Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 5
- 主要终点
- Distance Corrected Near Visual Acuity (DCNVA)
研究概览
简要总结
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
详细描述
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses.
The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation
- •No ocular comorbidity possibly affecting the study results
- •Fit within the available IOL diopter range
- •Have had no previous refractive surgery
- •Regular corneal astigmatism ≤1.0 dioptres
- •Clear intraocular media other than cataract
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Ability to attend all study follow-ups
- •Signed informed consent.
排除标准
- •Ocular surface disease potentially affecting study results
- •Pre-existing ocular pathology or history of pathology potentially affecting the study results
- •Acute or chronic disease or illness that would increase risk or confound study results
- •Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
- •Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
- •Instability of keratometry or biometry measurements
- •Traumatic cataract
- •Amblyopia
- •History of ocular trauma or any prior ocular surgery including refractive procedures
- •Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens
- •Pupil abnormalities
- •Systemic or ocular medication that could modify pupil dynamics
- •Expected complicated surgery or complicated surgery
- •Concurrent participation in another drug or device investigation
研究组 & 干预措施
LuxHighAdd
The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.
干预措施: LuxHighAdd IOL (Device)
LuxGood group
The control group will recieve the LuxGood intraocular lens bilaterally.
干预措施: LuxGood IOL (Device)
结局指标
主要结局
Distance Corrected Near Visual Acuity (DCNVA)
时间窗: 4/6 months after surgery
To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.
Best corrected distance visual acuity (BCDVA)
时间窗: 4/6 months after surgery
To demonstrate the non-inferiority of the Lux High Add lens compared with the monofocal control LuxGood lens in terms of BCDVA by means of statistical significance.
次要结局
- Manifest Refraction(4/6 months after surgery)
- Defocus curve(4/6 months after surgery)
- Adverse events rates(4/6 months after surgery)
- Uncorrected Distance Visual Acuity (UDVA)(4/6 months after surgery)
- Uncorrected Near Visual Acuity (UNVA)(4/6 months after surgery)
- Contrast Sensitivity(4/6 months after surgery)
- Patient-reported outcomes: Quality of vision Questionnaire(4/6 months after surgery)
- Patient-reported outcomes: open-ended question(4/6 months after surgery)
- Uncorrected Intermediate Visual Acuity (UIVA)(4/6 months after surgery)
- Distance Corrected Intermediate Visual Acuity (DCIVA)(4/6 months after surgery)
- Halo and glare scores(4/6 months after surgery)
- Patient-reported outcomes: Spectacle independance Questionnaire(4/6 months after surgery)