Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Macular edema response rate
研究概览
简要总结
This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
详细描述
This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with familial exudative vitreoretinopathy
- •Needing diode laser photocoagulation
- •Consent to the study
排除标准
- •History of corneal diseases
- •History of hypersensitivity to bromfenac sodium
- •History of hypersensitivity to non-steroidal anti-inflammatory drugs
- •Progressive ocular infection
- •Liver diseases
- •Hypersensitivity to sulfur dioxide
- •Receiving anti-coagulation drugs
- •History of coagulopathies
研究组 & 干预措施
Bromfenac sodium hydrate eye drops
The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.
干预措施: Bromfenac Sodium (Drug)
结局指标
主要结局
Macular edema response rate
时间窗: 4 weeks after the diode laser photocoagulation
Presence of macular edema
次要结局
- Conjunctival injection response rate(4 weeks after the diode laser photocoagulation)
研究者
Jeong Hun Kim
Professor
Seoul National University Hospital