Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-02 @ 1:15 AM
Study NCT ID:
NCT05288335
Status:
UNKNOWN
Last Update Posted:
2022-12-28
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-25', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in ocular axial length in a year', 'timeFrame': 'baseline, 12 months', 'description': 'The ocular axial length was measured by AL-scan'}], 'secondaryOutcomes': [{'measure': 'Changes in cycloplegic objective spherical equivalent in a year', 'timeFrame': 'baseline, 12 months', 'description': 'The cycloplegic objective spherical equivalent was evaluated by a autorefractor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '33811039', 'type': 'BACKGROUND', 'citation': 'Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.'}, {'pmid': '38429067', 'type': 'DERIVED', 'citation': 'Muller J, Chen X, Ohlendorf A, Li L, Wahl S. Method comparison and overview of refractive measurements in children: implications for myopia management. BMJ Open Ophthalmol. 2024 Mar 1;9(1):e001322. doi: 10.1136/bmjophth-2023-001322.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia', 'detailedDescription': 'Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.\n\nPrimary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 6-13 years old;\n2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;\n3. Monocular best corrected visual acuity (VA) of 1.0 or better;\n4. Acceptance of random group allocation and the masked study design\n5. Voluntarily participate in the clinical trial and sign the informed consent;\n\nExclusion Criteria:\n\n1. Strabismus.\n2. Ocular and systemic abnormalities.\n3. Prior experience of myopia control.\n4. Only one eye meets the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05288335', 'briefTitle': 'Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia', 'orgStudyIdInfo': {'id': 'TianjinEH-myopia progression'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Circular cylindrical mirror modulated frame glasses (compact)', 'description': 'Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.', 'interventionNames': ['Device: Circular cylindrical mirror modulated frame glasses (compact)']}, {'type': 'EXPERIMENTAL', 'label': 'Circular cylindrical mirror modulated frame glasses (strong defocus)', 'description': 'Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.', 'interventionNames': ['Device: Circular cylindrical mirror modulated frame glasses (strong defocus)']}, {'type': 'EXPERIMENTAL', 'label': 'single vision frame glasses', 'description': 'Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.', 'interventionNames': ['Device: single vision frame glasses']}], 'interventions': [{'name': 'Circular cylindrical mirror modulated frame glasses (compact)', 'type': 'DEVICE', 'description': 'Circular cylindrical mirror modulated frame glasses (compact)', 'armGroupLabels': ['Circular cylindrical mirror modulated frame glasses (compact)']}, {'name': 'Circular cylindrical mirror modulated frame glasses (strong defocus)', 'type': 'DEVICE', 'description': 'Circular cylindrical mirror modulated frame glasses (strong defocus)', 'armGroupLabels': ['Circular cylindrical mirror modulated frame glasses (strong defocus)']}, {'name': 'single vision frame glasses', 'type': 'DEVICE', 'description': 'single vision frame glasses', 'armGroupLabels': ['single vision frame glasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Xiaoqin Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}