Frederick R. Edmunds (OD, FAAO), Timothy L. Comstock MS (OD, FAAO), William T. Reindel MS (OD)
{"title":"PureVision™硅酮水凝胶隐形眼镜的累积临床结果和预计的细菌性角膜炎发生率","authors":"Frederick R. Edmunds (OD, FAAO), Timothy L. Comstock MS (OD, FAAO), William T. Reindel MS (OD)","doi":"10.1016/S0892-8967(02)00082-2","DOIUrl":null,"url":null,"abstract":"<div><p>Concern for microbial keratitis (MK) has been a limiting factor regarding practitioner acceptance of the safety of continuous wear. Nearly 5,800 subjects participated in 27 extended-wear clinical trials of PureVision™ silicone hydrogel lenses coordinated by the Clinical Research Group at Bausch & Lomb. There were no reports of MK in over 2,200 patient-years of experience accumulated in these studies. In an attempt to gain insight into the safety of silicone hydrogel lenses, information from market experience and postmarket product performance data was utilized to extrapolate a prospective incident rate of MK with these lenses. With >2 years of experience in the market it appears that the incident rate of MK for PureVision™ lenses, utilized in all modalities, is tracking lower than that of conventional hydrogel lenses.</p></div>","PeriodicalId":80286,"journal":{"name":"International contact lens clinic (New York, N.Y.)","volume":"27 5","pages":"Pages 182-187"},"PeriodicalIF":0.0000,"publicationDate":"2000-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S0892-8967(02)00082-2","citationCount":"3","resultStr":"{\"title\":\"Cumulative clinical results and projected incident rates of microbial keratitis with PureVision™ silicone hydrogel lenses\",\"authors\":\"Frederick R. Edmunds (OD, FAAO), Timothy L. Comstock MS (OD, FAAO), William T. Reindel MS (OD)\",\"doi\":\"10.1016/S0892-8967(02)00082-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Concern for microbial keratitis (MK) has been a limiting factor regarding practitioner acceptance of the safety of continuous wear. Nearly 5,800 subjects participated in 27 extended-wear clinical trials of PureVision™ silicone hydrogel lenses coordinated by the Clinical Research Group at Bausch & Lomb. There were no reports of MK in over 2,200 patient-years of experience accumulated in these studies. In an attempt to gain insight into the safety of silicone hydrogel lenses, information from market experience and postmarket product performance data was utilized to extrapolate a prospective incident rate of MK with these lenses. With >2 years of experience in the market it appears that the incident rate of MK for PureVision™ lenses, utilized in all modalities, is tracking lower than that of conventional hydrogel lenses.</p></div>\",\"PeriodicalId\":80286,\"journal\":{\"name\":\"International contact lens clinic (New York, N.Y.)\",\"volume\":\"27 5\",\"pages\":\"Pages 182-187\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2000-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/S0892-8967(02)00082-2\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International contact lens clinic (New York, N.Y.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0892896702000822\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International contact lens clinic (New York, N.Y.)","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0892896702000822","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Cumulative clinical results and projected incident rates of microbial keratitis with PureVision™ silicone hydrogel lenses
Concern for microbial keratitis (MK) has been a limiting factor regarding practitioner acceptance of the safety of continuous wear. Nearly 5,800 subjects participated in 27 extended-wear clinical trials of PureVision™ silicone hydrogel lenses coordinated by the Clinical Research Group at Bausch & Lomb. There were no reports of MK in over 2,200 patient-years of experience accumulated in these studies. In an attempt to gain insight into the safety of silicone hydrogel lenses, information from market experience and postmarket product performance data was utilized to extrapolate a prospective incident rate of MK with these lenses. With >2 years of experience in the market it appears that the incident rate of MK for PureVision™ lenses, utilized in all modalities, is tracking lower than that of conventional hydrogel lenses.
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