Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- binocular Distance Corrected Near Visual Acuity (DCNVA)
研究概览
简要总结
This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.
详细描述
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cataracteous eyes with no comorbidity
- •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
- •Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
- •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)
- •Complicated surgery
结局指标
主要结局
binocular Distance Corrected Near Visual Acuity (DCNVA)
时间窗: 3 months postoperative
measured in logMAR
次要结局
- monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)(3 months postoperative)
- Contrast Sensitivity (mesopic and photopic)(3 months postoperative)
- monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)(3 months postoperative)
- monocular and binocular Uncorrected Near Visual Acuity (UNVA)(3 months postoperative)
- monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)(3 months postoperative)
- monocular and binocular Uncorrected Distance Visual Acuity (UDVA)(3 months postoperative)
- monocular and binocular Corrected Distance Visual Acuity (CDVA)(3 months postoperative)