To compare outcomes of primary intravitreal Ranibizumab vs laser in treatment of zone 2 threshold Retinopathy of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- We assess for disease regression, progression or reactivation, extent of vascularization. We also assess the need for secondary intervention. We then compare these outcomes between groups which received primary intravitreal Ranibizumab vs laser in treatment of zone 2 threshold Retinopathy of Prematurity.
研究概览
简要总结
Retinopathy of prematurity is a neovascular retinal disorder of low-birth-weight premature babies that causes loss of vision by macular dragging and retinal detachment. ROP remains one of the leading causes of childhood blindness in both developed and developing countries.Threshold ROP is defined as 5 contiguous or 8 cumulative clock hours of stage 3 ROP in zone 1 or zone 2 with plus disease by ETROP guidelines5. It is a severe stage of ROP and has high risk of retinal detachment if left untreated.Argon and diode lasers are used to treat the avascular retina of threshold ROP. However, laser often leads to progression, need for additional treatment, and often ends in sequelae with vision reduction. Laser of the avascular retina has delayed effect and there is risk of progression. Primary Anti-VEGF injections can lead to rapid ROP regression without sequelae, with the benefit of additional revascularization, preventing need for additional treatment. There is a need to assess outcomes of primary Anti-VEGF vs laser in threshold ROP
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 5.00 Month(s)（—）
- 性别
- All
入选标准
- •Gestational Age less than 34 weeks
- •Birth weight less than 2000 grams
- •Bigger babies 34-36 weeks or more than 2kg if high risk for developing ROP
- •Threshold ROP.
- •Zone 2 Stage 3 ROP (5 Contiguous / 8 non contiguous clock hours) with plus disease
- •No previous ROP treatment.
排除标准
- •Zone I and Zone III disease
- •Zone 2 disease less than threshold criteria
- •Advanced stage disease (stage 4/ 5 ROP)
- •Any other ocular abnormality
- •Systemically unfit for procedure
- •Parents not providing consent for study.
结局指标
主要结局
We assess for disease regression, progression or reactivation, extent of vascularization. We also assess the need for secondary intervention. We then compare these outcomes between groups which received primary intravitreal Ranibizumab vs laser in treatment of zone 2 threshold Retinopathy of Prematurity.
时间窗: Follow up will be done at 1 week and then 2 weekly till 50 weeks PMA or complete disease regression
次要结局
- a- To study need for additional treatment in both groups(b- To study the extent of revascularization, reactivation, PAR requiring treatment)
研究者
Dr Iekshiytha K
AIIMS New Delhi