NCT05043077

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

Name: Clinical Trial NCT05043077
Creator: Aristotle University Of Thessaloniki
Keywords: Retinopathy of Prematurity, Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%, Phase 4, drug, clinical trial, Greece

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening: a Non-inferiority Crossover Randomized Controlled Trial (MyMiROPS Trial)

Aristotle University Of Thessaloniki·Phase 4·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Retinopathy of Prematurity
Drug/Device/Intervention: Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Aristotle University Of Thessaloniki
Location: Thessaloníki, Greece

Timeline & enrollment

Phase: Phase 4
Start date: Sep 07, 2021
End date: Dec 15, 2022
Enrollment: 90 participants

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

Retinopathy of prematurityOther proliferative retinopathyBackground retinopathy and retinal vascular changesDiabetic retinopathyRetinal disorder, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05043077
Type: Non-Device Trial

About this record

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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