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document
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 .
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Intervention_Physical
ophthalmic insert Mydriasert
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Intervention_Pharmacological
( tropicamide 1 % and phenylephrine 10 % )
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Intervention_Pharmacological
Mydriasert
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Intervention_Pharmacological
Mydriasert
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Outcome_Adverse-effects
severe adverse effects
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Outcome_Physical
mean pupillary diameter
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Outcome_Physical
mydriasis
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Outcome_Physical
mydriasis
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Outcome_Physical
mean heart rate
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Outcome_Physical
systolic
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Outcome_Physical
diastolic blood pressure
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Participant_Condition
retinal angiography
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Participant_Condition
diabetic and nondiabetic
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Participant_Sample-size
77
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Participant_Condition
diabetic patients
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Participant_Condition
diabetic and nondiabetic