NCT06577948

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

Active, enrolled NA Last updated 18 May 2026

What this trial tests

NA trial testing Single vision spectacle lens in Myopia in 205 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 September 2024

Primary endpoint
1 October 2027

1 October 2027

Quick facts

Lead sponsor	nthalmic Pty Ltd
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	205
Start date	14 September 2024
Primary completion	1 October 2027
Estimated completion	1 October 2027
Sites	1 location across Vietnam

Drugs / interventions tested

• Single vision spectacle lens
• P.A.U.S.E. spectacle lens 1
• P.A.U.S.E. spectacle lens 2

Conditions studied

• Myopia — all drugs for Myopia →
• Myopia Progression — all drugs for Myopia Progression →

Sponsor

nthalmic Pty Ltd

Who can join

Adults 6 to 14, any sex, with Myopia or Myopia Progression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Axial Length
  Time frame: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Stage 1: Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months), then 6- and 12-months after Stage 2: Dispensing Visit.
  Difference in change from Stage 1 dispensing in axial length between each test and control. The change in axial length from the Stage 2 dispensing.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.