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Article History

Received: 31 July 2025

Accepted: 21 October 2025

First Online: 12 November 2025

Declarations

:

: Masaru Inatani, Nobuyuki Shoji, Makoto Aihara, Toshihiro Inoue, Kenji Kashiwagi, Yasuo Kurimoto, Masaki Tanito, Toru Nakazawa, Tadashi Nakano, Makoto Nakamura, Tomomi Higashide, Takeo Fukuchi, Megumi Honjo, Atsuya Miki and Kazuhiko Mori have nothing to disclose. Takeo Hirai, Kotoe Hirouchi and Noriyuki Sasaki are employees of Alcon Japan Ltd.

: Ethics approval was not required to this study because it was conducted as a mandatory step for the approval of EX-PRESS in Japan and complied with the Japanese ministerial ordinance on standards for post-marketing studies, known as Good Post-Marketing Study Practice (GPSP). A GPSP study is conducted to detect or verify information on the incidence of adverse reactions and the quality, efficacy, and safety of a product without specifying the conditions of patients to be included. Under this ordinance, ethical approval of the participating medical institutions and patient consent were not required and were left to the discretion of the participating institutions. In practice, approximately half of the participating institutions obtained approval from their respective institutional review boards (IRBs), while the remaining institutions adopted an opt-out approach. The informed consent for the surgical procedure was obtained from all patients, ensuring appropriate ethical consideration from a clinical perspective. The study protocol was submitted to the PMDA on May 9, 2012, before the study began, and an outline of the study is included in the PMDA's re-examination report.