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Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

NCT05043077 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Microdrop administration of phenylephrine 1.67% and tropicamide 0.33%

1 drop (6.5 μL) for 3 doses with 5-minute intervals

DRUG

Standard drop administration of phenylephrine 1.67% and tropicamide 0.33%

1 drop (28-34 μL) for 3 doses with 5-minute intervals

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-07
Primary Completion
2023-01-20
Completion
2023-01-23

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043077 on ClinicalTrials.gov