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 compared to single vision spectacle lenses in myopic children. The main questions it aims to answer are: Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of axial length growth? Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of increase in myopic refractive error? Researchers will compare spectacle lenses using P.A.U.S.E.® technology to a single vision spectacle lens. Participants will: Be randomly allocated to wear either spectacle lenses using P.A.U.S.E.® technology or single vision spectacle lenses. Visit the clinic on five occasions over a 12 month period.
The aim of this clinical trial is to compare the rate of myopia progression as measured by change from the Dispensing visit (up to 26 days from Baseline), in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (tests) and single vision spectacle lenses ( control). Myopic children (6-14 years of age) will be randomly allocated to wear either test 1, test 2, or control. The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months. The visits are Baseline, Dispensing, 1 month, 6 months, and 12 months. All procedures performed at these visits are standard, non invasive clinical tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
250
Standard single vision spectacle lens
P.A.U.S.E. spectacle lens 1
P.A.U.S.E. spectacle lens 2
Hai Yen Eye Care
Ho Chi Minh City, Vietnam
RECRUITINGAxial Length
Difference in change from dispensing in axial length between each test and control.
Time frame: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit
Cycloplegic spherical equivalent autorefraction
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.
Time frame: Baseline, then 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).
Visual performance as measured by high contrast visual acuity at 6 m
Difference in visual acuity between each test and control.
Time frame: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit
Visual performance as measured by a non validated questionnaire based on a 1-10
Difference in subjective visual performance between each test and control.
Time frame: 1 month, 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.