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The P.A.U.S.E.® Spectacle Study

NCT06577948 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2026-05-20

No results posted yet for this study

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 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.

Conditions

  • Myopia
  • Myopia Progression

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

Sponsors & Collaborators

  • Brighten Optix Corporation

    collaborator UNKNOWN

  • nthalmic Pty Ltd

    lead NETWORK

Principal Investigators

  • Daniel Tilia, MOptom, PhD · nthalmic Pty Lyd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-14
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577948 on ClinicalTrials.gov