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Article History

Received: 26 November 2025

Revised: 4 March 2026

Accepted: 6 March 2026

First Online: 8 April 2026

Competing interests

: The authors have made the following disclosures: Karla Zadnik reported receiving consultant fees from Vyluma Inc. during the conduct of the study. Ian Flitcroft reported receiving consulting fees from Vyluma Inc., personal fees from CooperVision, EssilorLuxottica, Johnson & Johnson Vision, and Thea and contractual fees for analyses from Ocumetra. Jennifer S. Fogt reported receiving grants from Vyluma Inc., Bausch+Lomb, Eyenovia, Innovega, CooperVision and Interojo; personal fees from Alcon and financial support from Tearoptix outside the submitted work. Louis C. Blumenfeld reported receiving personal fees from Vyluma Inc. during the conduct of the study. Tung M. Fong, Simon P. Chandler, Eric Lang and Houman D. Hemmati reported being employees of Vyluma Inc. during the conduct of the study.

: This study was reviewed and approved by the concerned institutional review board (IRB) in the US or independent ethics committee (IEC) in Europe.

: All participants and/or parents/guardians consented to participate and were free to withdraw at any time. Multiple consent/assent forms were used: informed consent form (ICF) for parents/guardians, informed assent form for children (age ranges of the different assent forms varied by country) and an ICF for subjects 18 years of age.