RecruitingNot ApplicableNCT06692699

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

Spectacle Films Utilising A.R.R.E.S.T.® Technology for Slowing Myopia Progression in Vietnamese Children: A Prospective, Controlled, Randomised Clinical Trial

Sponsor

nthalmic Pty Ltd

Enrollment

160 participants

Start Date

Apr 12, 2025

Study Type

INTERVENTIONAL

Conditions

Myopia Myopia Progression

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.

Eligibility

Min Age: 6 YearsMax Age: 14 Years

Inclusion Criteria19

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:
D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS
DC ≤ astigmatic component ≤ 0 DC

Exclusion Criteria35

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.
Known ocular or systemic disease, such as but not limited to:
Diabetes.
Graves' disease.
Glaucoma.
Uveitis.
Scleritis.
Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
Persistent pupillary membrane.
Vitreous haemorrhage.
Cataract.
Central corneal scarring.
Eyelid haemangiomas.
Marfan's syndrome.
Down's syndrome.
Ehler's-Danlos syndrome.
Stickler's syndrome.
Ocular albinism.
Retinopathy of prematurity.
Keratoconus or irregular cornea. The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.