Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT00642135
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:
NCT00642135
Study Brief:
Protocol Section:
NCT00642135