CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Retinal Anomalies, Premature Birth

Intervention / Treatment
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* Drug: Mydriasert®
* Drug: phenylephrine and tropicamide eyedrops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops | Drug: phenylephrine and tropicamide eyedrops<br>* Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)<br>|
| Active Comparator: 2<br>Premature newborns and neonates treated using insert Mydriasert® | Drug: Mydriasert®<br>* Premature newborns and neonates treated using ophthalmologic insert Mydriasert®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus. |  | 75 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature, neonates, infants, children, Mydriasert®, mydriasis, fundus, Tropicamide, Phenylephrine, clinical trial, Infant, premature newborns, bilateral diagnosis fundus