MacRae S, Herman C, Stulting R D, Lippman R, Whipple D, Cohen E, Egan D, Wilkinson C P, Scott C, Smith R
Food and Drug Administration, Washington, D.C.
Am J Ophthalmol. 1991 Apr 15;111(4):457-65. doi: 10.1016/s0002-9394(14)72381-5.
We analyzed clinical data on 22,739 contact lens wearers who were studied and whose lenses were approved under 48 manufacturer-sponsored studies for the Food and Drug Administration between 1980 and 1988. The incidence of corneal ulcers was low in the cosmetic (nontherapeutic) daily-wear soft and rigid gas-permeable lens wearers (1/1,923 and 1/1,471 patient-years, respectively). Corneal ulcers and severe adverse reactions occurred two to four times more frequently in extended-wear cosmetic soft and rigid gas-permeable lens wearers than in cosmetic daily-wear lens wearers. Aphakic extended-wear soft lens users were nine times more likely to develop a corneal ulcer when compared to the soft daily-wear cosmetic group. Corneal abrasions and keratitis accounted for 81 of 159 severe adverse reactions, whereas corneal ulcers accounted for 28 of 159 adverse reactions. The data indicate that overnight extended wear of contact lenses is associated with a greater risk of serious, sight-threatening complications than daily wear.
我们分析了22739名隐形眼镜佩戴者的临床数据，这些人参与了研究，其使用的隐形眼镜在1980年至1988年间经48项由制造商赞助的研究获得美国食品药品监督管理局批准。在使用软性和硬性透气性美容（非治疗性）日戴型隐形眼镜的人群中，角膜溃疡的发生率较低（分别为每1923和1471患者年1例）。与日戴型美容隐形眼镜佩戴者相比，长戴型美容软性和硬性透气性隐形眼镜佩戴者发生角膜溃疡和严重不良反应的频率高出两到四倍。与软性日戴型美容隐形眼镜组相比，无晶状体长戴型软性隐形眼镜使用者发生角膜溃疡的可能性高出九倍。角膜擦伤和角膜炎占159例严重不良反应中的81例，而角膜溃疡占159例不良反应中的28例。数据表明，与日戴相比，隐形眼镜过夜长戴会带来更高的严重视力威胁性并发症风险。
