Status:
TERMINATED
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ioltech
Conditions:
Retinal Anomalies
Premature Birth
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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 (a...
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 evaluat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00642135
Start Date
January 1 2006
End Date
June 1 2008
Last Update
April 10 2008
Active Locations (1)
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1
Hôpital Robert Debré
Paris, France, 75019