protocolSection identificationModule nctId: NCT06288321, orgStudyIdInfo id: UW22221, briefTitle: 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., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-10, primaryCompletionDateStruct date: 2023-03-22, completionDateStruct date: 2023-03-22, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Retinopathy of Prematurity, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Microdrop Mydrin-P, interventions name: Standard Mydrin-P, outcomesModule primaryOutcomes measure: Successfulness of a ROP exam, secondaryOutcomes measure: Pupil diameters, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Oxygen requirement, secondaryOutcomes measure: Episodes of vomiting, secondaryOutcomes measure: Volume of gastric residuals, secondaryOutcomes measure: Episodes of apnoea, secondaryOutcomes measure: Episodes of periorbital blanching, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-07-14, uploadDate: 2024-02-18T04:50, filename: Prot_000.pdf, size: 94463, hasResults: False