Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-27 @ 9:19 AM
Study NCT ID:
NCT06269666
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P200TxE Diseased Eye Image Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of images', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Retinal Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective is to collect images on the P200TxE device in diseased eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed;\n2. Subjects who can follow the instructions by the clinical staff at the clinical site;\n3. Subjects who agree to participate;\n4. Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.\n\nFor glaucoma subjects:\n\na. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.\n\nExclusion Criteria:\n\n1. Subjects unable to tolerate ophthalmic imaging;\n2. Subjects with ocular media not sufficiently clear to obtain acceptable images.'}, 'identificationModule': {'nctId': 'NCT06269666', 'briefTitle': 'P200TxE Diseased Eye Image Collection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optos, PLC'}, 'officialTitle': 'P200TxE Diseased Eye Image Collection', 'orgStudyIdInfo': {'id': 'OPT1100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Imaging Session', 'description': 'Various scans will be captured', 'interventionNames': ['Device: P200TxE']}], 'interventions': [{'name': 'P200TxE', 'type': 'DEVICE', 'description': 'SLO and OCT imaging', 'armGroupLabels': ['Imaging Session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40215', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Kingdon', 'role': 'CONTACT', 'email': 'megankingdon@eyecare-partners.com', 'phone': '513-305-8654'}], 'facility': 'Bennett and Bloom Eye Centers', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optos, PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}