daily wear, ACUVUE ADVANCE with HYDRACLEAR (galyfilcon A), compared to a conventional hydrogel contact lens for the same application SofLens 66 (alphafilcon A). The investigation was a randomised, subject masked bilateral cross over investigation testing of the two contact lens materials over their approved replacement periods (galyfilcon A 2 weeks and alphafilcon A 2 weeks (USA) and 4 weeks (Europe)). In all cases ReNu Multiplus lens care system was used. The investigation carried out on 24 contact lens wearers showed that: (i) in vivo wettability was superior for galyfilcon A which had a thicker lipid layer (thin layer incidence: galyfilcon A 54%; alphafilcon A 70-86%, p<0.05), a thicker aqueous layer (thick layer incidence: galyfilcon A 88%; alphafilcon A 35-64%, p<0.05) and a more stable tear film (galyfilcon A 7.8s; alphafilcon A 2 weeks 5.6s, p=0.022; 4 weeks 7.4s, p=0.276); (ii) for the intended replacement period, comfort was better with galyfilcon A (2 weeks) compared to alphafilcon A (4 weeks) at insertion (p=0.001) and, throughout the day (daytime and evening p=0.008). Contact lenses made from galyfilcon A and replaced two weekly achieved better in vivo wettability than contact lenses made from alphafilcon A and replaced either two and four weekly; the better wettability was associated with an overall better comfort for galyfilcon A.

摘要

硅水凝胶隐形眼镜最初是为优化长戴型的透氧性而研发的。这类隐形眼镜存在的问题在于,由于加入了硅氧烷类单体,其具有较高的弹性和疏水性。最近有人建议将硅水凝胶用于日戴型,以消除所有与缺氧相关的问题。本研究的主要目的是,在体内测试首款为日戴型研发的硅水凝胶隐形眼镜ACUVUE ADVANCE with HYDRACLEAR(加丽菲康A)的湿润性能和主观接受度,并与用于相同用途的传统水凝胶隐形眼镜SofLens 66(阿法菲康A)进行比较。该研究是一项随机、受试者遮蔽的双侧交叉研究,在两种隐形眼镜材料的批准更换周期内(加丽菲康A为2周,阿法菲康A在美国为2周,在欧洲为4周)对其进行测试。在所有情况下均使用润明多功能护理系统。对24名隐形眼镜佩戴者进行的研究表明:(i)加丽菲康A在体内的润湿性更佳,其脂质层更厚(薄脂质层发生率:加丽菲康A为54%;阿法菲康A为70 - 86%,p<0.05),水层更厚(厚水层发生率:加丽菲康A为88%;阿法菲康A为35 - 64%,p<0.05),泪膜更稳定(加丽菲康A为7.8秒;阿法菲康A在2周时为5.6秒,p = 0.022;在4周时为7.4秒,p = 0.276);(ii)在预期的更换周期内,加丽菲康A(2周)在佩戴时(p = 0.001)以及一整天(白天和晚上,p = 0.008)的舒适度均优于阿法菲康A(4周)。由加丽菲康A制成且每两周更换一次的隐形眼镜在体内的润湿性优于由阿法菲康A制成且每两周或四周更换一次的隐形眼镜;加丽菲康A更好的润湿性与总体更佳的舒适度相关。

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