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

Childhood high myopia is associated with continued axial elongation and an increased lifetime risk of sight-threatening ocular disease. Overnight orthokeratology temporarily reshapes the cornea and may slow axial elongation; however, children with high myopia may still require daytime spectacles to correct residual refractive error. Whether combining orthokeratology with myopia-control spectacles offers additional benefit over myopia-control spectacles alone remains uncertain.

This single-center, prospective, parallel-group, exploratory superiority randomized controlled trial will enroll 100 children aged 8-14 years with high myopia. Participants will be randomized in a 1:1 ratio using a computer-generated, variable-block sequence stratified by age. Participants, guardians, and lens-fitting personnel will be unmasked; outcome assessors and statistical analysts will remain masked until database lock.

The combined-treatment group will wear SmoothCore orthokeratology lenses for at least 8 hours per night on at least 5 nights per week, together with M.O.V.E. myopia-control spectacles for at least 10 hours per day. Orthokeratology will provide partial correction according to the approved correction range and individual ocular characteristics, while daytime spectacles will correct any residual refractive error. The spectacle-only group will wear the same spectacle lens model and optical design, with full central refractive correction, for at least 10 hours per day. Study lenses will be supplied by the study site and used within their NMPA-approved indications. Prescriptions will be adjusted according to standardized criteria.

Participants will undergo screening and assessments at baseline, 1 day, 1 week, and 1, 3, 6, and 12 months. Adherence will be assessed using lens-wear diaries, questionnaires, and where applicable, contact lens care-solution usage records. Ocular safety assessments will include slit-lamp examination, corneal staining and topography, intraocular pressure measurement, corneal endothelial assessment, and adverse event monitoring. Vision-related quality of life and lens satisfaction will also be evaluated.

The primary outcome is the change in study-eye axial length from baseline to month 12 and change in vision-related quality of life at 3, 6 and 12 months. The study eye will be selected before randomization: the qualifying eye if only one meets the high-myopia criterion, or the right eye if both qualify. Additional outcomes include refractive and corneal changes, adherence, quality of life, satisfaction, and safety. Refractive outcomes will be interpreted as exploratory because orthokeratology alters corneal shape.

The primary analysis will follow the intention-to-treat principle using analysis of covariance adjusted for baseline axial length, age, and baseline spherical equivalent refraction. Sensitivity and supportive analyses will assess the robustness of the findings. Safety will be analyzed according to treatment actually received among participants who receive at least one study intervention.