Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-30 @ 8:27 PM
Study NCT ID:
NCT06185868
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research Plan for Human Myopia Models
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples Without DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-15', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refraction', 'timeFrame': '7 months', 'description': 'Units of measurement:Diopter; measurement tool: subjective refraction;'}, {'measure': 'Whole eye aberration', 'timeFrame': '7 months', 'description': 'Units of measurement:micorn; measurement tool: Visual quality analyzer;'}, {'measure': 'Pupil diameter', 'timeFrame': '7 months', 'description': 'Units of measurement:millimetre; measurement tool Visual quality analyzer;'}, {'measure': 'Eye axis length', 'timeFrame': '7 months', 'description': 'Units of measurement:millimetre; measurement tool: IOLMaster 700(ZEISS)'}, {'measure': 'Corneal anterior and posterior surface curvature', 'timeFrame': '7 months', 'description': 'Units of measurement:Diopter; measurement tool: Petacam HR'}, {'measure': 'Corneal thickness', 'timeFrame': '7 months', 'description': 'Units of measurement:millimetre; measurement tool: Petacam HR'}, {'measure': 'Anterior Chamber Depth', 'timeFrame': '7 months', 'description': 'Units of measurement:millimetre; measurement tool: Petacam HR'}, {'measure': 'Corrected Visual Acuity', 'timeFrame': '7 months', 'description': 'Units of measurement:NA; measurement tool: subjective refraction;'}, {'measure': 'Intraocular Pressure', 'timeFrame': '7 months', 'description': 'Units of measurement:millimeters of mercury height; measurement tool: Tonometer (NT-510)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Myopia Model']}, 'descriptionModule': {'briefSummary': 'Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.', 'detailedDescription': 'Experimental research purpose:Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.\n\nCase selection: This study requires the inclusion of children and adolescents aged between 4 and 18 years who have been diagnosed with myopia and refractive errors through medical examination of dilated pupils.\n\nPlan: Collect eye parameters such as refractive power, whole eye aberration, corrected visual acuity, pupil diameter, axial length, anterior and posterior corneal surface curvature, and corneal thickness of all subjects under 9 non dilated stimuli.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruited volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Selection criteria:\n\n1. Gender unlimited\n2. Age 6-16 years old\n3. Through medical optometry with dilated pupils, the spherical equivalent refractive index is within the range of -0.5DS\\~-8.0DS, and the cylindrical lens is ≤ -0.75DC\n\nExclusion criteria:\n\n1. Patients with corneal diseases such as corneal ulcers, corneal opacities, and corneal leukoplakia\n2. Patients with refractive media opacity, such as cataracts and vitreous hemorrhage\n3. Glaucoma patients\n4. Patients with nystagmus\n5. Patients with strabismus and amblyopia\n6. Patients with fundus diseases\n7. Patients with a column mirror range greater than -0.75DC\n8. Patients with binocular anisometropia ≥ 1.0D\n9. Corneal contact lenses (such as corneal reshaping lenses, multifocal contact lenses, and RGP) with a history of wearing\n10. Long term history of low concentration atropine and other ocular medications\n11. Wearing history of functional lenses such as asymptotic multifocal, multi-point myopic defocus, peripheral defocus, etc\n12. Patients participating in other eye clinical trials\n13. Individuals with mental illness or cognitive impairment who are unable to cooperate\n\n * Researchers believe that other reasons are not suitable for clinical trial participants, such as poor physical condition on the day of the trial'}, 'identificationModule': {'nctId': 'NCT06185868', 'briefTitle': 'Clinical Research Plan for Human Myopia Models', 'organization': {'class': 'INDUSTRY', 'fullName': 'Robotrak Technologies Co., Ltd.'}, 'officialTitle': 'Clinical Research Plan for Human Myopia Models', 'orgStudyIdInfo': {'id': 'RYMX202201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention measures', 'type': 'OTHER', 'description': 'No intervention measures'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'country': 'China', 'facility': 'Robotrak Technologies Co., Ltd.', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robotrak Technologies Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}