Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 7:17 AM
Study NCT ID:
NCT06976034
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
oCular Examination at Cell RESolution With Optical TransmissionTomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, exploratory, longitudinal, non-randomized, single-center study including patients and healthy volunteers.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-11-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': 'between 1 day and 4 years', 'description': 'Quality assessed by two blinded experts.\n\nThis is an evaluation of image quality in terms of operation according to the following scheme.\n\nQuality assessment:\n\n\\- Sufficient quality : Yes Or No\n\nIf no, tick yes, below and fill in the cause:\n\nInsufficient quality: ☒ yes ☐ no\n\nCause:\n\n* Technical problem Or\n* Patient-related problem (inability to fix, or comply with procedure, etc.)'}, {'measure': 'Endothelial cell density', 'timeFrame': 'between 1 day and 4 years', 'description': 'Assessment of endothelial cell density.'}, {'measure': 'Imaging new corneal and lens structures', 'timeFrame': 'between 1 day and 4 years', 'description': 'corneal and lens structures:measure density in other cell types'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma Associated With Other Ocular Disorders']}, 'descriptionModule': {'briefSummary': 'Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.', 'detailedDescription': 'For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions.\n\nFor patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Patients:\n\n* 200 subjects aged 18 to 80 years;\n* Male or female;\n* with an ocular disease affecting the cornea, ocular surface, lens (cataract) or glaucoma, or requiring refractive surgery or post-refractive surgery follow-up;\n* Are covered by the French Assurance Maladie;\n* Have signed an express, free and informed consent form.\n\nFor Healthy volunteers:\n\n* 100 subjects aged 18 to 80 years;\n* Male or female;\n* Healthy subjects with no known pathology directly or indirectly affecting ocular structures;\n* Covered by the French Assurance Maladie.\n* Having signed an express, free and informed consent form.\n\nExclusion Criteria:\n\nFor all participants:\n\n* Inability to hold a still position on a standard ophthalmic chin rest;\n* Conjunctivitis or other contagious contact disease in active phase;\n* Having an implanted pacemaker or other electronic medical device;\n* Having a predisposition to iridocorneal angle closure;\n* Vulnerable persons or persons under legal protection (pregnant or breast-feeding women; persons under guardianship,'}, 'identificationModule': {'nctId': 'NCT06976034', 'acronym': 'CERES-OTT', 'briefTitle': 'oCular Examination at Cell RESolution With Optical TransmissionTomography', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts"}, 'officialTitle': 'oCular Examination at Cell RESolution With Optical TransmissionTomography', 'orgStudyIdInfo': {'id': 'P24-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Ocular Disease', 'description': 'Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years', 'interventionNames': ['Device: Optical Transmission Tomography (OTT)', 'Device: Optical Coherence Tomography (OCT)', 'Device: Specular Microscopy (SM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteers', 'description': 'Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions', 'interventionNames': ['Device: Optical Transmission Tomography (OTT)', 'Device: Optical Coherence Tomography (OCT)', 'Device: Specular Microscopy (SM)']}], 'interventions': [{'name': 'Optical Transmission Tomography (OTT)', 'type': 'DEVICE', 'description': 'Multiple imaging sessions added by research using the systems described (OTT) will be carried out by two different operators at different positions during these sessions.', 'armGroupLabels': ['Healthy volunteers', 'Patients with Ocular Disease']}, {'name': 'Optical Coherence Tomography (OCT)', 'type': 'DEVICE', 'description': 'Multiple imaging sessions (OCT) already used in standard of care will be performed by two different operators at different positions during these sessions.', 'armGroupLabels': ['Healthy volunteers', 'Patients with Ocular Disease']}, {'name': 'Specular Microscopy (SM)', 'type': 'DEVICE', 'description': 'Multiple imaging sessions (SM) already used in standard of care will be performed by two different operators at different positions during these sessions.', 'armGroupLabels': ['Healthy volunteers', 'Patients with Ocular Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabil BROUK', 'role': 'CONTACT', 'email': 'nbrouk@15-20.fr', 'phone': '00 33 1 40 02 11 44'}, {'name': 'Nacim BOUHERAOUA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Nabil BROUK', 'role': 'CONTACT', 'email': 'nbrouk@15-20.fr', 'phone': '00 33 1 40 02 11 44'}], 'overallOfficials': [{'name': 'Nacim BOUHERAOUA, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}