Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03969303
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2018-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients', 'timeFrame': 'less than an hour', 'description': 'To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.'}], 'secondaryOutcomes': [{'measure': 'Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients', 'timeFrame': 'less then an hour', 'description': 'To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DR patients. OCT images from the central 10 degrees of the macula in DR patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.'}, {'measure': 'Patient experience using the NOTAL-OCT v.2.5 device', 'timeFrame': 'less than an hour', 'description': 'Patients will complete a questionnaire with 13 statements or questions regarding the usability of the NOTAL-OCT v.2.5 device. For the first 10 statements, patients are asked to specify a level of agreement to the statement. The scale is named "Level of Agreement" and ranges from 1 = strongly agree, to 5 = strongly disagree. A patient\'s indicating a value of 1 is considered to be a better outcome. The remaining 3 questions are free-form.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AMD - Age-Related Macular Degeneration', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nTo evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.\n\nSecondary objectives:\n\n1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients.\n2. To evaluate patient experience when self-operating the Notal-OCT V2.5.', 'detailedDescription': 'To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.\n\nTo evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.\n\nPatients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AMD and DME patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability and willingness to give informed consent (IC)\n* 18 years of age or older\n* Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record\n* Ability to undergo OCT (optical coherence tomography) testing\n* Visual acuity of 20/400 Snellen (6/120) or better in the study eye\n\nExclusion Criteria:\n\n\\- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study."}, 'identificationModule': {'nctId': 'NCT03969303', 'briefTitle': 'NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Notal Vision Inc.'}, 'officialTitle': 'Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol', 'orgStudyIdInfo': {'id': 'C2018.008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NOTAL OCT v.2.5 and Commercial OCT on AMD Patients', 'description': 'OCT Images will be obtained in the central 10 degrees of the macula in AMD patients using the NOTAL OCT v.2.5 device and a Commercial device (Zeiss Cirrus/Heidelberg SPECTRALIS).', 'interventionNames': ['Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)']}], 'interventions': [{'name': 'Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)', 'type': 'DEVICE', 'description': 'OCT SCAN', 'armGroupLabels': ['NOTAL OCT v.2.5 and Commercial OCT on AMD Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Retina Group, PA', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Michael Elman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Notal Vision Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elman Retina Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}