Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-04 @ 12:02 PM
Study NCT ID:
NCT01806402
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2013-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of OCT Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2013-03-05', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retina thickness', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Assess Eye Measurements in Patients Having Retina Pathology or Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.', 'detailedDescription': 'The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients using OCT technology. There will be a series of measurements acquired from one eye on at least 2 different OCT devices. All testing will be completed in one visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will have retina pathology or glaucoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criterea:\n\n* At least 18 years of age\n* Able and willing to provide consent\n* Willing to complete the required examinations and visits\n* Best corrected visual acuity equal or better than 20/100\n* Retina subject must have clinical diagnosis of retinal pathology\n* Glaucoma subjects must have clinical diagnosis of glaucoma\n\nExclusion Criteria:\n\n* Unable to complete the required examinations and visits\n* Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment\n* Confounding pathology requiring surgical treatment or medical intervention'}, 'identificationModule': {'nctId': 'NCT01806402', 'briefTitle': 'Evaluation of OCT Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optovue'}, 'officialTitle': 'Evaluation of the Precision and Accuracy of OCT Measurements in Retinal and Glaucoma Patients', 'orgStudyIdInfo': {'id': '20130104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retina', 'description': 'Having clinical diagnosis of retina pathology'}, {'label': 'Glaucoma', 'description': 'Having clinical diagnosis of glaucoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94015', 'city': 'Daly City', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Eye Specialists', 'geoPoint': {'lat': 37.70577, 'lon': -122.46192}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Retinal Medical Group', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optovue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}