Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:24 AM
Study NCT ID:
NCT07338461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Resolution Imaging OCT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061848', 'term': 'Optical Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 97}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cSLO Image quality grading', 'timeFrame': '6 months after image acquisition', 'description': 'Good: Good focus, even illumination, optimal exposure Average: The image is of sub-optimal quality, where there are issues with focus, illumination, or exposure, but the image still allows assessment of clinically relevant content Poor: Clinically relevant features are not visible, images are not clinically useful'}, {'measure': 'Visability of key anatomical structures', 'timeFrame': '6 months after image acquisition', 'description': 'Visibility of\n\nOCT image:\n\n1. Difference in reflectivity between the outer retino-choroidal complex and vitreous\n2. The vitreo-retinal interface\n3. Difference in reflectivity between retinal nerve fiber layer and vitreous\n4. Difference in reflectivity between plexiform layer and vitreous\n5. Multiple layers within the outer retino-choroidal complex\n6. The ganglion cell layer\n7. Difference in reflectivity between outer nuclear layer and vitreous\n8. External limiting membrane\n9. Choroidal/scleral interface\n\nOCTA image:\n\n1. Foveal avascular zone\n2. Large vessels: 1st order vasculature, if applicable\n3. Medium vessels: 2nd and 3rd order vasculature\n4. Small vessels: between 3rd order vasculature and end capillaries\n5. End capillaries'}], 'secondaryOutcomes': [{'measure': 'Safety Monitoring', 'timeFrame': 'from enrollment to study completion (expected 1 year after initiation)', 'description': 'Observation of possible adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Eyes', 'Age Related Macular Degeneration', 'Diabetic Retinopathy', 'Eyes With Retinal Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.\n\nParticipants will be imaged with different imaging modalities and scan protocols on all study devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Able and willing to undergo the test procedures, give consent, and to follow instructions.\n\nSigned informed consent Age ≥ 18 years\n\n* Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20/40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)\n* Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular\n* Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator\n* Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator\n\nExclusion Criteria:\n\n* Subjects unable to read or write\n* Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging\n* Subjects who cannot tolerate the imaging procedures\n* History of photosensitive epilepsy\n* Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.'}, 'identificationModule': {'nctId': 'NCT07338461', 'briefTitle': 'High Resolution Imaging OCT Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Engineering GmbH'}, 'officialTitle': 'High Resolution Imaging OCT Pilot Study', 'orgStudyIdInfo': {'id': 'R-2025-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational device R1', 'description': 'Imaging with the investigational device R1', 'interventionNames': ['Device: Autofluorescence Imaging', 'Device: Infrared reflectance imaging', 'Device: OCT imaging', 'Device: OCTA imaging']}, {'type': 'EXPERIMENTAL', 'label': 'HighRes OCT', 'description': 'Imaging with the investigational device HighRes OCT', 'interventionNames': ['Device: Autofluorescence Imaging', 'Device: Infrared reflectance imaging', 'Device: OCT imaging', 'Device: OCTA imaging']}, {'type': 'OTHER', 'label': 'SPECTRALIS', 'description': 'Imaging with the approved device SPECTRALIS', 'interventionNames': ['Device: Autofluorescence Imaging', 'Device: Infrared reflectance imaging', 'Device: OCT imaging', 'Device: OCTA imaging']}], 'interventions': [{'name': 'Autofluorescence Imaging', 'type': 'DEVICE', 'description': 'Autofluorescence imaging with blue and green light and, multicolor imaging', 'armGroupLabels': ['HighRes OCT', 'Investigational device R1', 'SPECTRALIS']}, {'name': 'Infrared reflectance imaging', 'type': 'DEVICE', 'description': 'Infrared reflectance imaging, 30° Field of View', 'armGroupLabels': ['HighRes OCT', 'Investigational device R1', 'SPECTRALIS']}, {'name': 'OCT imaging', 'type': 'DEVICE', 'description': 'OCT Imaging Volume and Line Scans', 'armGroupLabels': ['HighRes OCT', 'Investigational device R1', 'SPECTRALIS']}, {'name': 'OCTA imaging', 'type': 'DEVICE', 'description': 'OCT Angiography, volume and SCOUT scan', 'armGroupLabels': ['HighRes OCT', 'Investigational device R1', 'SPECTRALIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Mariano Cozzi, MD', 'role': 'CONTACT', 'email': 'Mariano.cozzi@unimi.it', 'phone': '+39 0239042666'}], 'facility': 'Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Aike T. Schweda, PhD', 'role': 'CONTACT', 'email': 'Aike.Schweda@HeidelbergEngineering.com', 'phone': '+49 62216463387'}, {'name': 'Clinical Trials', 'role': 'CONTACT', 'email': 'clinical.trials@HeidelbergEngineering.com'}], 'overallOfficials': [{'name': 'Mariano Cozzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Engineering GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}