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ACTIVE NOT RECRUITING
NCT06692699
NA

The A.R.R.E.S.T.® Spectacle Film Study

Sponsor: nthalmic Pty Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if spectacle films using Active Reconfiguration in Retinal Encoding of Spatio-Temporal (A.R.R.E.S.T.®) signal technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares spectacle films using A.R.R.E.S.T.® technology to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing spectacle films using A.R.R.E.S.T.® technology. The main questions to answer are: Do spectacle films using A.R.R.E.S.T.® technology slow down the rate of axial length growth? Do spectacle films using A.R.R.E.S.T.® technology slow down the rate of increase in myopic refractive error? Researchers will compare spectacle films using A.R.R.E.S.T.® technology to a single vision spectacle lens for 12 months followed by assessing spectacle films using A.R.R.E.S.T.® technology for slowing down myopia progression for another 12 months. Participants will initially be randomly allocated to wear either spectacle films using A.R.R.E.S.T.® technology or single vision spectacle lenses and visit the clinic on seven occasions over a 12 month period. After completing the first 12 months, all participants will wear spectacle films using A.R.R.E.S.T.® technology and visit the clinic on five occasions over the second 12 month period.

Official title: Spectacle Films Utilising A.R.R.E.S.T.® Technology for Slowing Myopia Progression in Vietnamese Children: A Prospective, Controlled, Randomised Clinical Trial

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2025-04-12

Completion Date

2028-07

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DEVICE

Single vision spectacle lens

Standard single vision spectacle lens

DEVICE

A.R.R.E.S.T. spectacle film

A.R.R.E.S.T. spectacle film

Locations (1)

Ha Noi Eye Hospital 2

Hà Nội, Vietnam