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Authors
Iribarren, Rafael
Szeps, Abel
Kotlik, Carlos
de Tomas, Martin
Martin, Gabriel
Rozema, Jos
Lanca, Carla https://orcid.org/0000-0001-9918-787X
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Clinical Trials BETA
Clinical trials referenced in this document:
nct07092072 at ClinicalTrials.govDocuments that mention this clinical trial
One-Year Efficacy and Tolerance of Myofix Defocus Spectacles for Control of Myopia Progression
https://doi.org/10.1007/s40123-025-01270-4
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Funding
Funding for this research was provided by:
Novar
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Article History
Received: 1 September 2025
Accepted: 21 October 2025
First Online: 12 November 2025
Declarations
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: Abel Szeps, Martin de Tomas, Gabriel Martín and Rafael Iribarren are consultants of NOVAR and OPULENS. Jos Rozema is a consultant for Cooper Vision. Carla Lanca reports a relationship with Eyerising that includes consulting and advisory.
: The study protocol was approved by the Ethics Committee of the Argentine Society of Ophthalmology and the Government of Buenos Aires City (March 2023; Registration No. 8638). The study was also registered with the ClinicalTrials.gov Identifier Number: NCT07092072. . Patients who exhibited a myopia progression of − 0.50 D or more within 6 months were excluded from further follow-up. As recommended by the ethics committee, these participants were transitioned to treatment with low-dose atropine. The study was conducted in accordance with the Declaration of Helsinki and its amendments, Good Clinical Practice (GCP) guidelines, and Resolution 1480/11 of the Argentine Ministry of Health. Both parents were verbally informed about the study objectives, and written informed consent was obtained from both parents and children. Participant anonymity was strictly preserved, with all identifying information removed from the dataset prior to statistical analysis.
