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.

NCT06288321 | Completed Early Phase 1

• 1 other identifier: UW22221
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of prematurity; Preterm; Retinopathy of prematurity screening; Microdrops; Mydrin P; Mydriatics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pupil diameters

  From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.

• Heart rate

  From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.

• Blood pressure

  From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.

• Oxygen saturation

  From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.

• Oxygen requirement

  From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.

Study Arms (2)

Standard Mydrin-P Group

PLACEBO COMPARATOR

Subjects allocated to the Standard Mydrin P group will receive standard Mydrin-P (0.5% tropicamide / 0.5% phenylephrine HCl) which is the standard eyedrops used for dilation of pupil before retinopathy of prematurity examination.

Drug: Standard Mydrin-P

Microdrop group

EXPERIMENTAL

Those allocated to the microdrop group will receive microdrop Mydrin-P for pupil dilation before retinopathy of prematurity exam.

Drug: Microdrop Mydrin-P

Interventions

Microdrop Mydrin-P DRUG

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.

Microdrop group

Standard Mydrin-P DRUG

Standard Mydrin-P is the standard mydriatic used for retinopathy of prematurity exam as per our local usual practice.

Standard Mydrin-P Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Premature Birth

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Khair Jalal

  Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 1, 2024
• Study Start: August 10, 2022
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)