NCT02618018Unknown不适用
An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual acuity, refractive results
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.
详细描述
Inclusion criteria
- senile cataract
- patients' age of 21 years or older
- preoperative regular corneal astigmatism between 1.00 D and 6.00 D
Exclusion criteria
- pregnant, lactating women
- presence of other ocular diseases which affect stability of lens capsule
Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •senile cataract
- •patients' age of 21 years or older
- •preoperative regular corneal astigmatism between 1.00 D and 6.00 D
排除标准
- •pregnant, lactating women
- •presence of other ocular diseases which affect stability of lens capsule
研究组 & 干预措施
intraocular lens
Experimental
AT TORBI 709M toric intraocular lens
干预措施: AT TORBI 709M (Procedure)
结局指标
主要结局
Visual acuity, refractive results
时间窗: 3 months
uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry
次要结局
- Cornea thickness(3 months)
- Rotational stability(3 months)
- Endothelial cell count(3 months)
研究者
研究点 (2)
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