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.
Children aged 8 to 14 years, regardless of sex.
Cycloplegic spherical equivalent refraction between -9.00 D and -5.00 D in at least one eye; astigmatism ≤1.50 D in each eye; and anisometropia ≤ 2.00 D.
Normal corneal topography and corneal curvature between 39.00 and 48.00 D, meeting the fitting requirements for the study's orthokeratology lenses. Corneal endothelial cell density of at least 2,000 cells/mm², with no other significant corneal endothelial abnormalities.
No use of low-concentration atropine, repeated low-level red-light therapy, orthokeratology lenses, spectacle lenses with special optical designs for myopia control or vision training for myopia control within the 3 months before screening.
Inability to be safely fitted with orthokeratology lenses.
Active ocular surface disease, keratoconus, or other corneal abnormalities.
Clinically significant tear film abnormalities or corneal staining.
Amblyopia, strabismus, glaucoma, uveitis, cataract, retinal disease, or fundus changes associated with pathologic myopia.
Parallel
SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses
DeviceParticipants 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
DeviceParticipants 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.
Axial elongation
Change in axial length from baseline to month 12 (ΔAL, mm) serves as the primary outcome measure. Axial length will be measured in millimeters using the LENSTAR LS 900 optical biometer,
Vision-related quality of life and satisfaction (National Eye Institute 25-Item Visual Function Questionnaire，NEI VFQ-25)
The score of NEI VFQ-25 (National Eye Institute 25-Item Visual Function Questionnaire) ranges from 0 to 100, with higher scores indicating better vision-related quality of life.
Cycloplegic refraction
Cycloplegic refraction will be measured using an autorefractor after cycloplegia and calculated as spherical power plus one-half of cylindrical power, in diopters (D). Change will be calculated as the follow-up value minus the baseline value.
Corneal higher-order aberrations
Anterior corneal higher-order aberrations will be measured using the Pentacam system. The root mean square (RMS) of Zernike terms of orders 3 through 6 will be calculated over a standardized 6.0 mm analysis diameter and reported in micrometers (µm).
Pupil diameter
Pupil diameter will be measured using the LENSTAR LS 900 optical biometer and reported in millimeters (mm).
Subfoveal choroidal thickness and choroidal vessel density
Subfoveal choroidal thickness will be measured using optical coherence tomography and reported in micrometers (µm). Flow density will be defined as the percentage of the analyzable region occupied by detected flow signal in the choriocapillaris slab. Assessments will be performed between 8:00 and 10:00 a.m. to reduce variation associated with time of day.
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