CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Status:
Terminated
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult
to obtain, because of the non mature iris sphincter. The fundus is essential to detect
retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim
of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two
mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study
will evaluate the mydriasis in premature newborns, neonates and infants justifying a
mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus
reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic
insert Mydriasert® can control drug dispensation and decrease the number of nurse
interventions to obtain mydriasis in patients.