CompletedPhase 4

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

Greece83 participantsStarted 2021-09-07

Plain-language 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.

Who can participate

Age range30 Weeks – 36 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mydriatic efficacy: millimeters of horizontal pupil diameter.

Timeframe: 45 minutes after the first drop instillation.

Trial details

NCT IDNCT05043077

SponsorAristotle University Of Thessaloniki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-20

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