Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Best corrected distance visual acuity (CDVA)
研究概览
简要总结
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
详细描述
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxBoost intraocular lenses.
The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.
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
- 否
入选标准
- •Subject aged 50 or over on the day of inclusion, presenting a
- •bilateral cataract for which posterior chamber IOL implantation
- •has been planned.
- •Fit within the available IOL diopter range.
- •Have had no previous refractive surgery.
- •Regular corneal astigmatism < 1 dioptre by an automatic
- •keratometer (regularity measured by topographer).
- •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
- •Subjects suffering from diagnosed degenerative visual disorders
- •Pre-existing ocular pathology
- •Acute or chronic disease or illness that would increase risk or confound study results
- •Axial lengths and keratometry such as the IOL spherical power is
- •not in the range of 14 to 28 D
- •Instability of keratometry or biometry measurements
- •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
研究组 & 干预措施
LuxGood group
the control group will receive the LuxGood parent intraocular lens.
干预措施: LuxGood IOL (Device)
LuxBoost Group
the experimental group will receive the LuxBoost intraocular lens.
干预措施: LuxBoost IOL (Device)
结局指标
主要结局
Best corrected distance visual acuity (CDVA)
时间窗: 4/6 months after surgery
To demonstrate the non-inferiority of LuxBoost IOL compared with the LuxGood monofocal control lens in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
次要结局
- Uncorrected Distance Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA), Distance Corrected Intermediate Visual Acuity (DCIVA), Uncorrected Near Visual Acuity (UNVA), Distance Corrected Near Visual Acuity (DCNVA)(4/6 months after surgery)
- Defocus curve(4/6 months after surgery)