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

Not Applicable

Recruiting

• Conditions: Myopia; Myopia Progression

• Registration Number: NCT06692699
• Lead Sponsor: nthalmic Pty Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Status Verified: 2025-04
• Study Start: 2025-04-12
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial Length	Dispensing Visit (up to 40 days from Baseline), then 1 month, 3 months, 6 months, 9 months, and 12 months after Dispensing Visit	Difference in change from dispensing in axial length between each test and control.

Secondary Outcome Measures

Name	Time	Method
Cycloplegic spherical equivalent autorefraction	Baseline, then 6 months, and 12 months after Dispensing Visit (up to 40 days from Baseline).	Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.
Visual performance as measured by high contrast visual acuity at 6 m	Dispensing Visit (up to 40 days from Baseline), then 1 month, 3 months, 6 months, 9 months, and 12 months after Dispensing Visit	Difference in visual acuity between each test and control.
Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale	1 month, 3 months, 6 months, 9 months, and 12 months after Dispensing Visit (up to 40 days from Baseline).	Difference in subjective visual performance between test and control.

Trial Locations

Locations (1)

Ha Noi Eye Hospital 2; 🇻🇳 Ha Noi, Vietnam