An Early Phase 1 interventional study of Microdrop Mydrin-P and Standard Mydrin-P in Retinopathy of Prematurity, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by The University of Hong Kong · Early Phase 1, Interventional, and Other
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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.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's enrollment of 18 is below the median of 82 across 102 interventional studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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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.
Drug: Standard Mydrin-P
Those allocated to the microdrop group will receive microdrop Mydrin-P for pupil dilation before retinopathy of prematurity exam.
Drug: 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.
Standard Mydrin-P is the standard mydriatic used for retinopathy of prematurity exam as per our local usual practice.
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
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.
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Heart rate
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.
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Blood pressure
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.
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Oxygen saturation
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.
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Oxygen requirement
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.
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Episodes of vomiting
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
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Volume of gastric residuals
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
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Episodes of apnoea
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
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Episodes of periorbital blanching
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
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Plan to share: No
Ran from Aug 2022 to primary completion in Mar 2023, 7 months.
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