Prospective Randomized Controlled Study Measuring Posterior Capsular Opacification, Lens Glistenings, Tilt and Decentration, and Visual Outcomes Following Insertion of the RayOne Hydrophobic Lens 800C and the RayOne Hydrophilic Lens 600C.
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 主要终点
- Posterior Capsular Opacification of Intraocular Lens
研究概览
简要总结
A prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C and a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C
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
- Single (Participant)
盲法说明
Patients randomised into one of two groups
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral or bilateral cataracts requiring surgical intervention
- •Age over 18 years
- •Able to understand informed consent and the objectives of the trial
- •Not pregnant, not breast feeding
- •No previous eye surgery
- •Corneal astigmatism less than 1 diopter in both eyes.
排除标准
- •age-related macula degeneration
- •previous retinal vascular disorders
- •previous retinal detachment or tear
- •any neuro-ophthalmological condition
- •any inherited retinal disorder or pathology
- •previous strabismus surgery or record of amblyopia
- •previous TIA, CVA or other vaso-occlusive disease
- •already enrolled in another study
研究组 & 干预措施
RayOne® Hydrophilic lens 600C
Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C
干预措施: RayOne® Hydrophilic lens 600C (Device)
RayOne® Hydrophobic lens 800C
Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C
干预措施: RayOne® Hydrophobic lens 800C (Device)
结局指标
主要结局
Posterior Capsular Opacification of Intraocular Lens
时间窗: 24 months
Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques
Intraocular lens glistenings
时间窗: 24 months
Degree of the intraocular lens glistenings will be quantified using digital analysis
Intraocular lens tilt and decentration
时间窗: 24 months
次要结局
- Visual Acuities(24 months)
- Forward light scatter and Contrast Sensitivity Measurement(24 months)
- Patient Satisfaction(24 months)
- Intraoperative and post operative complications(0 days-24 months)