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

Phase 3

Terminated

• Conditions: Retinal Anomalies; Premature Birth
• Interventions: Drug: phenylephrine and tropicamide eyedrops; Drug: Mydriasert®

• Registration Number: NCT00642135
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Primary Completion: 2008-02
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Last Update Submitted: 2008-04-09
• Last Update Posted: 2008-04-10
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	phenylephrine and tropicamide eyedrops	Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
2	Mydriasert®	Premature newborns and neonates treated using insert Mydriasert®

Primary Outcome Measures

Name	Time	Method
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.	75 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Robert Debré; 🇫🇷 Paris, France