The P.A.U.S.E.® Spectacle Study

The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are: Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error? Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months. Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 months period. After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 months period.

NCT Number	NCT06577948
Lead Sponsor	nthalmic Pty Ltd Collaborators: Brighten Optix Corporation
Conditions	Myopia, Myopia Progression
Enrollment	205 participants
Start Date	2024-09-14
Primary Completion	2027-10 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-20