Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-04 @ 1:06 PM
Study NCT ID:
NCT02042703
Status:
TERMINATED
Last Update Posted:
2015-10-21
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Lens Deposits in Exfoliation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017889', 'term': 'Exfoliation Syndrome'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unanticipated slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of exfoliation deposits on the lens as measured by AS-OCT', 'timeFrame': '20 min (length of imaging)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Exfoliation Syndrome', 'Primary Open Angle Glaucoma', 'Cataracts']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from Glaucoma and Comparehensive clinics at the duke Eye Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts\n\nExclusion Criteria:\n\n* Unable to provide or sign consent\n* Pseudophakia\n* Other prior intraocular surgery\n* Other eye diseases other than refractive error'}, 'identificationModule': {'nctId': 'NCT02042703', 'briefTitle': 'Imaging Lens Deposits in Exfoliation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT', 'orgStudyIdInfo': {'id': 'Pro00050919'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'exfoliation syndrome', 'description': 'patients with exfoliation syndrome', 'interventionNames': ['Device: anterior segment OCT']}, {'label': 'POAG', 'description': 'patients with primary open angle glaucoma (POAG)', 'interventionNames': ['Device: anterior segment OCT']}, {'label': 'cataracts', 'description': 'patients with cataracts', 'interventionNames': ['Device: anterior segment OCT']}], 'interventions': [{'name': 'anterior segment OCT', 'type': 'DEVICE', 'armGroupLabels': ['POAG', 'cataracts', 'exfoliation syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}