Clinical trial NCT00642135: CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Retinal Anomalies
Premature Birth
Keywords: premature
neonates
infants
children
Mydriasert®
mydriasis
fundus
Tropicamide
Phenylephrine
clinical trial
Infant
premature newborns
bilateral diagnosis fundus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ioltech
First posted: 2008-03-24
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
timeFrame: 75 minutes
Secondary outcomes:
measure: Frequency of the nurse intervention to obtain the mydriasis
timeFrame: during 215 minutes maximum
measure: Calculation of the dose of active drugs administrated
timeFrame: one day
measure: Local and systemic clinical tolerance
timeFrame: one day
measure: Occurrence of adverse reactions
timeFrame: one day
measure: Stability of a mydriasis of good quality at T+195
timeFrame: at T+195 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré
Study officials:
affiliation: Hôpital Robert Debré, APHP, France
name: Dominique BREMOND GIGNAC, MD
role: PRINCIPAL_INVESTIGATOR
References: