Clinical trial 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of prematurity
Preterm
Retinopathy of prematurity screening
Microdrops
Mydrin P
Mydriatics
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 (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.


Eligibility criteria: Inclusion Criteria:

* Neonates with estimated gestational age (EGA) at birth ≤32 weeks
* Neonates with birth weight ≤1500g

Exclusion Criteria:

* Neonates with severe clinical condition with unstable vital signs
* Neonates with congenital anomalies, syndromic disease
* Neonates with ophthalmological conditions such as eye infections, congenital eye anomalies, trauma
* Neonates with conditions that are contraindicated to mydriatic use

Primary outcomes:
measure: Successfulness of a ROP exam
timeFrame: From the start of pupil dilation to pupil examination which is around 2 to 3 hours
Secondary outcomes:
measure: Pupil diameters
timeFrame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
measure: Heart rate
timeFrame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
measure: Blood pressure
timeFrame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
measure: Oxygen saturation
timeFrame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
measure: Oxygen requirement
timeFrame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
measure: Episodes of vomiting
timeFrame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
measure: Volume of gastric residuals
timeFrame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
measure: Episodes of apnoea
timeFrame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
measure: Episodes of periorbital blanching
timeFrame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital
Study officials:
affiliation: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital
name: Khair Jalal
role: STUDY_CHAIR
References: