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NCT06288321

A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity.

Randomized Controlled Trial Comparing the Efficacy and Safety of Mydriatic Microdrops Over Standard Dose Mydriatics for Pupil Dilation in Retinopathy of Prematurity Examination
The University of Hong Kong·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Retinopathy of Prematurity
Drug/Device/Intervention
Microdrop Mydrin-P
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
The University of Hong Kong
Location
Hong Kong, China
Timeline & enrollment
Phase
Phase 1
Start date
Aug 10, 2022
End date
Mar 22, 2023
Enrollment
18 participants
Primary outcome

Successfulness of a ROP exam

Summary

A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in
 the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was
 to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P
 eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams,
 also to ascertain the optimal time for eye examination after administration of mydriatics and
 assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ
 between microdrops and standard dose Mydrin-P.
 
 Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the
 mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The
 primary outcome measured whether a successful ROP examination was conducted. Secondary
 outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after
 eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the
 mydriatics administration.
 
 A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded.
 All episodes with microdrops instillation led to successful ROP exams. There was no
 statistically significant difference between standard eyedrops and microdrops in determining
 the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops
 and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in
 the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam
 was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in
 the occurrence of systemic side effects when compared to standard Mydrin P drops.
 
 Hence the study concluded that microdrops have similar efficacy and safety profile compared
 to standard Mydrin-P eyedrops.

ICD-10 classifications
Retinopathy of prematurityOther proliferative retinopathyBackground retinopathy and retinal vascular changesDiabetic retinopathyRetinal disorder, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06288321
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06288321 through Pure Global AI's free database. This Phase 1 trial is sponsored by The University of Hong Kong and is currently Completed. The study focuses on Retinopathy of Prematurity. Target enrollment is 18 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.