NCT06577948

The P.A.U.S.E.® Spectacle Study

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: nthalmic Pty Ltd · Network
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aims of this clinical trial are: 1. To compare the rate of myopia progression as measured by change from the Stage 1 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. Myopic children (6-14 years of age) will be randomly allocated to wear either test 1, test 2, or control. 2. To assess the rate of myopia progression as measured by change from the Stage 2 Dispensing visit (up to 26 days from the Stage 1: 12-months visit), in axial length and the change from the Stage 1: 12-months visit in the spherical equivalent cycloplegic autorefraction while wearing P.A.U.S.E.® spectacle lenses. The myopic children from Stage 1 will enter Stage 2. The overall trial duration, including follow-up period, is expected to be approximately 30 months. Each participant's duration is expected to be approximately 24 months. The visits are: Stage 1: Baseline, Dispensing, 1 month, 6 months, and 12 months. Stage 2: Dispensing, 6 months, 12 months All procedures performed at these visits are standard, non invasive clinical tests.

Conditions

• Myopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-14
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-08-29
• Last updated: 2026-03-19

Locations

1 site across 1 country: Vietnam