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.

The University of Hong Kong (HKU)

Status and phase: Completed; Early Phase 1

Conditions: Retinopathy of Prematurity

Treatments: Drug: Standard Mydrin-P; Drug: Microdrop Mydrin-P

Study type: Interventional

Funder types: Other

Identifiers

NCT06288321

UW22221

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Standard Mydrin-P Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Standard Mydrin-P

Microdrop group

Experimental group

Description:

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

Treatment:

Drug: Microdrop Mydrin-P