Randomized Controlled Trial Comparing the Efficacy and Safety of Mydriatic Microdrops Over Standard Dose Mydriatics for Pupil Dilation in Retinopathy of Prematurity Examination
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Successfulness of a ROP exam
研究概览
简要总结
A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.
Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.
A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.
Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates with estimated gestational age (EGA) at birth ≤32 weeks
- •Neonates with birth weight ≤1500g
排除标准
- •Neonates with severe clinical condition with unstable vital signs
- •Neonates with congenital anomalies, syndromic disease
- •Neonates with ophthalmological conditions such as eye infections, congenital eye anomalies, trauma
- •Neonates with conditions that are contraindicated to mydriatic use
研究组 & 干预措施
Standard Mydrin-P Group
Subjects allocated to the Standard Mydrin P group will receive standard Mydrin-P (0.5% tropicamide / 0.5% phenylephrine HCl) which is the standard eyedrops used for dilation of pupil before retinopathy of prematurity examination.
干预措施: Standard Mydrin-P (Drug)
Microdrop group
Those allocated to the microdrop group will receive microdrop Mydrin-P for pupil dilation before retinopathy of prematurity exam.
干预措施: Microdrop Mydrin-P (Drug)
结局指标
主要结局
Successfulness of a ROP exam
时间窗: From the start of pupil dilation to pupil examination which is around 2 to 3 hours
Primary outcome of the study was whether the ROP screening was successfully performed or not without additional eyedrops defined by the ophthalmologist conducting the exam.
次要结局
- Oxygen saturation(From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.)
- Pupil diameters(From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.)
- Heart rate(From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.)
- Blood pressure(From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.)
- Oxygen requirement(From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.)
- Episodes of vomiting(From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.)
- Volume of gastric residuals(From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.)
- Episodes of apnoea(From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.)
- Episodes of periorbital blanching(From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.)
研究者
Lu Evelyn Ruoyun
Doctor
The University of Hong Kong