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The A.R.R.E.S.T.® Spectacle Film Study
Sponsor: nthalmic Pty Ltd
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
Conditions
Interventions
Single vision spectacle lens
Standard single vision spectacle lens
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