Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-03 @ 10:03 AM
Study NCT ID:
NCT05643157
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2022-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structure and Function of Retinal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers', 'timeFrame': '2 years', 'description': 'Images of the photoreceptor and RPE cell layers taken with clinical instruments and the AO-OCT will be compared.'}, {'measure': 'RPE cell morphology changes', 'timeFrame': '2 years', 'description': 'Images will be used to determine the changes in RPE cell morphology in regions of healthy and diseased retina (in subjects with retinal disease).'}, {'measure': 'Cone Photoreceptor Dysfunction', 'timeFrame': '2 years', 'description': 'Images will be used to determine changes in cone photoreceptor dysfunction and death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['retinal toxicity'], 'conditions': ['Retinal Toxicity']}, 'descriptionModule': {'briefSummary': "Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to image the human retina in finer detail.", 'detailedDescription': "This research study will (1) test the ability of a new electronic camera developed in Dr. Miller's laboratory to collect extremely sharp volumetric images of the retina in human subjects, and (2) use the camera for addressing fundamental questions about how disease progresses in the eye. This new camera integrates cutting-edge technologies in adaptive optics (AO) and optical coherence tomography (OCT) that enable the camera to capture sharp images. However, many aspects of the camera are already employed in clinical instruments used routinely by eyecare practitioners worldwide. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe and quantify finer detail in the retina than current clinical cameras, and (2) whether this finer detail is useful for understanding the progression of disease in the eye.\n\nTo address the second objective, the study will look at two subgroups of retinal disease. The first is age-related macular degeneration (AMD), a leading cause of blindness in the developed world. Because this disease is difficult to study directly as it takes years to progress, we will study it indirectly using subjects with a form of retinal toxicity that exhibits a retinal phenotype similar to that of AMD but progresses on a much faster time scale. The second disease subgroup is inherited retinal degeneration that affects as many as 1 in every 2,000 people worldwide. For this subgroup, the researchers will test the exquisite sensitivity of the AO-OCT imaging system to detect minute changes in disease progression over short periods of time covering weeks and months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retinal disease of either inherited retinal degeneration or retinal toxicity\n\nExclusion Criteria:\n\n* Ocular media opacities\n* High refractive error\n* Pupil dilation imposes a risk to ocular health'}, 'identificationModule': {'nctId': 'NCT05643157', 'briefTitle': 'Structure and Function of Retinal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Structure and Function of Retinal Disease', 'orgStudyIdInfo': {'id': '18287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Retinal Disease', 'description': 'Subjects with either retinal toxicity or inherited retinal degeneration will undergo multimodal clinical imaging and Adaptive Optics Optical Coherence Tomography (AO-OCT) imaging at each study visit to document regions of disease and healthy retina over time.', 'interventionNames': ['Device: Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging']}], 'interventions': [{'name': 'Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging', 'type': 'DEVICE', 'description': "AO-OCT used in this study is an investigational OCT imaging system. . In this instrument, ocular aberration sensing and correction is achieved with a Shack-Hartmann wavefront sensor (SHWS) and deformable mirror, respectively. A pupil camera and fixation target are used to position the participant's head and eye for scanning a particular retinal region within 15 degrees of the fovea. Data collected generally includes AO-OCT volume videos and SHWS measurements of ocular aberrations.", 'armGroupLabels': ['Retinal Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristen Bowles Johnson, O.D.,Ph.D.', 'role': 'CONTACT', 'email': 'kbowlesj@iu.edu', 'phone': '812-855-8991'}, {'name': 'Kristen Bowles Johnson, O.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Don Miller, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University School of Optometry', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'centralContacts': [{'name': 'Kristen Bowles Johnson, O.D.,Ph.D.', 'role': 'CONTACT', 'email': 'kbowlesj@iu.edu', 'phone': '812-855-8991'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Doctoral Researcher', 'investigatorFullName': 'Kristen Bowles Johnson', 'investigatorAffiliation': 'Indiana University'}}}}