Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-01 @ 12:32 AM
Study NCT ID:
NCT04972695
Status:
COMPLETED
Last Update Posted:
2022-02-28
First Post:
2021-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 615}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of an automated classification system for retinographies', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Learning', 'Diagnoses Disease', 'Glaucoma', 'retinographies'], 'conditions': ['Glaucoma, Suspect', 'Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'Clinical, cross-sectional and prospective study to assess the images of the posterior pole of the retina of patients from the Glaucoma Unit of the IOBA and the Hospital Clínico Universitario de Valladolid during the period between May and December 2021.\n\nThe aim of the project is to provide a sufficient number of images from posterior pole retinographies in patients with suspected glaucoma or with diagnosis of glaucoma in order to determine the sensitivity and specificity of an automatic glaucoma screening algorithm developed by the company Transmural Biotech S.L.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ocular hypertensive patients or patients with diagnosis of Glaucoma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open angle glaucoma or ocular hypertension\n* Signed informed consent\n* Visual field examination within the last 12 months\n\nExclusion Criteria:\n\n* Ocular or systemic pathologies that may interfere with the quality of the retinographic image or the results of the visual field\n* Congenital anomalies of the papilla that seriously alter its structure\n* High ametropia (\\> 10 diopters)\n* Pharmacological Mydriasis contraindication.'}, 'identificationModule': {'nctId': 'NCT04972695', 'briefTitle': 'Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA'}, 'officialTitle': 'Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images', 'orgStudyIdInfo': {'id': 'PI 21-2278'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma', 'description': 'People with diagnosis of Primary Open Angle Glaucoma (POAG)', 'interventionNames': ['Diagnostic Test: Fundus Photographs (retinographies)']}, {'label': 'Ocular Hypertension / glaucoma suspect', 'description': 'People with diagnosis of Ocular Hypertension or POAG suspicion', 'interventionNames': ['Diagnostic Test: Fundus Photographs (retinographies)']}], 'interventions': [{'name': 'Fundus Photographs (retinographies)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fundus photographs under mydriasis', 'armGroupLabels': ['Glaucoma', 'Ocular Hypertension / glaucoma suspect']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47011', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'IOBA - Universidad de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}