Journal francais d'ophtalmologie · 2004
[The Mydriasert insert: an alternative to eye drops for preangiographic mydriasis].
Клиническое исследованиеСравнительное исследованиеАннотация на английскомСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Korobelnik J-F, Tavera C, Renaud-Rougier M-B, El Meski S, Colin J
Аннотация
PURPOSE: Mydriasert is an insoluble ophthalmic insert, gradually releasing two well-known active ingredients: phenylephrine and tropicamide. It is indicated in presurgical mydriasis. The purpose was to evaluate its efficacy in obtaining mydriasis required for fluorescein angiography.
MATERIAL AND METHODS: The ability of Mydriasert to provide mydriasis (defined by a pupillary diameter of at least 7 mm) compatible with a bilateral angiographic examination in optimal conditions was evaluated by a comparative, randomised versus active treatment (eye drops) open trial in 72 patients.
RESULTS: All the patients obtained a stable mydriasis allowing angiography. In the Mydriasert group, mydriasis preparation required a mean of 10 min more (Student t test: p<0.001); however, near eyesight recovery was 15 min shorter on average (log-rank test<0.01%) and amounts of active ingredients administered to provide mydriasis were 5-10 times higher in the eye drops reference group. Cardiovascular parameters remained in the normal range in both groups. Three patients of the Mydriasert group presented one ocular symptom of local intolerance, which disappeared in 15 min (exact Fisher test not significant between the treatment groups, p=0.2394). No superficial punctate keratitis was detected during the trial.
CONCLUSION: The treatment by Mydriasert can prepare preangiographic mydriasis as well as the reference treatment. The time required for mydriasis is slightly longer. Near eyesight recovery, faster with Mydriasert, could provide an improvement in patient safety and comfort at the end of the ophthalmologic visit.
MATERIAL AND METHODS: The ability of Mydriasert to provide mydriasis (defined by a pupillary diameter of at least 7 mm) compatible with a bilateral angiographic examination in optimal conditions was evaluated by a comparative, randomised versus active treatment (eye drops) open trial in 72 patients.
RESULTS: All the patients obtained a stable mydriasis allowing angiography. In the Mydriasert group, mydriasis preparation required a mean of 10 min more (Student t test: p<0.001); however, near eyesight recovery was 15 min shorter on average (log-rank test<0.01%) and amounts of active ingredients administered to provide mydriasis were 5-10 times higher in the eye drops reference group. Cardiovascular parameters remained in the normal range in both groups. Three patients of the Mydriasert group presented one ocular symptom of local intolerance, which disappeared in 15 min (exact Fisher test not significant between the treatment groups, p=0.2394). No superficial punctate keratitis was detected during the trial.
CONCLUSION: The treatment by Mydriasert can prepare preangiographic mydriasis as well as the reference treatment. The time required for mydriasis is slightly longer. Near eyesight recovery, faster with Mydriasert, could provide an improvement in patient safety and comfort at the end of the ophthalmologic visit.