Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric

Alcon Research2 个研究点分布在 1 个国家开始时间: 2008年9月29日最近更新: 2015年5月12日

适应症

试验速览

阶段: 4 期
状态: 撤回
发起方: Alcon Research
试验地点: 2
主要终点: Corneal astigmatism; IOL rotation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 40 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.

排除标准

•Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.

结局指标

主要结局

Corneal astigmatism; IOL rotation

时间窗: Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.

次要结局

Uncorrected and best distance corrected visual acuities (UCVA and BDCVA)(Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye.)

研究者

发起方

Alcon Research

申办方类型

Industry

研究点 (2)

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