NCT02990689已完成不适用
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
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
- 55
- 主要终点
- Intermediate visual acuity
研究概览
简要总结
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of any gender, aged 50 to 80 years
- •Signed informed consent form
- •Healthy eyes besides cataract
- •Assured follow-up examinations
- •Stable corneal conditions within the last 12 months
- •Corneal astigmatism less than 1D
- •Implantation into the capsular bag by injector
排除标准
- •Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- •Pseudophakia
- •Cornea guttata; keratoplasty
- •Irregular astigmatism (e.g. Keratoconus)
- •Corneal scarring
- •Diabetic retinopathy
- •Amblyopia
- •Amotio operation; anamnesis with vitreous surgery
- •Pseudoexfoliation Syndrome; Uveitis
- •Previous intraocular and corneal surgery
- •Intraocular tumours; endotamponade
- •Glaucoma or IOP higher than 24mmHg
- •Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
- •Need for a dioptre out of the range of +16.0D to +26.0D
- •Inability to achieve secure lens placement in the capsular bag
- •Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- •Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
- •Pregnancy or lactation period for female patients
研究组 & 干预措施
809M
Active Comparator
bifocal intraocular lens (IOL)
干预措施: Bifocal Intraocular Lens (Device)
839MP
Active Comparator
trifocal intraocular lens (IOL)
干预措施: Trifocal Intraocular Lens (Device)
SN6AD1
Active Comparator
bifocal intraocular lens (IOL)
干预措施: Low Addition Bifocal Intraocular Lens (Device)
结局指标
主要结局
Intermediate visual acuity
时间窗: 12 months
次要结局
- Distance visual acuity(12 months)
- Near visual acuity(12 months)
研究者
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