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.

Retinopathy of Prematurity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06288321
• Other study ID #: UW22221
• Status: Completed
• Phase: Early Phase 1
• Start date: August 10, 2022
• Est. completion date: March 22, 2023

Study information

• Verified date: February 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mydriasis
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Microdrop Mydrin-P
Microdrop Mydrin-P consists of around one third of the standard Mydrin-P drop size. Drop volume measurement was performed using a precision weight scale (Sartorius) with accuracy up to 0.001g. The microdrop administration was conducted via attachment of a 16 gauge needle to a 1ml syringe.
• Standard Mydrin-P
Standard Mydrin-P is the standard mydriatic used for retinopathy of prematurity exam as per our local usual practice.

Locations

Country	Name	City	State
Hong Kong	Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successfulness of a ROP exam	Primary outcome of the study was whether the ROP screening was successfully performed or not without additional eyedrops defined by the ophthalmologist conducting the exam.	From the start of pupil dilation to pupil examination which is around 2 to 3 hours
Secondary	Pupil diameters	Pupil diameter (in millimetres, mm) was documented at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP). Two measurements were taken during each time, one by visual assessment, another one by pupillometer measurement.	From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Secondary	Heart rate	Heart rate at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.	From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Secondary	Blood pressure	Blood pressure at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.	From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Secondary	Oxygen saturation	Oxygen saturation at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.	From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Secondary	Oxygen requirement	Oxygen requirement at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.	From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Secondary	Episodes of vomiting	Episodes of vomiting were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure	From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Secondary	Volume of gastric residuals	Volume of gastric residuals were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure	From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Secondary	Episodes of apnoea	Episodes of apnoea were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure	From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Secondary	Episodes of periorbital blanching	Episodes of periorbital blanching were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure	From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.