Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-30 @ 6:49 PM
Study NCT ID:
NCT05204095
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intelligent Cataract Screening With Portable Slit-lamp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The accuracy of referral', 'timeFrame': 'Baseline', 'description': 'The accuracy of referral of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.'}], 'secondaryOutcomes': [{'measure': 'The accuracy of cataract diagnosis', 'timeFrame': 'Baseline', 'description': 'The accuracy of cataract diagnosis of AI model will be calculated with the decisions based on the portable slit-lamp images with reference to the ground truth.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catarct Screening', 'Artificial Intelligence']}, 'descriptionModule': {'briefSummary': 'Based on the portable slit-lamp connected to the smartphone, the artificial intelligence machine learning algorithm is used to establish a cataract screening model by prospectively collecting the anterior segment photographic data, and a portable slit lamp intelligent screening referral model based on the smartphone connection is also established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The prospective population aged 0 to 100 with or without senile cataracts and received ocular examination.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 to 100 years old\n\nExclusion Criteria:\n\n* (1) History of eye disease except for age-related cataracts (2) History of eye trauma or eye surgery (3) Unable to cooperate with ophthalmology and general examination (4) Individuals with incomplete information (5) Unwilling to participate in this study'}, 'identificationModule': {'nctId': 'NCT05204095', 'acronym': 'AI', 'briefTitle': 'Intelligent Cataract Screening With Portable Slit-lamp', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Intelligent Cataract Screening With Portable Slit-lamp', 'orgStudyIdInfo': {'id': 'SLCS-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Referral group', 'description': 'The patients with severe cataracts in this group need a referral to a higher-level hospital for further treatment.', 'interventionNames': ['Device: Portable slit-lamp photography']}, {'label': 'Observation group', 'description': 'The patients with mild cataracts or transparent lenses in this group do not need a referral to a higher-level hospital for further treatment and keep regular examinations.', 'interventionNames': ['Device: Portable slit-lamp photography']}], 'interventions': [{'name': 'Portable slit-lamp photography', 'type': 'DEVICE', 'description': 'The enrolled patients will undergo portable slit-lamp photography with and without mydriasis and receive traditional slit-lamp photography for comparison.', 'armGroupLabels': ['Observation group', 'Referral group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Haotain Lin, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'gddlht@aliyun.com', 'phone': '+86-020-87330274'}], 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Haotian Lin, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'gddlht@aliyun.com', 'phone': '+86-020-87330274'}], 'overallOfficials': [{'name': 'Yizhi Liu, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}