Retinopathy of Prematurity
Conditions
Keywords
microdrops, mydriasis, dilating drops, retinopathy of prematurity, ROP, screening
Brief summary
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.
Detailed description
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.
Interventions
DRUGMicrodrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)]
1 drop (6-7 μL) for 3 doses, 5 minutes' intervals
DRUGStandard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]
1 drop (28-34 μL) for 3 doses, 5 minutes' intervals
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Weeks to 37 Weeks
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mydriatic efficacy: mm of pupil diameter (left and right eye) | 45 minutes after the first drop instillation |
Secondary
| Measure | Time frame |
|---|---|
| Systemic side effects: measurements of Blood Pressure (Systolic, Diastolic and Mean Blood Pressure) (mmHg) | 45 minutes after the first drop instillation |
| 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) | 45 minutes after the first drop instillation |
| Systemic side effects: measurements of oxygen saturation (SpO2) (%) | 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) |
| Local side effects: periorbital pallor, eyelid swelling, flushing | 45 minutes after the first drop instillation |
Countries
Greece
Outcome results
None listed