SmoothCore Orthokeratology Plus M.O.V.E. Lenses vs. M.O.V.E. Lenses Alone for Myopia Control in Children With High Myopia
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?
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Axial elongation
Zeitfenster: 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, |
Baseline and months 3, 6, 12
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Vision-related quality of life (Pediatric Refractive Error Profile 2，PREP2)
Zeitfenster: Baseline and months 1, 3, 6 and 12
|
Scores on the Pediatric Refractive Error Profile 2 (PREP2) range from 0 to 100, with higher scores indicating better vision-related quality of life. |
Baseline and months 1, 3, 6 and 12
|
|
Cycloplegic refraction
Zeitfenster: Baseline and months 6, 12
|
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. |
Baseline and months 6, 12
|
|
Corneal higher-order aberrations
Zeitfenster: Baseline and months 3，6, 12
|
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). |
Baseline and months 3，6, 12
|
|
Pupil diameter
Zeitfenster: Baseline and months 3，6, 12
|
Pupil diameter will be measured using the LENSTAR LS 900 optical biometer and reported in millimeters (mm). |
Baseline and months 3，6, 12
|
|
Subfoveal choroidal thickness and choroidal vessel density
Zeitfenster: Baseline and months 1, 3, 6,12
|
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. |
Baseline and months 1, 3, 6,12
|
|
Best-corrected visual acuity (BCVA) and presenting visual acuity
Zeitfenster: Baseline and months 3, 6,12
|
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. |
Baseline and months 3, 6,12
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- OptiDual26-001
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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