Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    90
  • sponsor
    Aristotle University Of Thessaloniki
Updated on 27 October 2021

Summary

The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.

Description

A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops (6.5 L) will be instilled using a calibrated micropipette, while standard drops (28-34 L) will be instilled directly through the commercially available plastic multi-dose mydriatic dropper bottle.

Details
Condition Retinopathy of Prematurity
Treatment Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%, Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%
Clinical Study IdentifierNCT05043077
SponsorAristotle University Of Thessaloniki
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Preterm infants undergoing screening for ROP, i.e
infants with GA < 32 weeks and/or BW < 1501 grams
infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist

Exclusion Criteria

Unstable clinical condition
Severe cardiovascular disease
Congenital anomalies
Clinical syndromes
Inotropes' intake during the week prior to enrollment
Traumatic apoptosis of the corneal epithelium
Corneal ulcer
Anatomical variations of the anterior segment
Infants that are outpatients at the commencement of ROP screening
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