NCT03242486已完成不适用
Safety and Effectiveness Evaluation of Toric Intraocular Lens
Nidek Co. LTD.0 个研究点目标入组 64 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- Visual acuity
研究概览
简要总结
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
详细描述
Effectiveness
- primary endpoint is visual acuity with pre-determined spherical correction.
- secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation
Safety
- number and percentage of adverse event
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age of 40 years or older
- •Patients with age-related cataract in one eye or both eyes.
- •Patients willing to participate in the required postoperative study.
- •Patient who can understand and sign the consent document.
- •An eye whose pupil diameter after mydriasis is 5 mm or greater.
- •An eye whose preoperative corneal cylindrical power is 1.0D or more.
- •An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
- •An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.
排除标准
- •Disorder of corneal endothelium
- •Uncontrolled glaucoma
- •Active Uveitis
- •Diabetic retinopathy
- •Retinal detachment
- •Congenital ocular anomalies
- •Choroidal hemorrhage
- •Shallow anterior chamber
- •Microphthalmus
- •Corneal dystrophy
- •Optic atrophy
- •Ocular hypertension
- •Amblyopia
- •Previous history of corneal transplantation
- •Active Iritis
- •Corneal disorder
- •Macular degeneration
- •Retinal degeneration
- •Clinically significant change in macula and/or retinal pigment epithelium
- •Corneal irregular astigmatism
- •Atopic disease
- •Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)
- •Pseudo-exfoliation syndrome
- •Iris neovascularization
- •Long axis length eye (axis length : 28mm or more)
- •Severe dry eye, abnormality of the lens surface
- •Concurrent participation in another drug and device clinical investigation
- •Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial
- •Patient who is judged inappropriate by investigators or sub-investigators
研究组 & 干预措施
toric intraocular lens
Experimental
toric intraocular lens is implanted to all subjects
干预措施: toric intraocular lens (Device)
结局指标
主要结局
Visual acuity
时间窗: postoperative 6 months
Visual acuity with pre-determined spherical correction
次要结局
- IOL rotation(postoperative 6 months)
- Visual acuity(postoperative 6 months)
研究者
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