NCT03364972已完成不适用
A Randomised, Controlled Study to Compare Visual Performance, Refractive Outcome, Forward Light Scatter, Patient Satisfaction and Objective Measurement of Glistenings Following Insertion of Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00 Lenses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.
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
- Double (Participant, Outcomes Assessor)
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
- •bilateral cataracts
- •good visual potential
- •ability to understand informed consent and 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 transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease
- •already enrolled in another study
- •Exclusion criteria relate to clinical contraindications for Femtosecond Laser Assisted Cataract Surgery, such as:
- •Significant corneal opacities
- •Small pupils following pharmacological dilatation
- •Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine
研究组 & 干预措施
Experimental intraocular lens implant
Experimental
'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant
干预措施: Cataract surgery (Device)
Standard intraocular lens implant
Active Comparator
Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant
干预措施: Cataract surgery (Device)
结局指标
主要结局
Visual acuity
时间窗: 13 months
As measured by conventional LogMAR visual acuity charts
次要结局
- Incidence of intraocular lens glistenings(13 months)
- Refraction (i.e. glasses prescription)(13 months)
- Severity of intraocular lens glistenings(13 months)
研究者
研究点 (1)
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