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首页> 外文期刊>Ophthalmic surgery, lasers & imaging: the official journal of the International Society for Imaging in the Eye >Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study.
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Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study.

机译：盐酸利多卡因凝胶眼部麻醉:结果的前瞻性随机研究。

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BACKGROUND AND OBJECTIVE: This study evaluates the effectiveness of Akten (Akorn, Inc., Buffalo Grove, IL), a novel ophthalmic gel anesthetic agent for complete ocular anesthesia. PATIENTS AND METHODS: This study was conducted as a prospective, randomized, double-blinded, multicenter Phase III clinical trial to evaluate Akten gel. The study had four cohorts of subjects who received sham gel, Akten 1.5%, Akten 2.5%, and Akten 3.5%, respectively. Subjects were assessed for achievement of anesthesia at defined time intervals and questioned for "pain" or no pain predetermined intervals. RESULTS: A total of 209 subjects were entered into the study. The percentages of patients achieving the primary endpoint (ie, anesthesia within 5 minutes) were as follows: 22% for sham, 88% for Akten 1.5%, 89% for Akten 2.5%, and 92% for Akten 3.5%, respectively. Safety measures including corneal staining, conjunctival hyperemia, and eye pain with administra-tion were low and comparable in all cohorts. CONCLUSION: Akten gelappears to be an effective and safe ocular anesthetic. All doses were well tolerated and no dose-related corneal toxicity was observed.
机译：背景和目的:本研究评估的有效性Akten(阿肯,Inc .的水牛树林,IL),小说眼科凝胶麻醉代理完成眼部麻醉。和方法:本研究是作为一个进行的前瞻性,随机,双盲,多中心三期临床试验评估Akten凝胶。who收到假凝胶,文书1。5%,文书2。5%,分别和Akten 3.5%。评估为实现麻醉的定义时间间隔和质疑“疼痛”疼痛预先确定的时间间隔。将209例患者进入研究。实现的主要比例的患者端点(5分钟)内麻醉Akten骗局,如下:22% 88% 1.5%,89%Akten Akten 2.5%, 92% 3.5%,分别。染色、结膜充血、眼痛酶低和可比性所有的军团。一个有效的和安全的眼部麻醉剂。剂量是耐受性良好,没有剂量相关角膜毒性观察。

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