Clinical Study to Compare Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 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 clinical study to compare the clinical outcomes of two trifocal IOLs with different material (hydrophobic and hydrophilic) from the same manufacturer. 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 F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD F GF and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is the material (hydrophobic and hydrophilic). 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 12 study visits (1 preoperative, 2 operative and 9 postoperative) over a period of 36 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 and secondary endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. 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
- 45 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
- •Unrealistic expectation
- •Age of patient <45 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)
- •Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)
- •Complicated surgery
结局指标
主要结局
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
时间窗: 3 months postoperative
No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
次要结局
- Manifested refraction(Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Corrected Distance Visual Acuity (CDVA) - monocular(Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Aberrometry(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- AcuTarget diagnostic device(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - Pupillary block(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular(1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Uncorrected Near Visual Acuity at 35cm (UNVA)(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Defocus Curve(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - Corneal Status(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - Signs of inflammation(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Uncorrected Distance Visual Acuity (UDVA) - binocular(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Corrected Distance Visual Acuity (CDVA) - binocular(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Contrast Sensitivity(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - Fundus(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - IOL decentration(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular(1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular(1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - Retinal detachment(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - Status of anterior and posterior capsule(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Uncorrected Distance Visual Acuity (UDVA) - monocular(1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Visual Functioning Questionnaire - 25 (VFQ-25)(3 months postoperative, 12 months postoperative.)
- Slitlamp examination - IOL tilt(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - IOL opacity(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)
- Slitlamp examination - IOL discoloration(3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.)