Development of a Database (Register) for Quality Assurance and Optimization of the Postoperative Results of Premium Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 8
- 主要终点
- Monocular Best corrected distance visual acuity (5 m)
研究概览
简要总结
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.
详细描述
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.
Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak & Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.
Main objectives:
- Functional results (refraction and visual acuity results) Secondary goals:
- Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
- Subjective patient satisfaction
- Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
- Stability of the results achieved postoperatively
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Monocular Best corrected distance visual acuity (5 m)
时间窗: Postoperative Day 75-105 (3 months)
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
次要结局
未报告次要终点