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Spectacle Films Utilising A.R.R.E.S.T.® Technology for Slowing Myopia Progression in Vietnamese Children: A Prospective, Controlled, Randomised Clinical Trial
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 compared to single vision spectacle lenses in myopic children. The main questions it aims 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. Participants will: Be randomly allocated to wear either spectacle lenses using A.R.R.E.S.T.® technology or single vision spectacle lenses. Visit the clinic on seven occasions over a 12 month period.
The aim of this clinical trial is to compare the rate of myopia progression as measured by change from the Dispensing visit (up to 40 days from Baseline), in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between a spectacle film design using A.R.R.E.S.T.® technology (test) and a single vision spectacle lens (control). Myopic children (6-14 years of age) will be randomly allocated to wear either test or control. The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months. The visits are Baseline, Dispensing, 1 month, 3 months, 6 months, 9 months, and 12 months. All procedures performed at these visits are standard, non invasive clinical tests.
Age
6 - 14 years
Sex
ALL
Healthy Volunteers
No
Ha Noi Eye Hospital 2
Hà Nội, Vietnam
Start Date
April 12, 2025
Primary Completion Date
July 1, 2026
Completion Date
July 1, 2026
Last Updated
April 17, 2025
160
ESTIMATED participants
Single vision spectacle lens
DEVICE
A.R.R.E.S.T. spectacle film
DEVICE
Lead Sponsor
nthalmic Pty Ltd
NCT07078799
NCT07329777
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07323251