Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.
There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.
• 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.
• Possess wearable and visually functioning spectacles.
• 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 (20/25, 6/7.6) 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.