Premature Birth, Retinal Anomalies
Conditions
Keywords
premature, neonates, infants, children, Mydriasert®, mydriasis, fundus, Tropicamide, Phenylephrine, clinical trial, Infant, premature newborns, bilateral diagnosis fundus
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.
Interventions
DRUGMydriasert®
Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
DRUGphenylephrine and tropicamide eyedrops
Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
Sponsors
Ioltech
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus. | 75 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of the nurse intervention to obtain the mydriasis | during 215 minutes maximum |
| Calculation of the dose of active drugs administrated | one day |
| Local and systemic clinical tolerance | one day |
| Occurrence of adverse reactions | one day |
| Stability of a mydriasis of good quality at T+195 | at T+195 minutes |
Countries
France
Outcome results
None listed