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L. Levet, O. Touzeau, S.E. Scheer, V.M. Borderie, L. Laroche; Comparative Study of Pupil Dilation: Ophthalmic Insert versus Eye Drops . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4454.
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Purpose: To compare pupil dilation obtained by an ophthalmic insert versus conventional mydriatic eye drops. Methods: Two pharmaceutical forms of a combination of tropicamide and phenylephrine (HCl) were compared on 80 eyes (40 patients). For each patient, one Mydriasert® ophthalmic insert - holding phenylephrine and tropicamide - was placed in the lower conjunctival sac of the eye. Dilation of the control-eye was obtained using Phenylephrine 10% eye drops and Tropicamide 0.50% eye drops, which were instilled every 10 minutes. The pupil diameter was regularly measured, until achievement of the maximal mydriasis. Results: The size of the maximal mydriasis obtained by the insert is significantly superior to that obtained when using eye-drops (pupil diameter 7.94 mm vs 7.45 mn p<0.001). The time necessary to obtain maximal mydriasis is significantly greater when using the insert (47.3 mn versus 31.8 mn p<0.001). The relative efficacy of the insert compared to eye-drops is not correlated to patient parameters including age, sex, iris color, ethnic group, and mellitus diabetes (p>0.06). Conclusions: Despite the small amount of product freed, Mydriasert® permits the achievement of a mydriasis superior to that usually obtained with normal eye-drops. There is however a more important time-lapse.
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