Efficacy and Tolerance of Ophthalmic Insert Mydriasert® Versus Reference Treatment (Phenylephrine and Tropicamide Eyedrops) in Premature Newborns, Neonates and Infants Justifying a Mydriasis for a Bilateral Diagnosis Fundus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
研究概览
简要总结
Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.
详细描述
The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring
- •Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).
- •Needing a bilateral fundus
- •Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.
- •Covered by French social security or CMU
排除标准
- •Neonates of less 1000g at inclusion
- •Premature newborn of less 30 weeks of gestational age at inclusion
- •Contra-indication to one of the evaluated drugs
- •Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study
- •Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician
研究组 & 干预措施
1
Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
干预措施: phenylephrine and tropicamide eyedrops (Drug)
2
Premature newborns and neonates treated using insert Mydriasert®
干预措施: Mydriasert® (Drug)
结局指标
主要结局
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
时间窗: 75 minutes
次要结局
- Frequency of the nurse intervention to obtain the mydriasis(during 215 minutes maximum)
- Calculation of the dose of active drugs administrated(one day)
- Local and systemic clinical tolerance(one day)
- Occurrence of adverse reactions(one day)
- Stability of a mydriasis of good quality at T+195(at T+195 minutes)