Influence of Two Sharp-edged Hydrophobic Acrylic Micro-incision-IOLs on Posterior Capsule Opacification. A Randomized, Double-masked Study With Intraindividual Comparison.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PCO rate
研究概览
简要总结
Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits migration of lens epithelial cells in between posterior capsule and optic of the IOL and therefore reduces the rate of posterior capsule opacification (PCO). In present time most IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production different IOLs have different rates of PCO.
Progression in cataract surgery technique allow phacoemulsification through micro-incisions. Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.
This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp posterior optic edge on the rate of PCO after implantation through a micro-incision. The results will be compared intraindividually.
详细描述
prospective, randomized, bilateral study with intraindividual comparison, implantation of a Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye.
PCO rate will be detected at 1 year and 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral age-related cataract
- •age 55 to 80 years
- •expected postoperative visual acuity of at least 0.5
排除标准
- •amblyopia
- •corneal scars
- •pseudoexfoliation-syndrome
- •earlier ocular surgeries or laser treatments
- •intraocular tumors
结局指标
主要结局
PCO rate
时间窗: 2 years after surgery
次要结局
未报告次要终点