Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening - Trial NCT05043077
Access comprehensive clinical trial information for NCT05043077 through Pure Global AI's free database. This Phase 4 trial is sponsored by Aristotle University Of Thessaloniki and is currently Recruiting. The study focuses on Retinopathy of Prematurity. Target enrollment is 90 participants.
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Study Focus
Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%
Interventional
drug
Sponsor & Location
Aristotle University Of Thessaloniki
Timeline & Enrollment
Phase 4
Sep 07, 2021
Dec 15, 2022
Primary Outcome
Mydriatic efficacy: millimeters of horizontal pupil diameter.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05043077
Non-Device Trial