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Completed

NCT Number: NCT06288321

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.

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Retinal Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Mydrin-P

Drug

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

Primary outcomes

  1. Successfulness of a ROP exam

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

    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.

Secondary outcomes

  1. Pupil diameters

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

    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.

  2. Heart rate

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

    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.

  3. Blood pressure

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

    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.

  4. Oxygen saturation

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

    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.

  5. Oxygen requirement

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

    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.

  6. Episodes of vomiting

    Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.

    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

  7. Volume of gastric residuals

    Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.

    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

  8. Episodes of apnoea

    Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.

    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

  9. Episodes of periorbital blanching

    Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.

    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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Randomized Controlled Trial Comparing the Efficacy and Safety of Mydriatic Microdrops Over Standard Dose Mydriatics for Pupil Dilation in Retinopathy of Prematurity Examination

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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