Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Posterior Capsule Opacification (PCO)
研究概览
简要总结
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years
- •Clear cornea
- •Pupil mydriasis ≥ 7mm
- •In the bag Intraocular Lens (IOL)
排除标准
- •Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
- •Previously operated eye
- •Proliferative diabetic retinopathy
- •Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis
研究组 & 干预措施
Model SN60WF
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
干预措施: Model SN60WF (Device)
Model MA60AC
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
干预措施: Model MA60AC (Device)
结局指标
主要结局
Posterior Capsule Opacification (PCO)
时间窗: Up to 3 years
Development of PCO using the EPCO Score. The EPCO score incorporates planimetric \& grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
次要结局
未报告次要终点