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

NCT07854366 | Not Yet Recruiting

• 1 other identifier: OptiDual26-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High Myopia

Keywords

High Myopia; Orthokeratology; Myopia-Control Spectacle Lenses; Axial Length; Myopia Control

Outcome Measures

Primary Outcomes (1)

• Axial Length，AL

  Measurements were performed using the LENSTAR LS 900 optical biometer, with the change in axial length from baseline to month 12 (ΔAL, mm) serving as the primary outcome measure.

  Month3，Month6，Month12，

Secondary Outcomes (12)

• Equivalent spherical power (SER)

  month6，12

• Measure pupil size

  month6，12

• Corneal higher-order aberrations

  month6，12

• Subretinal choroidal thickness and choroidal blood flow density

  month1，3，6，12

• National Eye Institute 25-Item Visual Function Questionnaire

  month6，12

Study Arms (2)

SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses

EXPERIMENTAL

Device: SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses

M.O.V.E. Lenses Alone

ACTIVE COMPARATOR

Device: M.O.V.E. Lenses Alone

Interventions

SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses DEVICE

Participants wore an OK lens - approved by the NMPA and suitable for their corneal and refractive conditions - during the night, with a target wearing duration of ≥5 nights per week and ≥8 hours per night; full or partial correction was applied based on the approved correction range, corneal topography, and refractive status. During the day, participants wore a standardized 3D dynamic array-designed lens to correct residual refractive error following OK lens wear and to provide a defocusing effect, with a target wearing duration of ≥10 hours per day. Both the OK lens and the 3D dynamic array-designed lens prescriptions were prescribed by trained research ophthalmologists or optometrists in accordance with standardized operating procedures.

SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses

M.O.V.E. Lenses Alone DEVICE

Participants wore frame lenses of the same brand, model, and optical design as the trial group's daytime lenses; the central prescription was fully corrected based on cycloplegic refraction results; the target wearing time was ≥10 hours per day. Visual acuity and refractive status were re-evaluated according to the scheduled schedule; the prescription was adjusted when the criteria for adjustment were met.

M.O.V.E. Lenses Alone

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At least one eye has an equivalent spherical refractive error of -10.00--6.00 D; Binocular astigmatism ≤1.50 D; Anisometropia ≤2.00 D
• Predominantly axial myopia with reliable axial length measurements
• Normal corneal topography (corneal curvature: 39.00-48.00 D), meeting the requirements for fitting orthokeratology lenses for this study
• No administration of low-concentration atropine, repeated low-intensity red light therapy (RLRL), orthokeratology lenses, specially designed spectacles, multifocal/dioptric contact lenses, or any visual function training related to myopia control within the preceding 6 months
• Bimanual intraocular pressure: 10-21 mmHg
• Best-corrected visual acuity ≥20/25
• Corneal endothelial cell density ≥2000 cells/mm² with no other significant endothelial abnormalities
• No ocular diseases that would affect visual acuity or be relevant to this study
• Participants and their guardians must voluntarily participate in the study and sign an informed consent form
• Participants must be able to undergo randomization and wear the prescribed lenses, follow the required care instructions, and attend scheduled follow-up visits.

You may not qualify if:

• Impossibility of safely fitting orthokeratology lenses
• presence of active ocular surface disorders, keratoconus, or other corneal abnormalities; significant abnormalities in tear film or corneal staining
• presence of amblyopia, strabismus, glaucoma, uveitis, cataracts, retinal diseases, or pathological fundus changes due to myopia
• history of ocular surgery or trauma that may have altered corneal morphology or influenced the study evaluation
• presence of systemic diseases that may affect ocular health, lens fitting safety, or treatment compliance
• current use of medications that significantly impact refractive status, axial length, accommodation, or ocular surface condition
• allergy to the study-related lenses, care solutions, or diagnostic agents
• planned use of myopia control measures outside those specified in the study protocol during the study period
• other circumstances deemed unsuitable for participation by the investigator, with the specific reasons documented.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Medical Optometry Center

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09