Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT04128150
Status:
UNKNOWN
Last Update Posted:
2019-10-16
First Post:
2019-10-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Resolution Retina Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of retina diseases', 'timeFrame': 'From date of inclusion until the date of last documented progression , assessed up to 5 years', 'description': 'Increase the clinical experience of using the rtx1 camera in various conditions with retinal impact'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinitis Pigmentosa', 'Maculopathy, Age Related', 'Macular Dystrophy', 'Macular Edema', 'Retinal Degeneration', 'Diabetic Retinopathy', 'Occlusion Retinal Vein', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '35814763', 'type': 'DERIVED', 'citation': 'Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pathologies affecting photoreceptors and the retinal vessels', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons over 12 years of age, of both sexes, presenting with retinal pathologies.\n* Beneficiaries of the health insurance\n\nExclusion Criteria:\n\n* Any abnormality preventing good quality OA imaging on both eyes\n* Major under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT04128150', 'acronym': 'IHR', 'briefTitle': 'High Resolution Retina Imaging', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts"}, 'officialTitle': 'High Resolution Retina Imaging', 'orgStudyIdInfo': {'id': '2017-A03223-50'}, 'secondaryIdInfos': [{'id': '2017-A03223-50', 'type': 'OTHER', 'domain': 'N° IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie Krivosic, PH', 'role': 'CONTACT'}], 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel PAQUES, PU-PH', 'role': 'CONTACT', 'email': 'mpaques@15-20.fr', 'phone': '01 40 02 14 15'}], 'facility': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antonio Gallo, PH', 'role': 'CONTACT'}], 'facility': 'Hôpital Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Tania RILCY', 'role': 'CONTACT', 'email': 'trilcy@15-20.fr', 'phone': '+33 140021126'}, {'name': 'Hayet SERHANE', 'role': 'CONTACT', 'email': 'hserhane@15-20.fr', 'phone': '+33 140021144'}], 'overallOfficials': [{'name': 'Michel PAQUES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vints"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}