Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
研究概览
简要总结
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
详细描述
This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.
The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication 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
- 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
- •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
- •Irregular astigmatism
- •Age of patient < 50 years
- •Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
- •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)
- •AMD suspicious eyes (determined by OCT)
- •Complicated surgery
研究组 & 干预措施
IOL implantation active comparator
hydrophilic, trifocal intraocular lens POD F
干预措施: IOL implantation active comparator (Device)
IOL implantation experimental
hydrophobic, trifocal intraocular lens POD F GF
干预措施: IOL implantation experimental (Device)
结局指标
主要结局
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
时间窗: 3 months postoperative
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
次要结局
- Manifested refraction - Sphere(3 months postoperative)
- Manifested refraction - Cylinder(3 months postoperative)
- Uncorrected Distance Visual Acuity (UDVA)(3 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)(3 months postoperative)
- Distance Corrected Near Visual Acuity at 40cm (DCNVA)(3 months postoperative)
- Aberrometry - Tilt(3 months postoperative)
- OQAS II - OSI(3 months postoperative)
- Corrected Distance Visual Acuity (CDVA)(3 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)(3 months postoperative)
- Distance Corrected Near Visual Acuity at 25cm (DCNVA)(3 months postoperative)
- Halometry(3 months postoperative)
- Contrast Sensitivity(3 months postoperative)
- Aberrometry - SA(3 months postoperative)
- Aberrometry - HOA(3 months postoperative)
- OQAS II - MTF(3 months postoperative)
- OQAS II - Strehl Ratio(3 months postoperative)
- questionnaire(3 months postoperative)