Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- RE
研究概览
简要总结
Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)
详细描述
Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch & Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •only adult men and women with aphakia without capsular support
排除标准
- •Fuchs' dystrophy
- •corneal haze or scarring
- •history of corneal transplantation
- •astigmatism of more than 2,0D
- •clinically active uveitis
- •advanced glaucoma
- •macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)
结局指标
主要结局
RE
时间窗: 12 months after surgery
Postoperative total refractive error
ECC
时间窗: before and 12 months after surgery
corneal endothelial cell density
BCVA
时间窗: before and 12 months after surgery
The change of best- corrected visual acuity
次要结局
- Number of complications(from day 1 until 12 months after surgery)