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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
25
1 drop (6-7 μL) for 3 doses, 5 minutes' intervals
1 drop (28-34 μL) for 3 doses, 5 minutes' intervals
"Papageorgiou" General Hospital
Thessaloniki, Greece
Mydriatic efficacy: mm of pupil diameter (left and right eye)
Time frame: 45 minutes after the first drop instillation
Mydriatic efficacy: mm of pupil diameter (left and right eye)
Time frame: 90 minutes after the first drop instillation
Mydriatic efficacy: mm of pupil diameter (left and right eye)
Time frame: 120 minutes after the first drop instillation
Systemic side effects: measurements of Heart Rate (bpm)
Time frame: 45 minutes after the first drop instillation
Systemic side effects: measurements of Heart Rate (bpm)
Time frame: 90 minutes after the first drop instillation
Systemic side effects: measurements of Heart Rate (bpm)
Time frame: 120 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)
Time frame: 45 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)
Time frame: 90 minutes after the first drop instillation
Systemic side effects: measurements of oxygen saturation (SpO2) (%)
Time frame: 120 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 45 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time frame: 90 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time frame: 120 minutes after the first drop instillation
Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg)
Time frame: Hourly for the first 24 hours after mydriasis
Local side effects: periorbital pallor, eyelid swelling, flushing
Time frame: 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)
Time frame: 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
Time frame: Upon eye examination (45 to 90 minutes after the first drop)