Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician-initiated multicenter clinical trial.
Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician-initiated multicenter clinical trial.
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亮蓝 g250 (BBG) 用于晶状体囊染色的安全性和有效性：一项由医生发起的多中心临床试验。
DOI：
10.1007/s10384-020-00763-y
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
Ishibashi T.
中科院分区：
文献类型：
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作者：
Hisatomi T;Enaida H;Yoshida S;Hirakata A;Ohji M;Nishida K;Kubota T;Ogata N;Matsui T;Kimura K;Sonoda KH;Uchiyama M;Kishimoto J;Todaka K;Nakanishi Y;Ishibashi T.
评价BBG（亮蓝G250）用于连续环形撕囊白内障手术中透镜囊膜染色的安全性和有效性。前瞻性临床研究。本临床试验入组了30例患者的30只眼，这些患者接受了使用BBG（0.25 mg/mL亮蓝G250）进行囊膜染色的白内障手术。独立数据监测委员会和外科医生对透镜囊的可视化和BBG染色撕囊的难易程度进行了5个等级（0 - 4级）的评价。还根据术后7天的眼部和全身耐受性评价了BBG的安全性。BBG的使用改善了透镜囊的可视化，并在所有患者中进行了完全撕囊。主要终点（独立数据监测委员会评价）显示，使用BBG改善了透镜囊的可视化和撕囊的容易性（2 - 4级）;委员会的分级结果与外科医生的分级结果相似。双眼以上常见的并发症为结膜充血、角膜水肿和眼压升高。在眼部和全身评价中未观察到严重并发症。BBG染色有助于改善透镜囊的可视化，并有助于在白内障手术期间完成撕囊术。使用BBG进行荚膜染色也显示出有利的安全性结果。
To evaluate the safety and efficacy of BBG (Brilliant Blue G250) for lens capsular staining during cataract surgery with continuous curvilinear capsulorhexis. Prospective clinical study. This clinical trial enrolled 30 eyes of 30 patients who underwent cataract surgery with BBG (0.25 mg/mL Brilliant Blue G250) for capsular staining. Visualization of the lens capsule and the ease of capsulorhexis with BBG staining were evaluated in five grades (grade 0 to 4) by the Independent Data Monitoring Committee and the surgeons. The safety of BBG was also evaluated in terms of ocular and systemic tolerance for 7 days after surgery. The use of BBG improved visualization of the lens capsule and complete capsulorhexis was performed in all patients. The major endpoint (Independent Data Monitoring Committee evaluation) showed that use of BBG improved visualization of the lens capsule and the ease of capsulorhexis (grades 2 to 4); the committee's grading results were similar to those of the surgeons. Frequent complications observed in more than two eyes were conjunctival injection, corneal edema and intraocular pressure elevation. No severe complications were observed in ocular and systemic evaluations. BBG staining contributed to improved visualization of the lens capsule and aided in the completion of capsulorhexis during cataract surgery. The use of BBG for capsular staining also exhibited favorable safety results.