Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02036632
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Patch Therapy for Central Serous Retinopathy (CSR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR', 'timeFrame': '24 hours', 'description': 'This study is a prospective control trial that will compare 24-hour eye patch therapy with the current standard of care in patients with central serous retinopathy (CSR).'}, {'measure': 'Change in multi-focal ERG response', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'macular thickness', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Central Serous Retinopathy (CSR)']}, 'descriptionModule': {'briefSummary': 'First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years of age and older\n* Both males and females\n* Patients diagnosed with active central serous retinopathy\n* Patients who are willing to use an eye patch in the affected eye for 24 hours\n* Patients who are able to make the follow up appointments as required by the study\n\nExclusion Criteria:\n\n* Individuals under 18 years of age\n* Patients with vision less than 20/40 in the unaffected eye.\n* Patients who are not able to undergo mfERG testing in a realiable manner.'}, 'identificationModule': {'nctId': 'NCT02036632', 'briefTitle': 'Eye Patch Therapy for Central Serous Retinopathy (CSR)', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy', 'orgStudyIdInfo': {'id': '201211016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Eye Patching', 'description': 'Intervention', 'interventionNames': ['Device: Eye Patching']}], 'interventions': [{'name': 'Eye Patching', 'type': 'DEVICE', 'armGroupLabels': ['Eye Patching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Universtiy School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Gregory P Van Stavern, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}