Actively Recruiting
The A.R.R.E.S.T.® Spectacle Film Study
Led by nthalmic Pty Ltd · Updated on 2025-04-17
160
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The A.R.R.E.S.T.® Spectacle Film Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 6 to 14 years old inclusive at time of enrolment.
- Have read, understood, and signed the Informed Assent.
- Have their parent or legal guardian read, understood, and signed the Informed Consent.
- Be capable, along with their parent/legal guardian, of understanding the study and willing to follow study requirements.
- Agree with their parent/legal guardian to maintain visit and wearing schedules.
- Agree to wear the study spectacles at least 5 days a week for 6 hours each day during the study.
- Be in good general health as known by the parent/legal guardian.
- Have best-corrected visual acuity of 0.10 logMAR (20/25) or better in each eye.
- Meet specific cycloplegic autorefraction criteria at Baseline including spherical equivalent between -5.00 D and -0.75 D, sphere component ≤ -0.50 DS, astigmatic component between -1.50 DC and 0 DC, and spherical equivalent anisometropia ≤ 1.00 D.
You will not qualify if you...
- Currently participating or participated in another study within 30 days.
- Previous or current use of myopia control treatments such as bifocal/multifocal spectacles or contact lenses, orthokeratology, atropine > 0.01%, or pirenzepine.
- Born earlier than 30 weeks gestation or with birth weight under 1500 g.
- Use of medications affecting eye health or physiology.
- Known allergy to certain eye drops used in the study.
- Presence of strabismus measured by cover test.
- Known ocular or systemic diseases like diabetes, Graves' disease, glaucoma, uveitis, scleritis, or autoimmune diseases.
- Any ocular, systemic, or neuro-developmental conditions affecting refractive development such as cataract, corneal scarring, Marfan's syndrome, Down's syndrome, and others listed.
- Keratoconus or irregular cornea.
- Any other condition deemed by the investigator to prevent fulfilling study requirements or in participant's best interest.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ha Noi Eye Hospital 2
Hà Nội, Vietnam
Actively Recruiting
Research Team
D
Daniel Tilia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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