Ophthalmic insert for pupillary mydriasis in neonates.

Purpose To study efficacy and tolerance of ophthalmic insert Mydriasert® versus standard treatment phenylephrine and tropicamide eye drops for fundus examination in neonates. Methods Prospective, randomised, single-blinded non-inferiority study of 80 premature and full-term babies and infants treated for fundus examination. Mydriasis was obtained with two groups randomly assigned. The eye drop group received three instillations of 2.5% phenylephrine and 0.5% tropicamide and the insert group received Mydriasert® containing phenylephrine and tropicamide. The mydriasis was evaluated 75 minutes after the introduction of the mydriatic agents. Results The mydriasis was successfully achieved in both eyes in 97.5% of infants in the insert group and 90% in the eye drop group at 75 minutes after dispensation. The efficacy of the insert was non-inferior compared to the eye drops. To reach effective mydriasis, the insert group required fewer nursing interventions for one patient comparing to the eye drop group. Good general and local tolerance was observed in the two groups. However two patients reported an adverse event as bradycardia and gastro-oesophageal reflux that could be related to neonate pathology. Conclusions Mydriasis obtained with the ophthalmic insert Mydriasert® was not inferior compared to standard eye drop treatment. Insert reduced the number of nursing interventions to obtain mydriasis for a fundus examination. [ABSTRACT FROM AUTHOR]