Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT06647160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-23
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of lens thickness (LT) at two years', 'timeFrame': '2 years', 'description': 'The difference of LT (mm) at two years compared with baseline LT. LT will be measured by IOLMaster-700.'}, {'measure': 'Change of corneal power (CP) at two years', 'timeFrame': '2 years', 'description': 'The difference of CP (diopter) at two years compared with baseline CP. CP will be measured by IOLMaster-700.'}, {'measure': 'Best corrected visual acuity at two years', 'timeFrame': '2 years', 'description': 'Best corrected visual acuity will be measured at baseline and two years by EDTRS visual acuity chart.'}, {'measure': 'Binocular visual function at two years', 'timeFrame': '2 years', 'description': 'Binocular visual function which is a qualitative outcome assessed by a series of tests will be measured every half year.'}, {'measure': 'Change of choroidal thickness at two years', 'timeFrame': '2 years', 'description': 'The difference of Choroidal thickness (μm) at two years compared with baseline measure. Choroidal thickness will be measured by OCTA.'}], 'primaryOutcomes': [{'measure': 'Changes of spherical equivalent refraction (SER) at two years', 'timeFrame': '2 years', 'description': 'The difference of SER (Diopter) at two years compared with baseline SER. SER will be measured after cycloplegia.'}], 'secondaryOutcomes': [{'measure': 'Changes of axial length (AL) at two years', 'timeFrame': '2 years', 'description': 'The difference of AL (mm) at two years compared with baseline AL. AL will be measured by IOLMaster-700.'}, {'measure': 'Visual scale score at two years', 'timeFrame': '2 years', 'description': 'Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) is scaled from 0 (poor quality of life) to 100 (good quality of life).'}, {'measure': 'Incidence of adverse event during study period', 'timeFrame': '2 years', 'description': "Adverse event is a comprehensive qualitative outcome measure that will be evaluated based on the participants' symptoms and signs, intraocular pressure, slit lamp and fundus examinations, as well as lens and frame damage. The evaluation will be conducted every six months according to the predetermined definition of abnormalities in the above examinations."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['concentric columnar microstructure', 'Myopia control'], 'conditions': ['Myopia, Progressive']}, 'descriptionModule': {'briefSummary': 'The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 8 to 11 years;\n* Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;\n* Best-corrected visual acuity of equal or better than 0.00 LogMAR (\\>= 1.0 as Snellen).\n* The intraocular pressure of 10 to 21mmHg.\n* Volunteer to participate in this clinical trial with signature of the informed consent form.\n\nExclusion Criteria:\n\n* History of eye injury or intraocular surgery;\n* Clinically abnormal slit-lamp findings\n* Abnormal fundus examination\n* Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;\n* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);\n* Participation of the drug clinical trial within three month and the device clinical trial within one month;\n* Only one eye meets the inclusion criteria;\n* Unable to have regular follow-up\n* Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc."}, 'identificationModule': {'nctId': 'NCT06647160', 'briefTitle': 'Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'Safety and Efficacy of Blue Star MAX-5 Lenses in Mvopia Control: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2024KYPJ115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Blue star MAX-5 spectacle lens', 'interventionNames': ['Device: Blue star MAX-5 spectacle lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Single-vision spectacle lens', 'interventionNames': ['Device: Single-vision spectacle lens']}], 'interventions': [{'name': 'Blue star MAX-5 spectacle lens', 'type': 'DEVICE', 'description': 'The children in the experimental group will wear Blue star MAX-5 spectacle lens and receive follow-up examinations every half year.', 'armGroupLabels': ['Intervention']}, {'name': 'Single-vision spectacle lens', 'type': 'DEVICE', 'description': 'The children in the single-vision lenses group will wear single-vision spectacle lens and receive follow-up examinations every half year.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jian Ge', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}