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

• Status: Completed
• Trial end date: 2020-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aristotle University Of Thessaloniki
• Treatments: Oxymetazoline; Phenylephrine; Tropicamide

Criteria

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