Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-02 @ 9:27 AM
Study NCT ID:
NCT06523504
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 410}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-30', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity', 'timeFrame': 'up to 24 months', 'description': 'Best Corrected Visual Acuity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.', 'detailedDescription': 'In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* School-age children aged 6 to 12 years (including boundary value)\n* Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)\n* Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)\n* Agree with the study scheme and sign the informed consent\n* Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.\n\nExclusion Criteria:\n\n* Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past\n* Children with obvious strabismus and amblyopia\n* With congenital eye disease, such as congenital cataract, congenital retinal disease\n* Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)\n* Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)\n* Refractive medium opacity (such as corneal disease, crystal opacity, etc.)\n* Bnormal intraocular pressure and clinical significance (IOP \\<10 mmHg or IOP \\>21mmHg or binocular IOP difference ≥5mmHg)\n* Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases\n* Optic nerve damage or congenital optic nerve dysfunction\n* Can not be regularly checked\n* The adjustment range is less than 8D or obvious near difficulties\n* Other reasons researchers think it is not suitable for inclusion in researchers'}, 'identificationModule': {'nctId': 'NCT06523504', 'acronym': 'atropine', 'briefTitle': 'Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Eye Hospital'}, 'officialTitle': 'Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control', 'orgStudyIdInfo': {'id': '2019yj001J-5'}, 'secondaryIdInfos': [{'id': '2019yj001J-5', 'type': 'OTHER_GRANT', 'domain': 'Beijing Bethune Charitable Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The DIMS Group', 'description': 'wear DIMS ,and use placebo,once nightly, both eye', 'interventionNames': ['Device: DIMS']}, {'type': 'EXPERIMENTAL', 'label': '0.02% ATP', 'description': 'wear SP, and use 0.02%ATP eye drops, once nightly, both eye', 'interventionNames': ['Drug: The 0.02% ATP Group']}, {'type': 'EXPERIMENTAL', 'label': '0.04%ATP', 'description': 'wear SP, and use 0.04%ATP eye drops, once nightly, both eye', 'interventionNames': ['Drug: The 0.04% ATP Group']}, {'type': 'EXPERIMENTAL', 'label': '0.02%ATP+DIMS', 'description': 'wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye', 'interventionNames': ['Combination Product: 0.02%ATP+DIMS']}, {'type': 'EXPERIMENTAL', 'label': '0.04%ATP+DIMS', 'description': 'wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye', 'interventionNames': ['Combination Product: 0.04%ATP+DIMS']}], 'interventions': [{'name': 'DIMS', 'type': 'DEVICE', 'description': 'wear DIMS ,and use placebo,once nightly, both eye', 'armGroupLabels': ['The DIMS Group']}, {'name': 'The 0.02% ATP Group', 'type': 'DRUG', 'description': 'wear SP, and use 0.02%ATP eye drops, once nightly, both eye', 'armGroupLabels': ['0.02% ATP']}, {'name': 'The 0.04% ATP Group', 'type': 'DRUG', 'description': 'wear SP, and use 0.04%ATP eye drops, once nightly, both eye', 'armGroupLabels': ['0.04%ATP']}, {'name': '0.02%ATP+DIMS', 'type': 'COMBINATION_PRODUCT', 'description': 'wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye', 'armGroupLabels': ['0.02%ATP+DIMS']}, {'name': '0.04%ATP+DIMS', 'type': 'COMBINATION_PRODUCT', 'description': 'wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye', 'armGroupLabels': ['0.04%ATP+DIMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120120', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meinan He', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Meinan He', 'role': 'CONTACT', 'email': 'hmn509@tmu.edu.cn', 'phone': '+8613672135765'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruihua Wei', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruihua Wei', 'investigatorAffiliation': 'Tianjin Medical University Eye Hospital'}}}}