Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Visual Acuity at far, near and intermediate distance
研究概览
简要总结
The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic).
To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.
详细描述
The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations.
Follow up will be up to 6 months postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Cataractous Eyes with no comorbidity
- •Patient older than 50 years old
- •Regular corneal astigmatism <0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or <1.0 dioptres if the steep axis of cylinder is between 90° and 120°
- •Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent
排除标准
- •Unrealistic expectation
- •Irregular astigmatism
- •Difficulty for cooperation (distance from their home, general health condition)
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
- •Any ocular comorbidity
- •History of ocular trauma or prior ocular surgery including refractive procedures
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
研究组 & 干预措施
IOL Implantation experimental
Implantation of POD F GF in one of the eyes of the study subject
干预措施: IOL implantation experimental (Device)
IOL Implantation Comparator
Implantation of POD F in the contralateral eye of the study subject
干预措施: IOL implantation comparator (Device)
结局指标
主要结局
Visual Acuity at far, near and intermediate distance
时间窗: 6 months postoperative
ability to read letters at different distances
次要结局
未报告次要终点