Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT01434095
Status:
COMPLETED
Last Update Posted:
2011-09-15
First Post:
2011-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-14', 'studyFirstSubmitDate': '2011-09-13', 'studyFirstSubmitQcDate': '2011-09-13', 'lastUpdatePostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'best corrected visual acuity', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'retinal sensitivity', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microperimetry', 'fixation point', 'retinal sensitivity', 'photodynamic therapy', 'chronic central serous chorioretinopathy'], 'conditions': ['Chronic Central Serous Chorioretinopathy']}, 'referencesModule': {'references': [{'pmid': '22818904', 'type': 'DERIVED', 'citation': 'Fujita K, Shinoda K, Imamura Y, Matsumoto CS, Mizutani Y, Mizota A, Yuzawa M. Correlation of integrity of cone outer segment tips line with retinal sensitivity after half-dose photodynamic therapy for chronic central serous chorioretinopathy. Am J Ophthalmol. 2012 Sep;154(3):579-85. doi: 10.1016/j.ajo.2012.03.043. Epub 2012 Jul 20.'}]}, 'descriptionModule': {'briefSummary': "A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy.\n\nThe researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. The researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.", 'detailedDescription': 'The best-corrected visual acuity (BCVA), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. The macular sensitivity and fixation stability were determined by MP-1 microperimetry (Nidek, Vigonza, Italy). The researchers analysed whether the BCVA and retinal sensitivity significantly improved or not. And if yes, the researchers were interested at which period after treatment the significant improvement was found. Also, the researchers investigated which improved first, BCVA or retinal sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images\n* a serous retinal detachment of at least 6 months duration.\n\nExclusion Criteria:\n\n* evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography'}, 'identificationModule': {'nctId': 'NCT01434095', 'briefTitle': 'Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Surugadai Nihon University Hospital'}, 'orgStudyIdInfo': {'id': '81004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'half-dose PDT(photodynamic therapy)', 'description': 'The study include single arm; treated group, and no control group was included.', 'interventionNames': ['Procedure: half-dose photodynamic therapy']}], 'interventions': [{'name': 'half-dose photodynamic therapy', 'type': 'PROCEDURE', 'description': 'photodynamic therapy (PDT) was performed using 3 mg/m2 body surface area of verteporfin (Visudyne, Novartis AG, Bülach, Switzerland) which is one-half the conventional dose of verteporfin. The verteporfin was infused over a 10 minute period followed by the delivery of 50 J/cm2 from a 689-nm laser system (Carl Zeiss, Dublin, CA) over an 83-second exposure time.', 'armGroupLabels': ['half-dose PDT(photodynamic therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101-8309', 'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Department of Ophthalmology, Surugadai Nihon University Hospital'}], 'overallOfficials': [{'name': 'Kyoko Fujita, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Surugadai Nihon University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Surugadai Nihon University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teikyo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Kyoko Fujita, MD, PhD', 'investigatorFullName': 'Kyoko Fujita', 'investigatorAffiliation': 'Surugadai Nihon University Hospital'}}}}