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