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.

Early Phase 1CompletedNCT06288321

The University of Hong Kong18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Interventions

Microdrop Mydrin-PDRUG

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-PDRUG

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

Outcomes

Primary Outcomes

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.

Time frame: From the start of pupil dilation to pupil examination which is around 2 to 3 hours

Secondary Outcomes

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.