A Phase 3 interventional study of Mydriasert® and phenylephrine and tropicamide eyedrops in Retinal Anomalies and Premature Birth, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged Up to 18 Months. Per ClinicalTrials.gov, last updated 2008-04-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 80 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
Drug: phenylephrine and tropicamide eyedrops
Premature newborns and neonates treated using insert Mydriasert®
Drug: Mydriasert®
Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Time frame: 75 minutes
Frequency of the nurse intervention to obtain the mydriasis
Time frame: during 215 minutes maximum
Calculation of the dose of active drugs administrated
Time frame: one day
Local and systemic clinical tolerance
Time frame: one day
Occurrence of adverse reactions
Time frame: one day
Stability of a mydriasis of good quality at T+195
Time frame: at T+195 minutes
This study is terminated, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris