Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT03571659
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2018-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA', 'timeFrame': '3 months', 'description': 'Comparing the number of leaking microaneuyrms baseline to 6 weeks with 3 types of lasers (two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS continuous wave (CW) laser.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '29996798', 'type': 'DERIVED', 'citation': 'Chhablani J, Alshareef R, Kim DT, Narayanan R, Goud A, Mathai A. Comparison of different settings for yellow subthreshold laser treatment in diabetic macular edema. BMC Ophthalmol. 2018 Jul 11;18(1):168. doi: 10.1186/s12886-018-0841-z.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser', 'detailedDescription': 'Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group.\n\nFocal to Mas+ confluent burns to areas of diffuse leakage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Asian', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes with DME (center or non-center involving) with \\<350 microns central retinal thickness\n\nExclusion Criteria:\n\n* Subfoveal exudates, history of VR surgery, history of macular laser'}, 'identificationModule': {'nctId': 'NCT03571659', 'briefTitle': 'Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'L.V. Prasad Eye Institute'}, 'officialTitle': 'To Assess the Safety and Efficacy of Two Subthreshold Parameters (5% and 15% Duty Cycle (DC)) Compared to Standard ETDRS (Early Treatment of Diabetic Retinopathy Study) Continuous Wave (CW) Laser', 'orgStudyIdInfo': {'id': 'LVPEI-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'two subthreshold parameters', 'description': '5% and 15% duty cycle (DC)', 'interventionNames': ['Procedure: Laser']}, {'label': 'standard ETDRS', 'description': 'early treatment of diabetic retinopathy study', 'interventionNames': ['Procedure: Laser']}], 'interventions': [{'name': 'Laser', 'type': 'PROCEDURE', 'armGroupLabels': ['standard ETDRS', 'two subthreshold parameters']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'L.V. Prasad Eye Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Jay Chhablani', 'investigatorAffiliation': 'L.V. Prasad Eye Institute'}}}}