The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual axis obscuration
研究概览
简要总结
The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.
This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients younger than 2 years of age
- •Unilateral or bilateral congenital cataracts compromising the red reflex
排除标准
- •Corneal opacity
- •Subluxated cataract
- •Traumatic cataract
- •Complex microphthalmia
- •Persistant hyperplastic primary vitreous
- •Retinal detachment
- •Patients with intraoperative complications, such as IOL implanted in the sulcus
研究组 & 干预措施
Prednisolone syrup
The control group will receive prednisolone syrup postoperatively
干预措施: Prednisolone syrup (Drug)
Triamcinolone acetonide
The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
Visual axis obscuration
时间窗: 1 year after surgery
Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.
Intraocular pressure
时间窗: 1 year after surgery
次要结局
未报告次要终点