Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: a Prospective, Masked, Controlled, Randomised, Clinical Trial
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) 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 lenses using P.A.U.S.E.® technology slow down the rate of axial length growth? Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of increase in myopic refractive error? Researchers will compare spectacle lenses using P.A.U.S.E.® technology to a single vision spectacle lens. Participants will: Be randomly allocated to wear either spectacle lenses using P.A.U.S.E.® technology or single vision spectacle lenses. Visit the clinic on five occasions over a 12 month period.
• Be between 6-14 years 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 and able to adhere to study requirements.
• Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
• Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
• Be in good general health, based on the parent's / legal guardian's knowledge.
• Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.8) or better in each eye.
• Meet the following criteria determined by cycloplegic autorefraction at Baseline:
• o-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS. o-1.50 DC ≤ astigmatic component ≤ 0 DC. o\|Spherical equivalent anisometropia\| ≤ 1.00 D.