The Madurai Intraocular Lens Study - I: A randomized clinical trial comparing complications and vision outcomes of intracapsular cataract extraction and extracapsular cataract extraction with posterior chamber intraocular lens

被引:24
作者
Natchiar, GN
Thulasiraj, RD
Negrel, AD
Bangdiwala, S
Rahmathallah, R
Prajna, NV
Ellwein, LB
Kupfer, C
机构
[1] NEI, Bethesda, MD 20892 USA
[2] Aravind Eye Hosp & Postgrad Inst Ophthalmol, Madurai, Tamil Nadu, India
[3] WHO, Prevent Blindness Program, CH-1211 Geneva, Switzerland
[4] Univ N Carolina, Chapel Hill, NC USA
[5] Postgrad Inst Ophthalmol, Madurai, Tamil Nadu, India
基金
美国国家卫生研究院;
关键词
D O I
10.1016/S0002-9394(99)80229-3
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
PURPOSE: The Madurai Intraocular Lens Study (MIOLS) was designed to compare safety, efficacy, and quality of life outcomes after either intracapsular cataract extraction with aphakic glasses (ICCE-AG) or extracapsular cataract extraction with posterior chamber intraocular lens (ECCE/PC-IOL). METHODS: The Madurai Intraocular Lens Study was a nonmasked randomized controlled clinical trial conducted at a single hospital. Thirty four hundred patients with age-related cataracts and having a best corrected visual acuity less than or equal to 20/120 in the better eye were randomly assigned to either of the two cataract operative procedures. The main clinical outcomes were safety (complication rates) and efficacy (best-corrected visual acuity at 1 year equal to or better than 20/40). In addition, a subset of 1,700 trial participants received questionnaires before surgery, at 6 months after surgery, and at 1 year after surgery to measure visual functioning and vision related quality of life. RESULTS: Details of study design, study organization, clinical and quality of life outcome variables, sample size calculations, patient eligibility criteria and recruitment, randomization and masking, participant flow, adherence to follow-up, quality assurance, and statistical methods are presented. CONCLUSIONS: The Madurai Intraocular Lens Study has sufficient power to detect clinically significant differences between the treatment options. There were no statistically significant differences between the two treatment groups for any of the major study variables at baseline. A high level of quality assurance was maintained throughout the October 1993 to June 1996 study period. The results should be applicable to all settings where the requisite expertise and resources are present.
引用
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页码:1 / 13
页数:13
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