Comparison of mydriatic effects between 4 regimens of a tropicamidephenylephrine combination in diabetic patients: a randomized clinical trial
Keywords:
Anesthetics, Diabetic retinopathy, Dilatation, Pupil, Topical administrationAbstract
Introduction: Pupillary dilation is essential for eye
examination and surgery, but longstanding diabetes affects autonomic nervous responses. Pupillary dilation in diabetic patients may require repeated mydriatic drops to achieve adequate pupillary size.
Objective: To determine the most efficient method of a 0.8% tropicamide – 5% phenylephrine combination administration for pupillary dilation in diabetic patients.
Methods: This prospective randomized controlled study compared the efficacy and safety of four mydriatic regimens applied to 84 diabetic patients (168 eyes) scheduled for retinopathy screening. Both eyes of each patient received either one or three mydriatic drops, with one eye randomly assigned to receive antecedent 0.5% tetracaine. Pupillary size, blood pressure, and pulse rate were measured at baseline, and 10-, 20-, and 30-minutes post-administration.
Results: Repeated measures analysis of variance revealed no significant difference in pupillary dilation between each administration group of 42 eyes (p=0.901). Significant interactions were observed for time × sex (p<0.001) and time × age (p<0.001). Women exhibited faster initial dilation at minute 10, while patients over 70 years achieved smaller final diameters. Over 80% of eyes in each group reached the clinical success threshold (≥6 mm) by 30 minutes. Measurement at minute 20 was a highly accurate predictor of final success (area under the receiver operating characteristic curve=0.935). Systemically, blood pressure
remained stable (p≥0.140) in all groups, but a pulse rate reduction (5.1 beats/min) only occurred in non-hypertensive cohort (p=0.004).
Conclusions: A single-drop regimen is equally effective and safe for diabetic patients. Implementing a 5-mm check at minute 20 can efficiently identify slow dilators requiring additional intervention, thereby optimizing outpatient workflow.
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