Étude de la dilatation pupillaire par l’insert ophtalmique Mydriasert ®

Abstract

To evaluate the tolerance and efficiency of the Mydriasert(R) ophthalmic insert on pupil dilation. Two pharmaceutical forms of a combination of tropicamide and phenylephrine (HCl) were compared on both eyes of 80 patients. For each patient, one Mydriasert insert (Ioltech) was placed in the lower conjunctival sac of the eye. Dilation of the control eye was obtained using 0.5% tropicamide eye drops and 10% phenylephrine eye drops (Novartis Ophthalmics), which were instilled with three frequency regimens (5, 10 or 15 min). The pupil diameter was regularly measured until the maximal mydriasis had occurred. Both subjective and objective tolerance of the insert was excellent. The size of the maximal mydriasis obtained when using the insert was significantly greater than that obtained when using the eye drops, regardless of the frequency of the instillation (p < 0.04). The difference in maximal pupil diameter ranged from +0.16 mm to +0.38 mm. Mydriasis kinetics was slower with the insert. The time necessary to obtain a maximal mydriasis was 47.3 min when the insert was used, whereas it was in the range of 31.4 to 38.5 minutes with the eye drops (p < 0.001). As far as pupil diameter is concerned, the superiority of the insert compared to the eye drops became observable only about 45 min after the insert had been placed in the eye. The relative efficacy of the insert compared to the eye drops did not correlate with patient features (p > or = 0.06). Despite the small quantity of drug delivered by the insert, Mydriasert allows a much greater mydriasis compared to that usually obtained when the eye drops were used. However, a longer time lapse is necessary for this to occur.