NCT06692699

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: nthalmic Pty Ltd · Network
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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.

Conditions

• Myopia
• Myopia Progression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-12
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-11-18
• Last updated: 2025-04-17

Locations

1 site across 1 country: Vietnam