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Article History

Received: 15 November 2024

Accepted: 14 April 2025

First Online: 23 May 2025

Declarations

:

: Julian Garcia-Feijoo: Consultant—Alcon, AbbVie, Glaukos, iSTAR, Santen; Thea; Sight Science; Alimera; Elios Vision; Financial support—Alcon, AbbVie, iSTAR, Novartis, Théa, Glaukos, Pfizer, Santen, Elios, ZEISS; Heidelberg; AJL; J&J; B&L; Thea; Sight Science; Rayner; Cutting Edge; Physiol; Biotech and Pfizer. Juan F. Batlle: Consultant—Santen Inc., Aquea Health, W.L. Gore & Associates, Inc.; Paid speaker—Johnson & Johnson Vision; Research support—CORD LLC, InnFocus Inc. (a Santen Pharmaceutical Co Ltd Company), Johnson & Johnson Vision, LensGen Inc., New World Medical Inc., Omega Ophthalmics, Inc., TECLens LLC; Investment interest: Aquea Health, CORD LLC, LensGen Inc. Florent Aptel: Consultant—Allergan, Glaukos, Novartis, Santen, Théa. Yves Lachkar: Consultant for Allergan, Novartis, Santen, Théa. Isabelle Riss: Consultant—Santen; Research support—Santen. Omar Sadruddin: is an employee of Glaukos. Tuan Nguyen: is an employee of Edwards Lifesciences. Henny J.M. Beckers: Consultant—InnFocus Inc. (a Santen Pharmaceutical Co. Ltd. company), Santen, Glaukos, AbbVie, Novartis, Théa, Elios, Nova Eye Medical; Research support—InnFocus Inc. (a Santen Pharmaceutical Co. Ltd. company); Investment interest: Peyeoneer Medtech B.V.

: The individual studies were conducted in line with the principles of the Declaration of Helsinki and the following medical device standards: CFR 21 (INN003 only), MEDDEV 2.12-1 and MEDDEV 2.12/2 revision 2 (INN007 only), MEDDEV 2.7/1 and the European Directive 93/42/EEC (INN004 and INN007 only), and EN ISO 14155 (INN003, INN004, and INN007). Each study site obtained institutional review board approval. Informed consent was gained from all patients prior to enrollment in the individual studies.