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ACTIVE NOT RECRUITING
NCT06577948
NA

The P.A.U.S.E.® Spectacle Study

Sponsor: nthalmic Pty Ltd

View on ClinicalTrials.gov

Summary

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 month 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 month period.

Official title: Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

205

Start Date

2024-09-14

Completion Date

2027-10

Last Updated

2026-03-19

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Single vision spectacle lens

Standard single vision spectacle lens

DEVICE

P.A.U.S.E. spectacle lens 1

P.A.U.S.E. spectacle lens 1

DEVICE

P.A.U.S.E. spectacle lens 2

P.A.U.S.E. spectacle lens 2

Locations (1)

Hai Yen Eye Care

Ho Chi Minh City, Vietnam