Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT01809704
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2013-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of New OCT System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2013-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2013-03-08', 'studyFirstSubmitQcDate': '2013-03-08', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal Thickness', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subjects Presenting With Normal or With Ocular Pathology']}, 'descriptionModule': {'briefSummary': 'To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects that are Normal, or shows signs of Glaucoma or Retinal Ocular Pathology.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Normal Group\n\n1. Subjects 18 years of age or older on the date of informed consent\n2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent\n3. Subjects presenting at the site with normal eyes (eyes without pathology)\n4. IOP ≤ 21 mmHg bilaterally\n5. BCVA 20/40 or better bilaterally\n6. Both eyes must be free of eye disease\n\nExclusion Criteria for Normal Group\n\n1. Subjects unable to tolerate ophthalmic imaging\n2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images\n3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \\< 1%\n4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \\> 33% or false positives \\> 25%, or false negatives \\> 25%\n5. Presence of any ocular pathology except for cataract\n6. Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning\n7. Narrow angle\n8. History of leukemia, dementia or multiple sclerosis\n9. Concomitant use of hydroxychloroquine and chloroquine\n\nInclusion Criteria for Glaucoma Group\n\n1. Subjects 18 years of age or older on the date of informed consent\n2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent\n3. Subjects presenting at the site with glaucoma\n4. BCVA 20/40 or better in the study eye\n5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \\< 1% in the study eye\n\nExclusion Criteria for Glaucoma Group\n\n1. Subjects unable to tolerate ophthalmic imaging\n2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images\n3. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses \\> 33% or false positives \\> 25%, or false negatives \\> 25% in the study eye\n4. Presence of any ocular pathology except glaucoma in the study eye\n5. Previous ocular surgery or laser treatment other than uncomplicated procedures performed within six months prior to study scanning in the study eye\n6. History of leukemia, dementia or multiple sclerosis\n7. Concomitant use of hydroxychloroquine and chloroquine\n\nInclusion Criteria for Retina Disease Group\n\n1. Subjects 18 years of age or older on the date of informed consent\n2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent\n3. Subjects presenting at the site with retinal disease\n4. IOP \\<= 21 mmHg in the study eye\n5. BCVA 20/400 or better in the study eye\n6. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others\n\nExclusion Criteria for Retinal Disease Group\n\n1. Subjects unable to tolerate ophthalmic imaging\n2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images\n3. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye\n4. Previous ocular surgery or laser treatment other than uncomplicated procedures performed within six months prior to study scanning in the study eye\n5. Narrow angle in the study eye\n6. History of leukemia, dementia or multiple sclerosis\n7. Concomitant use of hydroxychloroquine and chloroquine"}, 'identificationModule': {'nctId': 'NCT01809704', 'briefTitle': 'Clinical Validation of New OCT System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'Topcon DRI OCT-1 Optical Coherence Tomography System for the Acquisition of Retinal Thickness Measurements and Ocular Images of the Posterior Chamber: Agreement and Precision Study', 'orgStudyIdInfo': {'id': 'DC-03267'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal', 'description': 'Normal results from clinical exam and free of ocular pathology.'}, {'label': 'Glaucoma', 'description': 'Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.'}, {'label': 'Retina', 'description': 'Clinical exam results consistent with retina pathology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Hamilton Glaucoma Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '11425', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Murray Fingeret', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Vitreous Retina Macula Consultants of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael Sinai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Clinical Marketing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}