Extended Depth Of Focus (EDOF) contact lenses for myopia management in children

The intervention in this study involves the use of Extended Depth of Focus (EDOF) contact lenses as an optical approach for myopia control in children. Participants will be fitted with soft EDOF contact lenses prescribed according to their individual refractive error to provide full distance vision correction while delivering a controlled peripheral defocus intended to slow myopia progression. The contact lenses will be fitted and reviewed by a qualified and registered optometrist with experience in paediatric contact lens practice, in accordance with standard clinical fitting guidelines. This will be randomised, single-masked, controlled study. Two hundred and forty myopic children (240) will be divided into two groups. Group 1 (Low Myopia) consist of participants with refractive error range from -0.50DS to -4.75DS whereby Group 2 (High Myopia) consist of participants with refractive error range from -5.00DS to -8.00DS. In other words, the subjects are not randomised, but rather allocated based on their refractive error. Randomisation will occur when assigning the type of lens to be worn within each group. In both Group 1 and Group 2, each participant will be randomly assigned using an online randomiser to wear either Middle EDOF, High EDOF or Single Vision lens. Both EDOF types of lens will serve as experimental group while Single Vision lens will act as a control group. In summary, there will be six sub-groups listed below: • Group 1A – Low Myopia + Middle EDOF • Group 1B – Low Myopia + High EDOF • Group 1C – Low Myopia + Single Vision (control) • Group 2A – High Myopia + Middle EDOF • Group 2B – High Myopia + High EDOF • Group 2C – High Myopia + Single Vision (control) Participants and their parents or guardians will receive verbal and written instructions on correct contact lens insertion and removal, hygiene practices, daily wear schedule, and safe lens handling through handouts on their first visit. Participants will be instructed to wear the daily disposable EDOF contact lenses eight hours per day, at least five days a week. The intervention will be delivered through individual, face-to-face clinical visits conducted in an optometry clinic or university eye clinic setting and will continue over a follow-up period of 24 months, with scheduled review visits every six-month intervals (6, 12, 18 and 24 months) to investigate the changes of axial length elongation, spherical equivalent refraction, ocular dimension, binocular vision status, peripheral refraction, retinal and choroidal thickness. Virtual follow-ups will be conducted monthly to ensure participants' vision and comfort. Participants will undergo cycloplegic auto-refraction to ensure accurate assessment of refractive error. Cycloplegia will be induced using 1% cyclopentolate hydrochloride (Cyclogyl), which will be administered by trained clinical personnel according to standard clinical protocols. Cycloplegic refraction will be performed every six months over the 24-month study period. The study will be conducted under the supervision of a consultant ophthalmologist from Hospital Al-Sultan Abdullah (HASA), UiTM, who will be available for consultation and management in the event of any ocular complications or clinical emergencies arising during the study period. Appropriate referral pathways will be in place to ensure timely ophthalmological assessment and care when required.