Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- distant corrected near visual acuity
研究概览
简要总结
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
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 (Outcomes Assessor)
盲法说明
outcome assessor will be masked to the intraocular lens implanted.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- •Age 50-90
- •Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Preceding ocular surgery or trauma
- •Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
- •Uncontrolled systemic or ocular disease
结局指标
主要结局
distant corrected near visual acuity
时间窗: 6 months
Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
次要结局
未报告次要终点
研究者
Christina Leydolt
Assoc. Prof. PD Dr
Medical University of Vienna