Clinical Study to Compare Clinical Outcomes of Trifocal IOLs FineVision POD L GF and FineVision POD F GF After Bilateral Implantation in Asian Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
研究概览
简要总结
Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.
详细描述
This is a prospective, randomised, controlled, single-surgeon, single-center clinical 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 L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 6 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
- 40 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
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent
排除标准
- •Age of patient <40 years
- •Irregular astigmatism
- •Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
- •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)
结局指标
主要结局
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
时间窗: 3 months postoperative
No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.
次要结局
- Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions(6 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions(3 months postoperative)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions(6 months postoperative)
- Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions(3 months postoperative)
- Manifested refraction(3 months postoperative)
- Corrected Distance Visual Acuity (CDVA) under mesopic light conditions(6 months postoperative)
- Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(3 months postoperative)
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions(3 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions(6 months postoperative)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions(3 months postoperative)
- Aberrometry(3 months postoperative)
- Questionnaire VFQ-25 (National Eye Institute)(3 months postoperative)
- Corrected Distance Visual Acuity (CDVA) under photopic light conditions(3 months postoperative)
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions(6 months postoperative)
- Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions(6 months postoperative)
- Contrast Sensitivity(3 months postoperative)
- AcuTarget diagnostic device(3 months postoperative)
- Defocus Curve monocular(1 month postoperative)
- Defocus Curve binocular(3 months postoperative)