Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
研究概览
简要总结
The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
详细描述
Adequate pupil dilatation was needed for screening and treatment of retinopathy of prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were instilled many times until the pupil reached the maximum size. However, poor mydriasis were found in many eyes despite maximum instillation was used. From the clinical observation, we found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to dilate the pupil than instillation in some patients. The purpose of this study was to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
- •stable clinical course
排除标准
- •history of intraocular surgery or laser treatment
- •previous eyedrop instillation that might affect the pupil size
- •severe underlying disease or unstable clinical course that mydriatic drugs or the examination could aggravate their conditions
研究组 & 干预措施
1
Lower conjunctival fornix packing arm. For the eyes receiving lower conjunctival fornix packing (study group), one small piece of the cotton wool soaked with one drop of 2.5% phenylephrine and one drop of 1% tropicamide was packed in the lower conjunctival fornix.
干预措施: 1% tropicamide and 2.5% phenylephrine (Drug)
2
Conventional instillation arm. For the eyes receiving the instillation (control group), 2.5% phenylephrine and 1% tropicamide were alternately instilled every 5 minutes for two doses each.
干预措施: 1% tropicamide and 2.5% phenylephrine (Drug)
结局指标
主要结局
The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
时间窗: 40 minutes after mydriatric drugs
次要结局
未报告次要终点
研究者
Yosanan Yospaiboon
Professor
Khon Kaen University