Trial | NCT00642135  Report issue

Title

CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Efficacy and Tolerance of Ophthalmic Insert Mydriasert® Versus Reference Treatment (Phenylephrine and Tropicamide Eyedrops) in Premature Newborns, Neonates and Infants Justifying a Mydriasis for a Bilateral Diagnosis Fundus

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    80
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.
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.
Study Started
Jan 31
2006
Primary Completion
Feb 29
2008
Anticipated
Study Completion
Jun 30
2008
Anticipated
Last Update
Apr 10
2008
Estimate

Drug Mydriasert®

Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

Drug phenylephrine and tropicamide eyedrops

Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)

1 Active Comparator

Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops

2 Active Comparator

Premature newborns and neonates treated using insert Mydriasert®

Criteria 

Inclusion Criteria:

Premature newborns, neonates and infants of less 18 months-old indoor in the neonatology clinical department of Robert Debre Hospital with cardiologic monitoring
Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal and/or disk anomalies).
Needing a bilateral fundus
Parents, tutor or legal representing of the patient had been informed of objectives of the study and had given their written consent.
Covered by French social security or CMU

Exclusion Criteria:

Neonates of less 1000g at inclusion
Premature newborn of less 30 weeks of gestational age at inclusion
Contra-indication to one of the evaluated drugs
Any treatment that could provoke a dangerous drug interaction for the patient if associated with one of the drug of the study
Anatomical predisposition to glaucoma, hypertension or any other contra-indication noted by the physician
No Results Posted