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.
- Conditions
- Retinopathy of Prematurity
- Interventions
- Drug: Standard Mydrin-PDrug: Microdrop Mydrin-P
- Registration Number
- NCT06288321
- Lead Sponsor
- The University of Hong Kong
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Neonates with estimated gestational age (EGA) at birth ≤32 weeks
- Neonates with birth weight ≤1500g
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Mydrin-P Group Standard Mydrin-P 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. Microdrop group Microdrop Mydrin-P Those allocated to the microdrop group will receive microdrop Mydrin-P for pupil dilation before retinopathy of prematurity exam.
- Primary Outcome Measures
Name Time Method Successfulness of a ROP exam 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 Outcome Measures
Name Time Method Oxygen saturation 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.
Pupil diameters 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.
Heart rate 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.
Blood pressure 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.
Oxygen requirement 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.
Episodes of vomiting 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
Volume of gastric residuals 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
Episodes of apnoea 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
Episodes of periorbital blanching 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
Trial Locations
- Locations (1)
Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong