NCT00708331撤回不适用
SC25-FOLD Hydrophilic Acrylic Intraocular Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 18
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic Intraocular Lens after cataract surgery
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye
- •The patient is willing and able to complete all required postoperative visits.
- •The patient is willing to sign a statement of informed consent.
- •Preoperative
排除标准
- •The patient is under the age of 18
- •The patient has had prior intraocular surgery in the operative eye.
- •The patient has systemic diseases with ocular manifestations (e.g. diabetes, complications of immune deficiency syndrome), which may contribute to postoperative confounding of data interpretation.
- •The patient's worst seeing eye is 20/70 or worse.
- •The patient has multiple surgical procedures at the time of implant.
- •The patient has chronic use of steroids, immunosuppressive and/or antineoplastic agents.
- •The patient has acute infection, inflammation of the eye.
- •Iris atrophy
- •Proliferative diabetic retinopathy.
- •Chronic, medically uncontrolled glaucoma
- •Chronic uveitis, iritis, iridocyclitis or rubeosis of the lids
- •Rubella, traumatic or congenital/developmental cataract.
- •Severe retinal pathology (e.g. retinal tear, detachment, etc).
- •Operative Patient Exclusion Criteria
- •Capsular rupture
- •Vitreous loss
- •Zonular disinsertion
- •Surgical Complications- In the event of a complication during surgery, the surgeon should decide whether the stability of the hydrophilic acrylic lens would be compromised by the complication, e.g. in the event of zonular damage of major capsule rupture. If the lens stability would be compromised, the hydrophilic acrylic lens should not be implanted and the surgeon should make arrangements to implant an alternative lens.
结局指标
主要结局
Visual Acuity
时间窗: At all pre/post op CRFs for 2 yrs
次要结局
- Adverse Events(2yrs)
研究者
研究点 (18)
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