NCT00571831已完成不适用
The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To measure FA, VEP and OCT.
研究概览
简要总结
To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).
详细描述
The following parameters were measured for evaluation of blood retinal barrier disruption.
- the incidence of macular leakage by fluorescence angiography (FA)
- the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
- the thickness of the macula by optical coherence tomography (OCT)
Results
- the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
- the VFP significantly decreased in both group from 3 to 12 months.
- the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 否
入选标准
- •cataract patients
- •All eligible for intraocular lens implantation
排除标准
- •Patients had undergone an intraocular operation
- •Patients had hypertensive retinopathy
- •Patients had diabetic retinopathy
- •Patients had ange-related macular degeneration
- •no observable fundus
- •The cataract operation was more than 30 minutes in duration
结局指标
主要结局
To measure FA, VEP and OCT.
时间窗: At 3 and 12 months after IOL implantation
次要结局
未报告次要终点
研究者
研究点 (2)
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