Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04910451
Status:
UNKNOWN
Last Update Posted:
2021-06-02
First Post:
2021-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'axial length', 'timeFrame': '1 year', 'description': 'changes in axial length'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthokeratology', 'myopia control'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To investigate the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors in China', 'detailedDescription': 'Patients who were successfully prescribed with orthokeratology lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine were enrolled in the study. Our study used two different methods to collect data. For complications and effect of orthokeratology information, data were collected by a retrospective survey. A questionnaire was used to collect influencing factors of safety and effect of orthokeratology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'myopia patients who were using orthokeratology for myopia control', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were successfully prescribed with ortho-k lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine\n\nExclusion Criteria:\n\n* Patients who have ceased wearing orthokeratology or who were using other methods of myopia control'}, 'identificationModule': {'nctId': 'NCT04910451', 'briefTitle': 'Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors', 'orgStudyIdInfo': {'id': '2020-448'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No Intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiwen Bian, doctor', 'role': 'CONTACT', 'email': 'bianzhiwen87@163.com', 'phone': '+86 13588083734'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhiwen Bian, doctor', 'role': 'CONTACT', 'email': 'bianzhiwen87@163.com', 'phone': '+86 13588083734'}, {'name': 'Hailing Ni, doctor', 'role': 'CONTACT', 'email': '2101092@zju.edu.cn', 'phone': '+86-571-87783897'}], 'overallOfficials': [{'name': 'Zhiwen Bian, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}