Carnt Nicole A, Evans Victoria E, Naduvilath Thomas J, Willcox Mark D P, Papas Eric B, Frick Kevin D, Holden Brien A
BOptom, Institute for Eye Research, Level 3, Rupert Myers Building, University of New South Wales, Sydney, NSW 2052, Australia.
Arch Ophthalmol. 2009 Dec;127(12):1616-23. doi: 10.1001/archophthalmol.2009.313.
To investigate the incidence of adverse events related to the use of varying silicone hydrogel contact lens and lens solution combinations.
Individuals with myopia (N = 558) participated in 1 or more of approximately 40-participant trials in a matrix of 20 silicone hydrogel contact lens and lens-solution combinations. Visits were at baseline, 2 weeks, 1 month, and 3 months. The mean study completion rate was 90% of the expected participant-months (final data set: 840 lens-solution combinations and 2271 participant-months). Adverse events were reported as the first occurrence of each type per 100 participant-months for each lens-solution combination.
The rate of all corneal infiltrative events (CIEs) was 3.1 per 100 participant-months (range, 0-10.5), and the rate of symptomatic CIEs was 1.7 per 100 participant-months (range, 0-10.5), including 1 case of microbial keratitis (0.04 per 100 participant-months). Rates for CIEs differed substantially among solution groups, with hydrogen peroxide having the lowest rate (0.6 per 100 participant-months; range, 0-0.9). The rate was 0.8 per 100 participant-months (range, 0-8.0) for superior epithelial arcuate lesions, which varied by lens type, 0.04 per 100 participant-months (1 case only) for corneal erosion, and 0.4 per 100 participant-months (range, 0-2.0) for contact lens papillary conjunctivitis, which was modified by type of solution. The rate of solution-induced corneal staining for all lens-solution combinations was 4.7 per 100 participant-months (range, 0-23) and varied significantly based on lens-solution combination (P < .001).
The frequency of adverse events varied with silicone hydrogel contact lens and lens solution combinations, with hydrogen peroxide having the lowest incidence of CIEs and solution-induced corneal staining, indicating that lens material and design, type of solution, and solution-lens interactions are likely contributing factors in this mode of lens wear.
研究使用不同硅水凝胶隐形眼镜与护理液组合相关不良事件的发生率。
近视患者（N = 558）参与了约40项试验中的1项或多项，试验采用20种硅水凝胶隐形眼镜与护理液组合的矩阵形式。访视点为基线、2周、1个月和3个月。平均研究完成率为预期参与者月数的90%（最终数据集：840种护理液组合和2271参与者月数）。不良事件报告为每种护理液组合每100参与者月每种类型的首次发生情况。
所有角膜浸润性事件（CIE）的发生率为每100参与者月3.1例（范围0 - 10.5），有症状的CIE发生率为每100参与者月1.7例（范围0 - 10.5），包括1例微生物性角膜炎（每100参与者月0.04例）。CIE发生率在护理液组间差异很大，过氧化氢组发生率最低（每100参与者月0.6例；范围0 - 0.9）。上皮性弓形病变发生率为每100参与者月0.8例（范围0 - 8.0），因镜片类型而异；角膜糜烂发生率为每100参与者月0.04例（仅1例）；接触镜乳头状结膜炎发生率为每100参与者月0.4例（范围0 - 2.0），因护理液类型而异。所有护理液组合的护理液引起的角膜染色发生率为每100参与者月4.例（范围0 - 23），且因护理液组合不同差异显著（P < .001）。
不良事件的发生频率因硅水凝胶隐形眼镜与护理液组合而异，过氧化氢引起的CIE和护理液引起的角膜染色发生率最低，表明镜片材料和设计、护理液类型以及护理液与镜片的相互作用可能是这种佩戴方式下的影响因素。
