Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04921020
Status:
RECRUITING
Last Update Posted:
2021-06-10
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005141', 'term': 'Eyelid Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010781', 'term': 'Photography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2021-06-01', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one-dimensional parameters of eyelid topology', 'timeFrame': 'through study completion, 5 years', 'description': 'Palpebral fissure length \\[Margin reflex distance 1, Margin reflex distance 2\\], Lid length \\[Upper lid length, Lower lid length\\], Multiple mid-pupil lid distances'}, {'measure': 'two-dimensional parameters of eyelid topology', 'timeFrame': 'through study completion, 5 years', 'description': 'Palpebral fissure area \\[Medial area, Corneal area, Lateral area\\]'}, {'measure': 'subtypes of levator function', 'timeFrame': 'through study completion, 5 years', 'description': 'Levator function is classified into three categories: good, fair and poor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eyelid Diseases']}, 'descriptionModule': {'briefSummary': 'This study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "100 normal volunteers without eyelid diseases 100 patients with blepharoptosis 100 patients with blepharospasm 100 patients with dry eye disease 100 patients with Graves' disease", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. normal volunteers without eyelid diseases\n2. patients with blepharoptosis\n3. patients with blepharospasm\n4. patients with dry eye disease\n5. patients with Graves' disease\n\nExclusion Criteria:\n\nvariable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil"}, 'identificationModule': {'nctId': 'NCT04921020', 'briefTitle': 'Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Department of Ophthalmology', 'orgStudyIdInfo': {'id': '2020-485'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal participants', 'interventionNames': ['Other: Photography']}, {'label': 'Patients with blepharoptosis', 'interventionNames': ['Other: Photography']}, {'label': 'Patients with blepharospasm', 'interventionNames': ['Other: Photography']}, {'label': 'Patients with dry eye disease', 'interventionNames': ['Other: Photography']}, {'label': "Patients with Graves' disease", 'interventionNames': ['Other: Photography']}], 'interventions': [{'name': 'Photography', 'type': 'OTHER', 'description': 'Facial photographs and blinking videos are taken', 'armGroupLabels': ['Normal participants', "Patients with Graves' disease", 'Patients with blepharoptosis', 'Patients with blepharospasm', 'Patients with dry eye disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Ye', 'role': 'CONTACT', 'email': 'yejuan@zju.edu.cn', 'phone': '+86-571-87783897'}], 'facility': 'Juan Ye', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Juan Ye', 'role': 'CONTACT', 'email': 'yejuan@zju.edu.cn', 'phone': '+86-571-87783897'}, {'name': 'Lixia Lou', 'role': 'CONTACT', 'email': 'loulixia110@zju.edu.cn', 'phone': '+86-15088681589'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}