Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:08 AM
Study NCT ID:
NCT07387159
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Axial Length', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in axial length, measured in millimeters (mm)'}, {'measure': 'Change in Spherical Equivalent Refraction', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in cycloplegic spherical equivalent refraction, measured in diopters (D)'}], 'secondaryOutcomes': [{'measure': 'Peripheral Refraction', 'timeFrame': 'At first prescription (Visit 2, within 3±1 weeks after baseline)', 'description': 'Peripheral refraction values at various retinal points (e.g., 20° and 30° nasally, temporally, superiorly, inferiorly), measured in diopters (D) with an open-field autorefractometer, without correction and with new MiYOSMART iQ spectacles'}, {'measure': 'Contrast Sensitivity', 'timeFrame': 'At first prescription (Visit 2, within 3±1 weeks after baseline)', 'description': 'Spatial contrast sensitivity (log units) for various spatial frequencies, measured with the "Mesotest" device in a trial frame and with new MiYOSMART iQ spectacles'}, {'measure': 'Safety - Incidence of Adverse Events', 'timeFrame': 'Throughout the study period, up to 6 months', 'description': 'Frequency, nature, and severity of all recorded Adverse Events (AEs) and Device Deficiencies (DDs) related to the use of MiYOSMART iQ spectacles.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia control, spectacle lenses, peripheral defocus, DIMS, MiYOSMART'], 'conditions': ['Myopia, Child Myopia Progression']}, 'descriptionModule': {'briefSummary': 'This prospective, single-center study aims to evaluate the efficacy and safety of MiYOSMART iQ spectacle lenses with DIMS (Defocus Incorporated Multiple Segments) and Triple Enhanced Design (TED) technology in slowing myopia progression in children aged 8-11 years.\n\n35 children with myopia (spherical equivalent -0.5 to -6.0 D) will be prescribed MiYOSMART iQ lenses and followed for 6 months. The study will compare changes in spherical equivalent refraction and axial length against a historical control group (n=35) using ANCOVA. Secondary outcomes include measurements of peripheral refraction and contrast sensitivity at the first prescription.\n\nThe study hypothesis is that wearing MiYOSMART iQ lenses for 6 months significantly slows myopia progression compared to single-vision spectacle correction.', 'detailedDescription': 'Introduction and Scientific Rationale Progressive myopia in children is a global public health problem associated with an increased risk of ocular pathology in adulthood. Existing myopia control methods demonstrate efficacy, but there is a need for additional non-pharmacological, non-invasive approaches with a high safety profile and patient acceptability.\n\nMiYOSMART iQ spectacle lenses with DIMS and Triple Enhanced Design (TED) technology represent a modern method of optical myopia control, based on the concept of peripheral myopic defocus.\n\nThe efficacy of MiYOSMART lenses has been proven in a number of studies, primarily in Asian populations. However, some physiological aspects of their effect, especially in Caucasian populations and in real-world clinical practice, require further study:\n\nInsufficient data on the precise pattern of induced peripheral defocus when using open-field instruments.\n\nLack of studies on the effect of defocus segments on contrast sensitivity.\n\nNeed for evaluation of key parameter dynamics (refraction, AL) in Russian children.\n\nScientific Hypothesis: Wearing MiYOSMART iQ spectacles for 6 months leads to a statistically significant slowing of myopia progression (by SE and AL) compared to historical control and causes characteristic, measurable changes in peripheral refraction and contrast sensitivity parameters, detectable at first prescription.\n\nStudy Objectives and Endpoints\n\n\\- Primary Objective To evaluate the effect of MiYOSMART iQ spectacle lenses on myopia progression after 6 months of wear compared to a historical control group.\n\nPrimary Endpoints:\n\nChange in Spherical Equivalent of refraction (SE, D) under cycloplegia (Visit 3 - Visit 1).\n\nChange in Axial Length (AL, mm) (Visit 3 - Visit 1).\n\n\\- Secondary Objectives\n\nTo characterize the state of the visual system at the first prescription of MiYOSMART iQ lens correction.\n\nEndpoint 1: Peripheral refraction (D) indicators at various retinal points, measured with an open-field autorefractometer without correction and with new spectacles at Visit 2.\n\nEndpoint 2: Spatial contrast sensitivity (log units) indicators for various spatial frequencies, measured with the "Mesotest" device in a trial frame and with new spectacles at Visit 2.\n\nTo assess the tolerability and safety of MiYOSMART iQ lens correction over 6 months.\n\nEndpoint: Frequency, nature, and severity of all recorded Adverse Events (AEs) and Device Deficiencies (DDs).\n\nStudy Design and Methodology\n\n* Overall Design. Prospective, interventional, single-center study with a historical control group. Responsibility for conduct and scientific supervision rests with the Principal Investigator - Elena P. Tarutta.\n* Visits and Procedures. The overall schedule is presented below.\n\nVisit 1 (Day 0, Baseline): Informed Consent, Medical History; Visual Acuity (uncorrected, with habitual and optimal correction); Autorefractometry (narrow/wide pupil); Biometry (Axial Length); Binocular Vision, Phoria, AC/A Ratio; Choroidal Thickness Measurement; Recording of Adverse Events/Device Deficiencies.\n\nVisit 2 (within 3±1 weeks after V1): Visual Acuity with new MiYOSMART iQ spectacles; Contrast Sensitivity (Mesotest) in trial frame and new spectacles; Peripheral Refraction without correction and with new spectacles; Dispensing of MiYOSMART iQ spectacles; Recording of Adverse Events/Device Deficiencies.\n\nVisit 3 (Month 6±1 after V1): Visual Acuity with MiYOSMART iQ spectacles; Autorefractometry; Biometry (Axial Length); Binocular Vision, Phoria, AC/A Ratio; Choroidal Thickness Measurement; Recording of Adverse Events/Device Deficiencies.\n\n\\- Historical Control Group. Formed retrospectively from the research center\'s database. Includes patients who met the current study criteria and used single-vision spectacle correction for at least 6 months. Groups will be matched by age (±1 year) and baseline SE (±0.5 D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 8-11 years (inclusive)\n* Myopia: spherical equivalent -0.5 to -6.0 D under cycloplegia\n* No previous myopia control treatment\n* Orthophoria, presence of binocular vision\n\nExclusion Criteria:\n\n* Corrected visual acuity \\< 0.8 (decimal)\n* Anisometropia \\> 2.0 D\n* Strabismus history or presence\n* Previous refractive or intraocular surgery'}, 'identificationModule': {'nctId': 'NCT07387159', 'briefTitle': 'Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoya Lens Rus LLC'}, 'officialTitle': 'Prospective, Interventional, Single-center Study to Evaluate the Influence of MiYOSMART iQ Spectacle Lenses With DIMS and Triple Enhanced Design Technology on Refraction Dynamics, Biometric Parameters, Peripheral Refraction and Contrast Sensitivity in Children With Myopia', 'orgStudyIdInfo': {'id': 'MIYOSMART-iQ-OFT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MiYOSMART iQ intervention group', 'description': 'DIMS with Triple Enhanced Design technology', 'interventionNames': ['Device: MiYOSMART iQ spectacle lenses']}, {'type': 'NO_INTERVENTION', 'label': 'Historical control group', 'description': 'Retrospective data from patients with single-vision spectacle correction'}], 'interventions': [{'name': 'MiYOSMART iQ spectacle lenses', 'type': 'DEVICE', 'description': 'MiYOSMART iQ are single-vision spectacle lenses made of polycarbonate (refractive index 1.59) featuring Defocus Incorporated Multiple Segments (DIMS) technology with Triple Enhanced Design (TED). The lens contains a central optical zone for clear distance vision, surrounded by multiple, uniformly distributed micro-lens segments (diameter: \\~1.00 mm) that create a consistent myopic defocus signal of +4.50 D across the peripheral retina. This specific optical design aims to slow axial elongation in progressing myopia. The intervention involves full-time wear of spectacles with these lenses. The device is CE-marked and has Russian registration certificate No. ФСЗ 2012/11555 dated December 5, 2024', 'armGroupLabels': ['MiYOSMART iQ intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105062', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Tarutta, MD, PhD', 'role': 'CONTACT', 'email': 'Otdel_ref_bin2@igb.ru', 'phone': '+7(916)121-19-53'}], 'facility': 'Helmholtz National Medical Research Center of Eye Diseases', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Elena Tarutta, MD, PhD', 'role': 'CONTACT', 'email': 'Otdel_ref_bin2@igb.ru', 'phone': '+7(916)121-19-53'}, {'name': 'Nikolai Makukha', 'role': 'CONTACT', 'email': 'makuha@hoya.com', 'phone': '+7(968)88-55-942'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) underlying the results reported in this study will not be publicly shared due to sponsor's data management policies, restrictions in the study contract, and confidentiality considerations regarding pediatric patient data."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoya Lens Rus LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Helmholtz National Medical Research Center of Eye Diseases', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}