High MyopiaNCT07854366
SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
A study testing SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses and M.O.V.E. Lenses Alone in people with High Myopia, run by Beijing Tongren Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- High Myopia
- What is being tested?
- SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses and M.O.V.E. Lenses Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;the power in the most negative principal meridian of the spectacle prescription ≥ -9.00 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.
- Intraocular pressure between 10 and 21 mmHg and best-corrected visual acuity of 20/25 or better in each eye.
- No ocular or systematic disease that could affect vision or study assessments.
- Written informed consent from a legal guardian and assent from the child after an age-appropriate explanation of the study.
- The child and legal guardian are willing to accept random assignment and are able to comply with the prescribed lens wear, lens care, and follow-up requirements.
Who cannot join
- 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.
- A history of ocular surgery or trauma that could affect corneal shape or study assessments.
- Any systemic disease that could affect ocular health, the safety of lens wear, or adherence to study requirements.
- Current use of medications that significantly affect refraction, axial length, accommodation, or the ocular surface.
- Allergy to study-related lenses, lens care solutions, or medications used for study examinations.
About this study
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
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?
Read more
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.
Read the detailed description
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.
- Conditions
- High Myopia
- Being tested
- SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses, M.O.V.E. Lenses Alone
- Keywords
- High Myopia, Orthokeratology, Myopia-Control Spectacle Lenses, Axial Length, Myopia Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmoothCore Technology Orthokeratology Combined with M.O.V.E. LensesDevice
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 AloneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses | Experimental | Not described Receives: Device: SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses |
| M.O.V.E. Lenses Alone | Active comparator | Not described Receives: Device: M.O.V.E. Lenses Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: Baseline and months 3, 6, 12
Secondary outcomes (6)
Vision-related quality of life (Pediatric Refractive Error Profile 2，PREP2)
Scores on the Pediatric Refractive Error Profile 2 (PREP2) range from 0 to 100, with higher scores indicating better vision-related quality of life.
Measured: Baseline and months 1, 3, 6 and 12
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.
Measured: Baseline and months 6, 12
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).
Measured: Baseline and months 3，6, 12
Pupil diameter
Pupil diameter will be measured using the LENSTAR LS 900 optical biometer and reported in millimeters (mm).
Measured: Baseline and months 3，6, 12
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.
Measured: Baseline and months 1, 3, 6,12
Best-corrected visual acuity (BCVA) and presenting visual acuity
The best visual acuity achievable with optimal refractive correction and presenting visual acuity, expressed as the logarithm of the minimum angle of resolution (logMAR). Scores range from -0.3 to 1.0 logMAR, with lower values indicating better visual acuity. A value of 0.0 logMAR corresponds to decimal visual acuity of 1.0.
Measured: Baseline and months 3, 6,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi-Ming Li, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854366
- Sponsor's protocol ID
- OptiDual26-001
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07854366
- Acronym / sponsor ID
- OptiDual26-001
- Conditions
- High Myopia
- Keywords
- High Myopia, Orthokeratology, Myopia-Control Spectacle Lenses, Axial Length, Myopia Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;the power in the most negative principal meridian of the spectacle prescription ≥ -9.00 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.
- Intraocular pressure between 10 and 21 mmHg and best-corrected visual acuity of 20/25 or better in each eye.
Key exclusion criteria (8 listed)
- 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.
- A history of ocular surgery or trauma that could affect corneal shape or study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmoothCore Technology Orthokeratology Combined with M.O.V.E. LensesParticipants 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. | Device | SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses |
| M.O.V.E. Lenses AloneParticipants 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. | Device | M.O.V.E. Lenses Alone |
Primary outcome
Axial elongation
Time frame: Baseline and months 3, 6, 12
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,
6 secondary outcomes
Vision-related quality of life (Pediatric Refractive Error Profile 2，PREP2)
Time frame: Baseline and months 1, 3, 6 and 12
Cycloplegic refraction
Time frame: Baseline and months 6, 12
Corneal higher-order aberrations
Time frame: Baseline and months 3，6, 12
Pupil diameter
Time frame: Baseline and months 3，6, 12
Subfoveal choroidal thickness and choroidal vessel density
Time frame: Baseline and months 1, 3, 6,12
Best-corrected visual acuity (BCVA) and presenting visual acuity
Time frame: Baseline and months 3, 6,12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SmoothCore Technology Orthokeratology Combined with M.O.V.E. Lenses and M.O.V.E. Lenses Alone in people with High Myopia, run by Beijing Tongren Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial elongation (time frame: Baseline and months 3, 6, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.