A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Posterior Capsule Opacification Evaluation
研究概览
简要总结
To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL);
- •Pupil dilation ≧7 mm after mydrisis;
- •Patient undergoing cataract surgery for the first eye;
- •VA prognosis ≧6/12
排除标准
- •Patients with history of ocular pathology or diabetic retinopathy;
- •Patients with traumatic, subluxated and posterior polar cataract;
- •Patients had ocular surgery in the past 6 months;
- •Patients with significant intra-operative complications
研究组 & 干预措施
Phaco
Cataract extraction surgery utilizing Phacoemulsification
干预措施: Phacoemulsification cataract extraction surgery (Procedure)
SICS
Small incision cataract surgery (SICS)
干预措施: Small incision cataract surgery (Procedure)
结局指标
主要结局
Posterior Capsule Opacification Evaluation
时间窗: 12 months after surgery
The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.
次要结局
- Corneal Astigmatism(3 months after surgery)