Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial

Phase 4

Completed

• Conditions: Retinopathy of Prematurity

• Registration Number: NCT04623684
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2020-03-24
• Primary Completion: 2020-09-22
• Study Completion: 2020-09-29
• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mydriatic efficacy: mm of pupil diameter (left and right eye)	90 minutes after the first drop instillation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

"Papageorgiou" General Hospital; 🇬🇷 Thessaloníki, Greece