SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia

Brief Summary

The goal of this clinical trial is to learn whether two treatments can slow high myopia in children. High myopia is severe nearsightedness. Children in this study will be 8 to 14 years old. Researchers will compare special myopia-control glasses used alone with the same glasses plus orthokeratology (ortho-k) lenses. Myopia-control glasses are designed to correct vision and slow eye growth. Ortho-k lenses are special contact lenses worn during sleep. They temporarily reshape the front of the eye. The main questions are: * Does the combined treatment slow eye growth more than the glasses alone over 12 months? * What eye problems or other unwanted effects occur in each group? About 90 participants will be assigned by chance to one of two groups. The combined-treatment group will aim to wear ortho-k lenses for at least 8 hours a night. They will use them on at least 5 nights each week. They will also aim to wear myopia-control glasses during the day. The other group will aim to wear the same type of myopia-control glasses for at least 10 hours each day. Participants will attend screening, baseline, and six follow-up visits over 12 months. They will have eye exams to check eye length, vision, prescription, corneal shape, eye pressure, and eye health. The main measure is the change in eye length after 12 months. A longer eye usually means that myopia has worsened. Participants will also keep a lens-wear diary. They will answer questions about comfort, satisfaction, and how their vision affects daily life.

Related Devices