Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Mydriatic efficacy: mm of pupil diameter (left and right eye)
研究概览
简要总结
The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit.
详细描述
A pilot prospective randomized crossover clinical trial is conducted for assessing the mydriatic efficacy and safety of microdrops (6-7 μL) compared with standard drops (28-34 μL) for retinopathy of prematurity screening. A random number table was used to allocate participants into either a) receiving standard drop on their first and microdrop on their second screening examination a week later, or b) receiving microdrop first and standard drop a week later. The mydriatic agent contains phenylephrine 1.67% and tropicamide 0.33%, which derives from compounding the commercial phenylephrine 5% with the commercial tropicamide 0.5% in volume ratio 1:2.
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 37 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.
- •with gestational age (GA) < 32 weeks and/or birth weight (BW) < 1501 grams
- •infants of greater GA and BW with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc.
排除标准
- •Unstable clinical condition
- •Suspicion of cardiovascular disease
- •Severe congenital anomalies
- •Clinical syndromes
- •Traumatic apoptosis of the corneal epithelium
- •Corneal ulcer
- •Anatomical variations of the anterior segment
结局指标
主要结局
Mydriatic efficacy: mm of pupil diameter (left and right eye)
时间窗: 90 minutes after the first drop instillation
次要结局
- Mydriatic efficacy: mm of pupil diameter (left and right eye)(120 minutes after the first drop instillation)
- Systemic side effects: measurements of Heart Rate (bpm)(120 minutes after the first drop instillation)
- Systemic side effects: measurements of oxygen saturation (SpO2) (%)(120 minutes after the first drop instillation)
- Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)(Hourly for the first 24 hours after mydriasis)
- Local side effects: periorbital pallor, eyelid swelling, flushing(45 minutes after the first drop instillation)
- Adverse events including apnea, increased gastric residuals, inhibited duodenal motor activity, delayed gastric emptying, feeding intolerance, abdominal distension, vomiting, paralytic ileus, acute gastric dilatation and necrotizing enterocolitis (NEC)(During the 24 hours after mydriasis for ROP screening)
- Number of participants with non-adequate mydriasis to fully visualize peripheral fundus according to the examiner(Upon eye examination (45 to 90 minutes after the first drop))
研究者
Asimina Mataftsi
Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus
Aristotle University Of Thessaloniki