NCT01621789已完成3 期
A Descriptive Study to Evaluate the Efficacy of the Dye Compound of the Combination of Lutein, Zeaxanthin and Trypan Blue to Stain the Anterior Lens Capsule During Cataract Phacoemulsification.
Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Visibility of the anterior lens capsule after the injection of dye
研究概览
简要总结
Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.
详细描述
Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract surgery will be selected to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 50 years
- •Diagnosis of cataract (nuclear, entumecente, total)
- •Absence of red reflex
- •Indication of cataract surgery
排除标准
- •Posterior subcapsular cataract
- •Any history of eye disease
- •Eye infection affecting any structure prior ocular
- •Any previous ocular surgery
研究组 & 干预措施
dye of lutein, zeaxanthin, trypan blue
Experimental
during the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule
干预措施: dye of lutein, zeaxanthin, trypan blue (Other)
结局指标
主要结局
Visibility of the anterior lens capsule after the injection of dye
时间窗: during the cataract surgery
The visibility of the anterior lens capsule after the injection of dye, should be graduated as Bad OR Fair OR Good OR Fine
次要结局
- Degree of impregnation of the dye(during the surgery)
- usefulness of the dye(at the end of the cataract surgery)
研究者
Rubens Belfort Jr.
Full Professor of Ophthalmology
Federal University of São Paulo
研究点 (1)
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