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

NCT06692699 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Myopia
  • Myopia Progression

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

Sponsors & Collaborators

  • nthalmic Pty Ltd

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-12
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06692699 on ClinicalTrials.gov