OBJECTIVE: To compare the clinical efficacy and systemic side effects of2.5% and 10%phenylephrinefor mydriasis in diabetic patient with darkly pigmented irides. MATERIAL AND METHOD: A prospective randomized double-blind controlled trial was conducted. One hundred diabetic patients were randomly allocated into 2.5% and 10% phenylephrine groups by block randomization. Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations. RESULTS: The mean pupil diameters after instillation in the right eye were 7.05 +/- 0.71 mm (2.5% phenylephrine group) and 7.40 +/- 0.72 mm (10% phenylephrine group, p = 0.02) and in the left eye were 7.05 +/- 0.72 mm (2.5% phenylephrine group) and 7.39 +/- 0.72 mm (10% phenylephrine group, p = 0.02). There was no clinically significant difference in mean heart rate, mean systolic and diastolic blood pressure. CONCLUSION: In diabetic patients with darkly pigmented irides, 10% phenylephrine is more effective than 2.5% phenylephrine with statistical significance. The authors recommend a single dose of 10% phenyleprine for mydriasis in these patients. However the lower concentration is recommended for use in those who exhibit a higher prevalence ofsignificant vascular disease and autonomic dysfunction and seem to be susceptible to severe adverse reaction of phenylephrine.
RCT Entities:
OBJECTIVE: To compare the clinical efficacy and systemic side effects of2.5% and 10%phenylephrinefor mydriasis in diabeticpatient with darkly pigmented irides. MATERIAL AND METHOD: A prospective randomized double-blind controlled trial was conducted. One hundred diabeticpatients were randomly allocated into 2.5% and 10% phenylephrine groups by block randomization. Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations. RESULTS: The mean pupil diameters after instillation in the right eye were 7.05 +/- 0.71 mm (2.5% phenylephrine group) and 7.40 +/- 0.72 mm (10% phenylephrine group, p = 0.02) and in the left eye were 7.05 +/- 0.72 mm (2.5% phenylephrine group) and 7.39 +/- 0.72 mm (10% phenylephrine group, p = 0.02). There was no clinically significant difference in mean heart rate, mean systolic and diastolic blood pressure. CONCLUSION: In diabeticpatients with darkly pigmented irides, 10% phenylephrine is more effective than 2.5% phenylephrine with statistical significance. The authors recommend a single dose of 10% phenyleprine for mydriasis in these patients. However the lower concentration is recommended for use in those who exhibit a higher prevalence ofsignificant vascular disease and autonomic dysfunction and seem to be susceptible to severe adverse reaction of phenylephrine.