Outcomes of topical Ringers Lactate solution as treatment for Phase – 1 Retinopathy of Prematurity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
研究概览
简要总结
Four preterm neonates were enrolled in the study. Among the four neonates, one developed Staged ROP (Phase 2) approximately two weeks earlier in the untreated eye compared to the treated eye. Two neonates showed simultaneous progression to staged ROP in both eyes, and one neonate was lost to follow-up. No local or systemic adverse effects were observed during the study period. This pilot study demonstrates a favorable local and systemic safety profile of topical Ringer’s lactate. However, further studies, including dose-escalation trials with larger sample sizes, are required to evaluate its efficacy in preventing progression from Phase 1 to Phase 2 ROP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.50 Month(s) 至 7.50 Month(s)(—)
- 性别
- All
入选标准
- •Preterm neonates born between 26 to 30 weeks of gestational age.
排除标准
- •a)Preterm neonates with stages of Retinopathy of Prematurity b)Preterm neonates born between
- •30 weeks of gestational age c)Preterm neonates with any other fundus abnormality d)Systemically unstable neonates.
研究者
Dr Vignesh Elamurugan
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
