Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT05538793
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2022-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Learning for the Discrimination Among Different Types of Keratits: a Nationwide Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007634', 'term': 'Keratitis'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10369}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2022-09-11', 'studyFirstSubmitQcDate': '2022-09-11', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the receiver operating characteristic curve of the deep learning system', 'timeFrame': '2020-2022'}], 'secondaryOutcomes': [{'measure': 'Accuracy of the deep learning system', 'timeFrame': '2020-2022'}, {'measure': 'Sensitivity of the deep learning system', 'timeFrame': '2020-2022'}, {'measure': 'Specificity of the deep learning system', 'timeFrame': '2020-2022'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keratitis', 'Slit-lamp Image', 'Deep Learning'], 'conditions': ['Keratitis', 'Automatic Judgement', 'Image']}, 'descriptionModule': {'briefSummary': 'Detecting the cause of keratitis fast is the premise of providing targeted therapy for reducing vision loss and preventing severe complications. Due to overlapping inflammatory features, even expert cornea specialists have relatively poor performance in the identification of causative pathogen of infectious keraitis. In this project, the investigators aim to develop an automated and accurate deep learning system to discriminate among bacterial, fungal, viral, amebic and noninfectious keratitis based on slit-lamp images and evaluated this system using the datasets obtained from mutiple independent clinical centers across China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Week', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Child, Adult, Older Adult', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSlit-lamp images with sufficient diagnostic certainty and showing keratitis at the active phase.\n\nExclusion Criteria:\n\n* Poor-quality images\n* Images presenting mixed infections (i.e., cornea infected by two or more causative pathogens)'}, 'identificationModule': {'nctId': 'NCT05538793', 'briefTitle': 'Deep Learning for the Discrimination Among Different Types of Keratits: a Nationwide Study', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo Eye Hospital'}, 'officialTitle': 'Deep Learning for the Discrimination Among Bacterial, Fungal, Viral, Amebic and Noninfectious Keratitis: a Nationwide Study', 'orgStudyIdInfo': {'id': 'NEH2022091015'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo Eye Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Wenzhou', 'country': 'China', 'facility': 'Eye Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}