Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 7:55 AM
Study NCT ID:
NCT04275635
Status:
UNKNOWN
Last Update Posted:
2020-03-16
First Post:
2020-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUROC of the prediction algorithm for identifying fast progressing myopes', 'timeFrame': '1 year', 'description': 'Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes', 'timeFrame': '1 year', 'description': 'The investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes.'}, {'measure': 'Performance of an algorithm for predicting AL', 'timeFrame': '1 year', 'description': 'The investigators will use mean absolute error (MAE), R square to evaluate the performance.'}, {'measure': 'Performance of an algorithm for predicting spherical equivalent refractive error', 'timeFrame': '1 year', 'description': 'The investigators will use mean absolute error (MAE), R square to evaluate the performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '21896861', 'type': 'BACKGROUND', 'citation': 'Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.', 'detailedDescription': 'Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '3,000 children from Zhongshan Ophthalmic Center plan to wear orthokeratology lenses for myopia control.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -6.0D≤SER≤-0.5D\n* Astigmatism≤2.0D\n\nExclusion Criteria:\n\n* Contraindications of wearing Ortho-K.\n* Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.\n* Currently involved in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT04275635', 'briefTitle': 'Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control', 'orgStudyIdInfo': {'id': '2020KYPJ018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with myopia', 'description': 'A total of 3,000 children from Zhongshan Ophthalmic Center is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing Ortho-K.', 'interventionNames': ['Device: Orthokeratology lenses']}], 'interventions': [{'name': 'Orthokeratology lenses', 'type': 'DEVICE', 'description': 'Orthokeratology lenses', 'armGroupLabels': ['Children with myopia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingfeng Zheng, M.D, Ph.D', 'role': 'CONTACT', 'email': 'zhyfeng@mail.sysu.edu.cn', 'phone': '+8613922286455'}], 'facility': 'Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yingfeng Zheng, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'zhyfeng@mail.sysu.edu.cn', 'phone': '+8613922286455'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical investigator', 'investigatorFullName': 'Yingfeng Zheng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}