Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-02 @ 6:20 AM
Study NCT ID:
NCT07020793
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Subthreshold Laser Therapy for Chronic Central Serous Chorioretinopathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in central foveal thickness', 'timeFrame': '3 months', 'description': 'to evaluate changen in Central foveal tickness (CFT), assessed on OCT images by manually placing calipers between the internal limiting membrane and the outer boundary of the retinal pigment epithelium, before and after treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['the Presence of Subretinal Fluid (SRF)']}, 'descriptionModule': {'briefSummary': 'Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction. This study evaluates the efficacy and safety of green subthreshold laser therapy using Norlase µSec Technology as a novel, tissue-sparing approach for treating chronic CSCR. By targeting RPE repair without inducing visible retinal damage, this technique aims to resolve subretinal fluid, restore retinal architecture, and improve visual function. This is the first study to report clinical outcomes with this specific laser platform in chronic CSCR management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes adult patients diagnosed with chronic Central Serous Chorioretinopathy (CSCR), defined by the presence of subretinal fluid (SRF) persisting for more than 4 months, as confirmed by optical coherence tomography (OCT)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubretinal fluid for more than three months, confirmed by multimodal imaging, diagnosis of chronic CSC in at least one eye.\n\nExclusion Criteria:\n\nany evidence of choroidal neovascularization on multimodal imaging, as well as a history of previous photodynamic therapy (PDT) or focal laser treatment for CSC, prior diagnosis of ocular hypertension, glaucoma, and optic nerve disorders, presence of active retinal conditions such as vitreomacular traction, epiretinal membrane, diabetic retinopathy, or retinal vein occlusion, lens opacities that could interfere with retinal imaging or compromise visual acuity'}, 'identificationModule': {'nctId': 'NCT07020793', 'briefTitle': 'Green Subthreshold Laser Therapy for Chronic Central Serous Chorioretinopathy.', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Efficacy of Green Subthreshold Laser Therapy in the Treatment of Chronic Central Serous Chorioretinopathy', 'orgStudyIdInfo': {'id': '05809855 Federico II'}}, 'armsInterventionsModule': {'interventions': [{'name': 'green subthreshold laser therapy', 'type': 'PROCEDURE', 'description': 'The intervention consists of green subthreshold laser therapy delivered using the Norlase µSec™ Technology, a novel microsecond-pulsed laser platform specifically designed for retinal treatments.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Italy', 'country': 'Italy', 'facility': 'university of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PHD', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}