Document is current

Article History

Received: 29 January 2025

Accepted: 4 March 2025

First Online: 25 March 2025

Declarations

:

: Iqbal Ike K. Ahmed has received consulting fees from Aequus, Ace Vision, Aerie Pharmaceuticals, Akorn, Alcon, Allergan, Aquea Health, Inc, ArcScan, Avellino Lab USA, Inc, Avisi, Bausch Health, Beaver Visitec, Beyeonics, Bionode, Carl Zeiss Meditec, Centricity Vision, Inc, CorNeat Vision, Custom Surgical, Elios Vision, ElutiMed, Equinox, eyeFlow, Inc, EyeMed, Exhaura Limited, Genentech, Glaukos, Gore, Heine, Heru, Iantrek, InjectSense, Iridex, iStar, Ivantis, Johnson & Johnson Vision, Labtician Thea, LayerBio, Leica Microsystems, LifeLong Vision, Long Bridge Medical, Inc, MicroOptx, MST Surgical, Myra Vision, New World Medical, NovaEye, Ocular Instruments, Ocular Therapeutix, Oculo, Oculus Surgical, Omega Ophthalmics, PolyActiva, PulseMedica, Radiance Therapeutics, Inc, Rheon Medical SA, Ripple Therapeutics, Sanoculis, Santen, Shifamed, LLC, Sight Sciences, Smartlens, Inc, Stroma, Thea Pharma, ViaLase, Visus Therapeutics, Vizzario, VSY Biotechnology, and Zilia, Inc; research grants/support from Aerie Pharmaceuticals, Alcon, Allergan, Bionode, Glaukos, iCare, Ivantis, Johnson & Johnson Vision, New World Medical, and Santen; and speaker honoraria from Alcon, Allergan, Carl Zeiss Meditec, Heine, Johnson & Johnson Vision, MST Surgical, and Singapore Biodesign Programme Office. John P. Berdahl has received consulting fees from Alcon, Bausch + Lomb, Elios Vision, Inc., Glaukos, Imprimis, Sight Sciences, ViaLase, Johnson & Johnson; lecture/honoraria support from Alcon, Bausch + Lomb, Glaukos, Imprimis, ViaLase; and research/grant support from Alcon, and Glaukos. Arkadiy Yadgarov has received consulting fees from AbbVie, Alcon, Bausch + Lomb, Glaukos, IanTrek, and Sight Sciences. George R. Reiss has received consulting fees from Alcon, Allergan/Abbvie, Elios, Glaukos, iStar Medical, New World Medical, Sanoculis, Spyglass, Radius XR and WL Gore & Associates. Steven R. Sarkisian Jr. has received financial support from Glaukos, AbbVie, Allysta Pharmaceuticals, Elios Vision, iStar Medical, Ocular Therapeutix, Sight Sciences, Inc., Bausch + Lomb, Carl Zeiss Meditec USA, Inc., Aerie Pharmaceuticals, Inc., TearLab Corp.; consulting fees from Glaukos, Alcon Laboratories, Inc., AbbVie, Bausch + Lomb, Beaver-Visitec International, Inc., Icare USA, Inc., Ocular Science, Sight Sciences, Inc.; lecture fees from Aerie Pharmaceuticals, Inc., Alcon Laboratories, Inc., AbbVie, Bausch + Lomb. Sébastien Gagné has received consulting fees from Alcon, Allergan/Abbvie, Glaukos, and Johnson and Johnson; research/grant support from Alcon, Allergan/Abbvie, Bayer, Clearside Biomedical, Glaukos, iStar, Johnson and Johnson, LightX Innovations, MicroOptx, Novartis, Roche, Sandoz, and Zilia; and owns stock/stock options in LightX innovations. Marco Robles has received research/grant support from Glaukos. Lilit A. Voskanyan has received research/grant support from Glaukos. Omar Sadruddin, Dari Parizadeh, Angela C. Kothe, Jane Ellen Giamporcaro, L. Jay Katz, and Tomas Navratil are employees of Glaukos Corporation and may have received stock and/or stock options.

: Human subjects were included in this trial. The trial was undertaken in accordance with the tenets of the Declaration of Helsinki, and the protocol, consensus ethical principles derived from international guidelines and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable ICH Good Clinical Practice (GCP) Guidelines, and applicable laws and regulations. Prior to study initiation, the protocol, informed consent and other relevant documentation were reviewed and approved by institutional review boards (IRB)/ethics committees (EC) (Advarra, Aurora, ON, Canada [approval dates 22 October 2021 and 5 November 2021] for two sites in Quebec, Canada and the single site in Ontario, Canada; CHUM (Centre hospitalier de l’Université de Montréal), Montreal, QC, Canada [approval date 21 June 2022] for the third site in Quebec, Canada; Health and Disability Ethics Committees, Wellington, New Zealand [approval date 10 March 2022] for the single site in New Zealand; Zugume Comite De Etica Independiente, Guatemala, Guatemala [approval date 20 October 2021] for the single site in Honduras; and the Armenian Ministry of Health, Yerevan, Armenia [approval date 26 September 2022] for the single site in Armenia). Prospective informed consent was obtained of all participants. The trial was registered with the National Library of Medicine (ClinicalTrials.gov, NCT05127551).