Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04302220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2020-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myopic Optic Neuropathy in Chinese High Myopia Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva smple.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 813}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2020-03-07', 'studyFirstSubmitQcDate': '2020-03-07', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of glaucoma within 36 months', 'timeFrame': '3 years', 'description': 'Structural and functional changes of glaucoma using visual field, stereoscopic fundus photography.'}], 'secondaryOutcomes': [{'measure': 'Progression of myopia and other structural changes of retina and choroid.', 'timeFrame': '3 years', 'description': 'Structural and functional changes of myopia based on axial length and refractive error.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['myopic optic neuropathy', 'high myopia', 'glaucoma'], 'conditions': ['Eye Diseases']}, 'referencesModule': {'references': [{'pmid': '35288144', 'type': 'DERIVED', 'citation': 'Lin F, Chen S, Song Y, Li F, Wang W, Zhao Z, Gao X, Wang P, Jin L, Liu Y, Chen M, Liang X, Yang B, Ning G, Cheng CY, Healey PR, Park KH, Zangwill LM, Aung T, Ohno-Matsui K, Jonas JB, Weinreb RN, Zhang X; Glaucoma Suspects with High Myopia Study Group. Classification of Visual Field Abnormalities in Highly Myopic Eyes without Pathologic Change. Ophthalmology. 2022 Jul;129(7):803-812. doi: 10.1016/j.ophtha.2022.03.001. Epub 2022 Mar 12.'}, {'pmid': '33380478', 'type': 'DERIVED', 'citation': 'Song Y, Wang W, Lin F, Chen S, Jin L, Li F, Gao K, Cheng W, Xiong J, Zhou R, Chen M, Liang J, Zhang J, Jonas JB, Zhang X. Natural history of glaucomatous optic neuropathy in highly myopic Chinese: study protocol for a registry cohort study. BMJ Open. 2020 Dec 30;10(12):e039183. doi: 10.1136/bmjopen-2020-039183.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.', 'detailedDescription': 'Global prevalence of high myopia brings about markedly increasing of blinding complications as myopic optic neuropathy (MON) and glaucoma. It was estimated that there were 163 million people who have high myopia in 2000, and the population with high myopia would increase to almost one billion (9.8% of the world population) worldwide by 2050.\n\nGlaucoma is the leading cause of irreversible blindness worldwide while it is difficult to distinguish glaucoma among MON in high myopia eyes. However, there lack longitudinal study to illustrate the natural course interpreting the distribution and natural history of MON.\n\nIn view of the above problems, this is a longitudinal registry cohort study to observe the long-term changes of structural and functional parameters of MON in high myopia, and to investigate the natural course and associted risk factors that influence the progression in a Chinese adult population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have high myopia aged from 18 to above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥18 years\n* Equivalent spherical ≤-6D or axial length ≥26.5mm\n* Best corrected visual acuity ≥ 6/12\n\nExclusion Criteria\n\n* Unwilling or unable to give consent, or unable to return for scheduled protocol visits.\n* Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease.\n* Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia.\n* Need for ocular surgery/laser or anticipated need for cataract surgery during the study period.\n* Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases);\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT04302220', 'briefTitle': 'Myopic Optic Neuropathy in Chinese High Myopia Population', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Natural History of Myopic Optic Neuropathy for High Myopia in Chinese Adult Population: a Registry Cohort Study', 'orgStudyIdInfo': {'id': '2019KYPJ079'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high myopia', 'description': 'Population who have high myopia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xiulan Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology, Director of Clinical Research Center, Director of CFDA-certified Pharmaceutical Research Unit, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center', 'investigatorFullName': 'Xiulan Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}