The effect of intravitreal anti-vascular endothelial growth factor injection on intraocular pressure for retinopathy of prematurity
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean change in IOP measured by iCare tonometer at 5 minutes, 15 minutes or until IOP normalizes, on post injection day 1 in the eye receiving intravitreal anti-VEGF injection of ranibizumab under topical anesthesia.
研究概览
简要总结
This is a prospective interventional study to evaluate the effect of intravitreal Ranibizumab injection on intraocular pressure in premature infants with retinopathy of prematurity The primary outcome is to evaluate the change in intraocular pressure before and after injection and during follow-up up to 3 months. Secondary outcomes include the treatment response in terms of regression or progression of disease and the influence of maternal and neonatal risk factors
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0.00 Day(s) 至 2.00 Year(s)（—）
- 性别
- All
入选标准
- •Aggressive ROP (AROP) Zone 1 any stage with plus disease Zone 2 stage2/3 with plus disease.
排除标准
- •Prior history of anti-VEGF injection • Prior treatment with laser for ROP • Any Known hypersensitivity for anti-VEGF injection.
结局指标
主要结局
Mean change in IOP measured by iCare tonometer at 5 minutes, 15 minutes or until IOP normalizes, on post injection day 1 in the eye receiving intravitreal anti-VEGF injection of ranibizumab under topical anesthesia.
时间窗: 5 minutes | 15 minutes | post injection Day 1
次要结局
- 1. Mean change in IOP measured by iCare tonometer at 1 & 3 months in the eye receiving intravitreal anti-VEGF injection of Ranibizumab under topical anesthesia.(2. Response to treatment in terms of serial change in zone & stage of ROP from baseline with or without additional treatment.)
研究者
Dr Siddharth Madan
Guru Nanak Eye Centre