Efficacy and safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS): study protocol for a non-inferiority crossover randomized controlled trial
This report aims to present the fully developed protocol of a full-scale trial for testing the hypothesis that the reduced mydriatic drop volume achieves adequate mydriasis while minimizing systemic adverse events.MethodsA non-inferiority crossover randomized controlled trial will be performed to study the efficacy and safety of combined phenylephrine 1.67% and tropicamide 0.33% microdrops compared with standard drops in a total of 93 preterm infants requiring ROP screening. Primary outcome will be the pupil diameter at 45 (T45) min after instillation. Pupil diameter at T90 and T120 will constitute secondary efficacy endpo...
Source: Trials - April 15, 2022 Category: Research Source Type: clinical trials
Clinical Study of the Hyperviscosity Syndrome in Waldenstr öm Macroglobulinemia
Conditions: Hyperviscosity Syndrome; Waldenstrom Macroglobulinemia Interventions: Other: fundoscopic picture; Biological: blood sample; Procedure: bone marrow sample Sponsors: Centre Hospitalier Universitaire, Amiens; Centre Hospitalier Saint Vincent; Centre Henri Becquerel; University Hospital, Caen; University Hospital, Lille; Centre Hospitalier de Lens Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - May 24, 2021 Category: Research Source Type: clinical trials
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
Condition: Retinopathy of Prematurity Interventions: Other: Speculum-free (SpF) fundoscopy; Other: Speculum (Sp) fundoscopy Sponsor: Aristotle University Of Thessaloniki Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - May 29, 2020 Category: Research Source Type: clinical trials
