NCT05136950招募中不适用
Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Incidence of glaucoma-related adverse events
研究概览
简要总结
To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia
详细描述
Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 months and 14 years
- •Had a primary diagnosis of congenital cataract.
- •Underwent cataract extraction between the ages of 2 and 24 months
排除标准
- •Primary IOL implantation
- •Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma)
- •Suture fixation for secondary IOL implantation
结局指标
主要结局
Incidence of glaucoma-related adverse events
时间窗: One year after surgery
The assessment of glaucoma-related adverse events is performed at one year after surgery
次要结局
- Incidence of glaucoma-related adverse events(Six months,three years, five years, ten years after surgery)
- Incidence of other adverse events(Six months,one year, three years, five years, ten years after surgery)
- Intraocular lens tilt(Six months,one year, three years, five years, ten years after surgery)
- Visual acuity(Six months,one year, three years, five years, ten years after surgery)
- Ocular refractive power(Six months,one year,three years, five years, ten years after surgery)
- Intraocular lens decentration(Six months,one year, three years, five years, ten years after surgery)
研究者
研究点 (1)
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