Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening: a Non-inferiority Crossover Randomized Controlled Trial (MyMiROPS Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Mydriatic efficacy: millimeters of horizontal pupil diameter.
研究概览
简要总结
The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.
详细描述
A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops (6.5 μL) will be instilled using a calibrated micropipette, while standard drops (28-34 μL) will be instilled directly through the commercially available plastic multi-dose mydriatic dropper bottle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants undergoing screening for ROP, i.e.
- •infants with GA < 32 weeks and/or BW < 1501 grams
- •infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist
排除标准
- •Unstable clinical condition
- •Severe cardiovascular disease
- •Congenital anomalies
- •Clinical syndromes
- •Inotropes' intake during the week prior to enrollment
- •Traumatic apoptosis of the corneal epithelium
- •Corneal ulcer
- •Anatomical variations of the anterior segment
- •Infants that are outpatients at the commencement of ROP screening
研究组 & 干预措施
Study Group
Mydriasis with microdrops
干预措施: Microdrop administration of phenylephrine 1.67% and tropicamide 0.33% (Drug)
Control Group
Mydriasis with standard drops
干预措施: Standard drop administration of phenylephrine 1.67% and tropicamide 0.33% (Drug)
结局指标
主要结局
Mydriatic efficacy: millimeters of horizontal pupil diameter.
时间窗: 45 minutes after the first drop instillation.
次要结局
- Heart rate values (beats per minute).(45, 90 and 120 minutes after the first drop instillation.)
- Pharmacokinetic profile of phenylephrine: maximum (peak) whole blood concentration (Cmax).(Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.)
- Mydriasis sustainability: millimeters of horizontal pupil diameter.(120 minutes after the first drop instillation.)
- Pharmacokinetic profile of phenylephrine: time to reach maximum (peak) whole blood concentration (Tmax).(Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.)
- Pharmacokinetic profile of phenylephrine: elimination half-life (T1/2).(Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.)
- Number of participants with local adverse events.(45 minutes after the first drop instillation.)
- Adequacy of judging the presence or absence of treatment-requiring ROP.(At the end of the eye examination (fundoscopy).)
- Pharmacokinetic profile of phenylephrine: area under the whole blood concentration versus time curve (AUC).(Blood sampling at 15, 20, 25, 30, 40, 50, 60, 120, and 180 minutes after the first drop instillation.)
- Oxygen saturation (SpO2) values (%).(45, 90 and 120 minutes after the first drop instillation.)
- Systolic, diastolic, and mean blood pressure values (mmHg).(45, 90 and 120 minutes after the first drop instillation. Hourly blood pressure measurements for the first 24 hours after mydriasis.)
- Number of participants with systemic adverse events.(During the 48 hours after mydriasis.)
研究者
Asimina Mataftsi
Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus
Aristotle University Of Thessaloniki