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

NCT06692699 | Active Not Recruiting

• 1 other identifier: nthal2024-02
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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 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

Keywords

axial length; cycloplegic spherical equivalent autorefraction

Outcome Measures

Primary Outcomes (1)

• Axial Length

  Difference in change from Stage 1 dispensing in axial length between test and control. The change in axial length from the Stage 2 dispensing.

  Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 3-, 6-, 9-, and 12- months after Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12-months:), then 3-, 6-, 9-, and 12- months after Dispensing Visit.

Secondary Outcomes (3)

• Cycloplegic spherical equivalent autorefraction

  Stage 1: Baseline, then 6- and 12- months after Dispensing Visit (up to 40 days from Baseline). Stage 2: Stage 1: 12-months visit, then 6- and 12-months after Stage 2 Dispensing Visit (up to 40 days from Stage 1: 12 months visit).

• Visual performance as measured by high contrast visual acuity at 6 m

  Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 3-, 6-, 9-, and 12-months after Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12-months visit), then 3-, 6-, 9-, and 12-months after Dispensing Visit.

• Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale

  Stage 1: 1-, 3-, 6-, 9-, and 12-months after Dispensing Visit (up to 40 days from Baseline). Stage 2: 3-, 6-, 9-, and 12-months after Dispensing Visit (up to 40 days from Stage 2: 12-months Visit).

Study Arms (2)

Assigned Intervention 1

ACTIVE COMPARATOR

Single vision spectacle lens

Device: Single vision spectacle lens

Assigned Intervention 2

EXPERIMENTAL

A.R.R.E.S.T.® spectacle films

Device: A.R.R.E.S.T. spectacle film

Interventions

Single vision spectacle lens DEVICE

Standard single vision spectacle lens

Assigned Intervention 1

A.R.R.E.S.T. spectacle film DEVICE

A.R.R.E.S.T. spectacle film

Assigned Intervention 2

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be between 6 to 14 years old inclusive at time of enrolment.
• Have:
• Read the Informed Assent.
• Been explained the Informed Assent.
• Indicated an understanding of the Informed Assent.
• Signed the Informed Assent.
• Have their parent / legal guardian.
• Read the Informed Consent.
• Been explained the Informed Consent.
• Indicated an understanding of the Informed Consent.
• Signed the Informed Consent.
• Along with their parent/legal guardian, be capable of comprehending the nature of the study and be willing to adhere to the study requirements.
• Along with their parent/legal guardian, agree to maintain the visit and prescribed wearing schedule.
• Agree to wear the study spectacles for a minimum of 5 days/week, 6 hours/day for the duration of the study and to inform the investigator if their schedule is interrupted.
• Be in good general health, based on parent's/legal guardian's knowledge.

You may not qualify if:

• Participant is currently an active participant in another study or was an active participant in another study within 30 days prior to this study.
• Current or prior use of interventions intended for myopia control, including but not limited to:
• Optical devices:
• Bifocal / multifocal spectacles.
• Bifocal / multifocal contact lenses.
• Orthokeratology.
• Pharmacological agents:
• Atropine with a concentration \> 0.01%.
• Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
• Pirenzepine.
• Participant born earlier than 30 weeks or weighed \< 1500 g at birth.
• A verbal report from the participant's parent / legal guardian is sufficient.
• Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
• A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
• Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.

Sponsors & Collaborators

• nthalmic Pty Ltd: lead

Study Sites (1)

Ha Noi Eye Hospital 2

Hà Nội, Vietnam

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: April 12, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)