NCT00449267已完成4 期
Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.
详细描述
Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 65 years
- •Senile Cataract
- •Posterior Subcapsular Cataract (PSCC)
排除标准
- •Obviously debilitated patients
- •Cardiac and other serious illness
- •Diabetic Patients
- •Traumatic cataract
- •Complicated cataract
- •Congenital cataract
- •Drug induced cataract
- •Shallow anterior chamber
- •Poor mydriasis
- •Amblyopia
- •Pseudo exfoliation (PXF)
- •Dense posterior polar cataract (PPC)
- •One eyed patients
- •Corneal Pathology
- •Retinal Pathology
- •Intra operative complications like PC rupture, Zonular dialysis
结局指标
主要结局
Visual acuity
时间窗: 10days, 40 days, 150 days post operatively
次要结局
- Refraction(10days, 40 days, 150 days post operatively)
- Intraocular pressure(10days, 40 days, 150 days post operatively)
- Corneal status(10days, 40 days, 150 days post operatively)
- Iritis(10days, 40 days, 150 days post operatively)
- IOL decentration(10days, 40 days, 150 days post operatively)
- IOL tilt(10days, 40 days, 150 days post operatively)
- IOL discoloration(10days, 40 days, 150 days post operatively)
- IOL opacity(10days, 40 days, 150 days post operatively)
- Cystoid macular oedema(10days, 40 days, 150 days post operatively)
- Hypopyon(10days, 40 days, 150 days post operatively)
- Endophthalmitis(10days, 40 days, 150 days post operatively)
- Pupillary block(10days, 40 days, 150 days post operatively)
- Retinal detachment(10days, 40 days, 150 days post operatively)
- Status of anterior and posterior capsule(10days, 40 days, 150 days post operatively)
研究者
研究点 (2)
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