Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06211218
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence for Screening of Multiple Corneal Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under curve', 'timeFrame': '1 week', 'description': 'We used the receiver operating characteristic (ROC) curve and area under curve to examine the ability of this artificial intelligence algorism recognition and classification of corneal diseases.'}, {'measure': 'Sensitivity and specificity', 'timeFrame': '1 week', 'description': 'We used sensitivity and specificity to examine the ability of this artificial intelligence algorism recognition and classification of corneal diseases.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Learning', 'Corneal Disease', 'Screening']}, 'descriptionModule': {'briefSummary': 'This study developed a deep learning algorithm based on anterior segment images and prospectively validated its ability to identify corneal diseases.The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is derived from an anonymous database that contains health examination results of the general population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The quality of slit-lamp images should clinical acceptable.\n2. More than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate.\n\nExclusion Criteria:\n\n1）Insufficient information for diagnosis.'}, 'identificationModule': {'nctId': 'NCT06211218', 'briefTitle': 'Artificial Intelligence for Screening of Multiple Corneal Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'Application of Deep Learning for Screening Multiple Corneal Diseases', 'orgStudyIdInfo': {'id': 'KY-2023083'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cornea diseases diagnosed by artificial intelligence algorithm', 'interventionNames': ['Diagnostic Test: Cornea diseases diagnosed by artificial intelligence algorithm']}], 'interventions': [{'name': 'Cornea diseases diagnosed by artificial intelligence algorithm', 'type': 'DIAGNOSTIC_TEST', 'description': 'An artificial intelligence algorithm was applied to diagnose cornea diseases from slit-lamp images.', 'armGroupLabels': ['Cornea diseases diagnosed by artificial intelligence algorithm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tiajin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Yan Huo, Master', 'role': 'CONTACT', 'email': 'hy13102118953@163.com', 'phone': '13102118953'}], 'overallOfficials': [{'name': 'Yan Wang, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}