Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician-initiated multicenter
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CLINICAL INVESTIGATION
Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician‑initiated multicenter clinical trial Toshio Hisatomi1 · Hiroshi Enaida2 · Shigeo Yoshida3 · Akito Hirakata4 · Masahito Ohji5 · Kohji Nishida6 · Toshiaki Kubota7 · Nahoko Ogata8 · Takaaki Matsui9 · Kazuhiro Kimura10 · Koh‑Hei Sonoda11 · Makiko Uchiyama12 · Junji Kishimoto12 · Koji Todaka12 · Yoichi Nakanishi13,14 · Tatsuro Ishibashi15 Received: 12 January 2020 / Accepted: 16 June 2020 / Published online: 18 August 2020 © Japanese Ophthalmological Society 2020
Abstract Purpose To evaluate the safety and efficacy of BBG (Brilliant Blue G250) for lens capsular staining during cataract surgery with continuous curvilinear capsulorhexis. Study design Prospective clinical study. Methods 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. Results 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. Conclusion 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. Keywords Brilliant Blue G 250 (BBG) · Physician-initiated multicenter clinical trial · Cataract surgery · Continuous curvilinear capsulorhexis Corresponding Author: Tatsuro Ishibashi * Tatsuro Ishibashi [email protected]‑u.ac.jp
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Department of Ophthalmology, Faculty of Medicine, Oita University, Yufu, Japan
Toshio Hisatomi [email protected]‑u.ac.jp
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Department of Ophthalmology, Nara Medical University, Kashihara, Japan
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Ohshima Eye Hospital, Fukuoka, Japan
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Department of Ophthalmology, Chikushi Hospital, Fukuoka University, Chikushino, Japan
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Department of Ophthalmology, Faculty of Medicine, Saga University, Saga, Japan
Department of Ophthalmology, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan
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Department of Ophthalmology, School of Medicine, Kurume University, Kurume, Japan
Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
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Kyorin Eye Cent
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