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.

NCT ID: NCT06288321

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-03-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Mydrin-P Group

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.

Group Type: PLACEBO_COMPARATOR

Standard Mydrin-P

Intervention Type: DRUG

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

Microdrop group

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

Group Type: EXPERIMENTAL

Microdrop Mydrin-P

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Standard Mydrin-P

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

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lu Evelyn Ruoyun

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khair Jalal

Role: STUDY_CHAIR

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital

Locations

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UW22221

Identifier Type: -

Identifier Source: org_study_id