Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288321
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2024-02-18
Brief Title:
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
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Randomized Controlled Trial Comparing the Efficacy and Safety of Mydriatic Microdrops Over Standard Dose Mydriatics for Pupil Dilation in Retinopathy of Prematurity Examination
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 p0233 Mean pupil diameter did not differ between the microdrops and standard eyedrops group At the time of ROP exam the mean pupil diameter was 547mm in the standard eyedrops group and 573mm 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
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 p0233 Mean pupil diameter did not differ between the microdrops and standard eyedrops group At the time of ROP exam the mean pupil diameter was 547mm in the standard eyedrops group and 573mm 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None