Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 7:51 AM
Study NCT ID:
NCT05756959
Status:
RECRUITING
Last Update Posted:
2023-03-09
First Post:
2023-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Control Combined PBM With Myopic Defocus Lens in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047728', 'term': 'Myopia, Degenerative'}], 'ancestors': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2023-02-05', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Event', 'timeFrame': '6 month', 'description': 'Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period'}], 'primaryOutcomes': [{'measure': 'axial length (mm)', 'timeFrame': '6 month', 'description': 'Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time.\n\nChanges in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.'}, {'measure': 'SE (Diopter, D)', 'timeFrame': '6 month', 'description': 'changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.'}], 'secondaryOutcomes': [{'measure': 'UCVA (logMar visual acuity record)', 'timeFrame': '6 month', 'description': 'Uncorrected visual acuity will be measured under 5-meter distance logMar Visual acuity chart without any aid （including the spectacles or contact lens) at baseline and at follow-up'}, {'measure': 'BCVA (logMar visual acuity record)', 'timeFrame': '6 month', 'description': 'Best corrected visual acuity will be measured under the same 5-meter distance logMar Visual acuity as the UCVA both at baseline and at follow-up.'}, {'measure': 'OCT', 'timeFrame': '6-month', 'description': 'Opitcal coherence tomography(OCT) record\n\nThe marcular sturcture and image scanned by the optical coherent topography will be measured by linear scan at the marcular by the same Optical coherence tomography with the same examiner and the same instrument both at baseline and at follow-up'}, {'measure': 'SFCT （um)', 'timeFrame': '6-month', 'description': 'Sub-forveal choroidal thickness will be measured with the same software in the same Optical coherence tomography (OCT) at the location from the foveal center manually'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia, Progressive']}, 'descriptionModule': {'briefSummary': 'To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.', 'detailedDescription': 'myopic children with age from 6 \\~13 years old. And refraction from -0.50D\\~-5.50D.\n\nThe red light is low lever laser therapy at wavelength of 650nm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent by the supervision of the children\n* 6\\~13 years old (including both the 6 and 13)\n* SE range: -0.50\\~-5.50D\n* Astigmatism \\<=2.00D\n* BCVA \\>=0.8\n* Anisometropia \\<=1.50D\n* Confirmed to no use of other myopia control intervention\n\nExclusion Criteria:\n\n* Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)\n* Halo, glare, toutic, ADHD, psoriasis\n* Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.\n* Squint, ocular lesion or acute imflammation.\n* Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.'}, 'identificationModule': {'nctId': 'NCT05756959', 'briefTitle': 'Myopia Control Combined PBM With Myopic Defocus Lens in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Airdoc Technology Co., Ltd.'}, 'officialTitle': 'Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month', 'orgStudyIdInfo': {'id': "Xuzhou First People's Hospital"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBM therapy + SVS', 'description': 'Low lever red light therapy with single vision spectacles', 'interventionNames': ['Device: PBM', 'Device: Single vision spectacles']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral defocus spectacles', 'description': 'a spectacles with special design with peripheral myopic defocus to control myopia progression', 'interventionNames': ['Device: Peripheral defocus spectacles']}, {'type': 'EXPERIMENTAL', 'label': 'PBM +Peripheral defocus spectacles', 'description': 'Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression', 'interventionNames': ['Device: PBM', 'Device: Peripheral defocus spectacles']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'single vision spectacles only as the control', 'interventionNames': ['Device: Single vision spectacles']}], 'interventions': [{'name': 'PBM', 'type': 'DEVICE', 'otherNames': ['Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy'], 'description': 'PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia', 'armGroupLabels': ['PBM +Peripheral defocus spectacles', 'PBM therapy + SVS']}, {'name': 'Peripheral defocus spectacles', 'type': 'DEVICE', 'otherNames': ['Myopic defocus spectacles for myopia control'], 'description': 'plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina', 'armGroupLabels': ['PBM +Peripheral defocus spectacles', 'Peripheral defocus spectacles']}, {'name': 'Single vision spectacles', 'type': 'DEVICE', 'otherNames': ['single vision glasseses for myopia correction lenses'], 'description': 'Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)', 'armGroupLabels': ['Control', 'PBM therapy + SVS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Li, MD.Ph.D.', 'role': 'CONTACT', 'email': '834582241@qq.com', 'phone': '+8615162130727'}, {'name': 'Weiming Yang, MD. PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiaoying Wang, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xingtao Zhou, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "the first people's hospital of Xuzhou", 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Ying Li, MD, PHD', 'role': 'CONTACT', 'email': '834582241@qq.com', 'phone': '+8615162130727'}, {'name': 'Lei Qiao, PHD, MD', 'role': 'CONTACT', 'phone': '+15162127602'}], 'overallOfficials': [{'name': 'Yan Wang, BA', 'role': 'STUDY_DIRECTOR', 'affiliation': "The First People's Hospital of Xuzhou"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Airdoc Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "The First People's Hospital of Xuzhou", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}