Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2.
研究概览
简要总结
The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC
详细描述
The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC This study includes both eyes of 24 patients implanted with the POD 26%FineVision Toric (group 1: 12 patients) and the POD 26% Toric (group 2: 12 patients) .
The study primary goal is to compare the near visual acuity in both groups. Distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patient older than 50 years old
- •Regular corneal astigmatism >1.0 dioptres by IOL Master (regularity determined by the topography of the keratometry).
- •Regular corneal astigmatism <2.5 dioptres by IOL Master (regularity determined by the topography of the keratometry).
- •Group 1: patients after cataract surgery with Fine Vision toric implanted in both eyes
- •Group 2: patients after cataract surgery with Ankoris implanted in both eyes
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
排除标准
- •- 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 abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- •IOL spherical equivalent power lower than 10 D or greater than 30D
- •Complicated surgery
结局指标
主要结局
The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2.
时间窗: 3 months
次要结局
- The secondary objective is to measure far and intermediate visual acuity, the refraction, centration, rotational stability and to determine the amount of photic phenomena for both IOLs: POD 26% FINEVISION TORIC and POD 26% TORIC.(3 months)