The A.R.R.E.S.T.® Spectacle Film Study (NCT06692699) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The A.R.R.E.S.T.® Spectacle Film Study
Vietnam123 participantsStarted 2025-04-12
Plain-language 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.
Who can participate
Age range
6 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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.
* Have best-corrected high contrast visual acuity of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.80) or better in each eye.
* Meet the following criteria determined by cycloplegic autorefraction at Baseline:
* -5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS
* -1.50 DC ≤ astigmatic component ≤ 0 DC
* \|Spherical equivalent anisometropia\| ≤ 1.00 D. Exclusion Criteria
* Participant is currently an active participant in another study or was an active participant in another study within 30 days prior to this study.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Axial Length
Timeframe: 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.