Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 7:54 AM
Study NCT ID:
NCT01610804
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2012-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choroidal Thickness Measurements During Central Serous Chorioretinopathy (CSCR) Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-06-01', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Choroidal Thickness']}, 'referencesModule': {'references': [{'pmid': '19898183', 'type': 'BACKGROUND', 'citation': 'Imamura Y, Fujiwara T, Margolis R, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina. 2009 Nov-Dec;29(10):1469-73. doi: 10.1097/IAE.0b013e3181be0a83.'}, {'pmid': '19232559', 'type': 'BACKGROUND', 'citation': 'Margolis R, Spaide RF. A pilot study of enhanced depth imaging optical coherence tomography of the choroid in normal eyes. Am J Ophthalmol. 2009 May;147(5):811-5. doi: 10.1016/j.ajo.2008.12.008. Epub 2009 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine changes in choroidal thickness in patients with Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).\n\nStudy hypothesis: Since exudative changes in the choroid seem to constitute the primary pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present and be visible using EDI-OCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with reduction of vision due to Central Serous Chorioretinopathy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with initial diagnosis of CSCR and no treatment so far\n\nExclusion Criteria:\n\n* Therapy (drugs/laser) due to CSCR'}, 'identificationModule': {'nctId': 'NCT01610804', 'briefTitle': 'Choroidal Thickness Measurements During Central Serous Chorioretinopathy (CSCR) Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Regensburg'}, 'officialTitle': 'Choroidal Thickness Measurements During CSCR Treatment Applying EDI-OCT Technology', 'orgStudyIdInfo': {'id': 'CSCR2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CSCR-Patients', 'description': 'Patients suffering from Central Serous Chorioretinopathy'}, {'label': 'Healthy Subjects', 'description': 'Healthy subjects with (assumed) normal choroidal thickness'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'University Hospital Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Maria A Gamulescu, PD Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Caroline Brandl', 'investigatorAffiliation': 'University Hospital Regensburg'}}}}