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SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
Sponsor: Beijing Tongren Hospital
Summary
This clinical trial aims to determine whether a combination of overnight orthokeratology lenses and daytime myopia-control spectacles is more effective than myopia-control spectacles alone in slowing myopia progression and improving vision-related quality of life in children aged 8-14 years with high myopia. Orthokeratology lenses are contact lenses designed to temporarily reshape the anterior surface of the eye during sleep. The study will also asess the safety of this combined treatment.The main questions it seeks to answer are: * Does the combined treatment slow myopia progression over 12 months more effectively than myopia-control spectacles alone? * What ocular problems occur with each treatment, and how well do children adhere to the prescribed lens-wearing schedules? The researchers will compare SmoothCore orthokeratology lenses combined with M.O.V.E. myopia-control spectacle lenses with the same spectacle lenses used alone. A total of 100 children will be randomly assigned to one of the two groups, with an equal chance of being allocated to either group. Participants will: * Wear their assigned spectacle lenses for at least 10 hours per day for 12 months. Children in the combined-treatment group will also wear orthokeratology lenses for at least 8 hours per night on at least 5 nights per week. * Attend clinic visits at baseline and at 1 day, 1 week, and 1, 3, 6, and 12 months for scheduled eye examinations and measurements. * Keep a record of lens-wearing time and any eye discomfort, with assitance from a parent or guardian. * Complete questionnaires about vision-related daily activities and satisfaction with their lenses.
Official title: Effect of SmoothCore Technology Orthokeratology Combined With M.O.V.E. Lenses Versus M.O.V.E. Lenses Alone on Myopia Progression in Children With High Myopia: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
8 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-08
Completion Date
2028-04-01
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses
Participants will wear NMPA-approved orthokeratology (OK) lenses suitable for their corneal characteristics and refractive status overnight, with a target wearing schedule of at least 5 nights per week and at least 8 hours per night. Partial correction will be provided according to the approved correction range, corneal topography, and refractive status. During waking hours, participants will wear the study-specified model of M.O.V.E. spectacle lenses to correct residual refractive error following orthokeratology and provide the intended optical defocus, with a target wearing time of at least 10 hours per day. Prescriptions for both the OK lenses and M.O.V.E. lenses will be determined by trained study ophthalmologists or optometrists in accordance with standardized operating procedures.
M.O.V.E. Lenses Alone
Participants will wear M.O.V.E. spectacle lenses of the same brand, model, and optical design as the daytime lenses used in the experimental group. The central prescription will provide full correction based on cycloplegic refraction, with a target wearing time of at least 10 hours per day. Visual acuity and refractive status will be reassessed at scheduled visits, and the spectacle prescription will be updated when the predefined adjustment criteria are met.