Evaluation of the Efficacy and Safety of the Ophthalmic Insert Mydriasert in Patients Undergoing Retinal Angiography

PURPOSE: To verify the efficacy to obtain mydriasis and cardiovascular safety of Mydriasert (ophthalmic insert containing tropicamide and phenylephrine) in diabetic and nondiabetic patients undergoing retinal angiography by comparing it with usually administered eyedrops (tropicamide 1% and phenylephrine 10%). METHODS: This was a prospective randomized study. A total of 154 eyes of 77 patients were randomly divided into 2 groups: group 1 consisted of 78 eyes, group 2 consisted of 76 eyes, and the patients were monitored for pupillary dilation, blood pressure, heart rate, and possible adverse effects at 0, 20, 40, 60, and 90 minutes. RESULTS: No severe adverse effects were observed in either group. In the entire sample studied, the mean pupillary diameter was greater in the eyedrops group after 20 and 40 minutes, while mydriasis was similar in the 2 groups after 60 minutes. The diabetic patients treated with Mydriasert had less mydriasis than those treated with eyedrops after 20 and 40 minutes, and diabetic patients showed less mydriasis than the nondiabetic patients after 60 and 90 minutes. There was no significant between-group difference in mean heart rate or systolic and diastolic blood pressure at any of the time points. CONCLUSIONS: Mydriasert assures an adequate degree of mydriasis for retinal angiography in both diabetic and nondiabetic patients. There are no differences in efficacy or safety between the insert and the usually administered eyedrops, but the low total drug dose administered with the insert reduces the risk of cardiovascular side effects.