Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02406157
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-29', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Best Corrected Visual Acuity(BCVA)', 'timeFrame': '1 year', 'description': 'Best Corrected Visual Acuity will be measured by standard Early Treatment Diabetic Retinopathy Study (ETDRS) protocol'}], 'secondaryOutcomes': [{'measure': 'Change in 10°retinal sensitivity', 'timeFrame': '1 year', 'description': 'Retinal sensitivity will be measured by microperimetry'}, {'measure': 'Change of fundus autofluorescence', 'timeFrame': '1 year', 'description': 'Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment'}, {'measure': 'Change of Central Retinal Thickness(CRT)', 'timeFrame': '1 year', 'description': 'Central Retinal Thickness will be performed by optical coherence tomography(OCT)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic macular edema', 'micropulse', 'laser', 'subthreshold'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '21345996', 'type': 'BACKGROUND', 'citation': 'Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy and safety of 577nm micropulse laser photocoagulation for diabetic macular edema compared with 532 subthreshold laser photocoagulation.', 'detailedDescription': '1. To evaluate the efficacy of 577nm micropulse laser photocoagulation with grid/focal treatment for diabetic macular edema.\n2. To investigate influence of 577nm micropulse laser photocoagulation on structure and function of macula compared with 532nm subthreshold laser photocoagulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>18 years\n* Patients with diabetes mellitus type 2\n* Diagnosed as diabetic retinopathy with Clinical Significant Macular Edema\n* Central retinal thickness(CRT) of more than 250μm as measured by optical coherence tomography (OCT)\n* ETDRS visual acuity \\>19 letters (Snellen equivalent of 20/400 or better)\n* No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months\n* Blood glucose was controlled steadily(HbA1c≤10%)\n\nExclusion Criteria:\n\n* Taking part in other clinical trial within 3 months\n* Planning panretinal photocoagulation(PRP) within 3 months\n* Performed cataract surgery in the last 3 months\n* Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)\n* Accompanied with severe opacity of refractive media that maybe impact therapy and observation\n* Accompanied with nystagmus\n* Accompanied with some history that maybe interfere with result or increase the risk of patients'}, 'identificationModule': {'nctId': 'NCT02406157', 'briefTitle': '577nm Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Pure Yellow (577nm) Micropulse Laser Versus 532nm Subthreshold Laser Photocoagulation for Diabetic Macular Edema:A Prospective, Randomized, Paralleled Clinical Trial', 'orgStudyIdInfo': {'id': 'ZOC-MPLD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '577-MPL', 'description': '577nm micropulse laser photocoagulation(577MPL) treatment to the macular area of retinal thickening with a focal or grid pattern', 'interventionNames': ['Device: 577-MPL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '532-SLP', 'description': '532nm subthreshold laser photocoagulation(532-SLP) treatment to the macular area of retinal thickening with a focal or grid pattern', 'interventionNames': ['Device: 532-SLP']}], 'interventions': [{'name': '577-MPL', 'type': 'DEVICE', 'otherNames': ['577nm micropulse laser photocoagulation treatment'], 'description': 'Device for 577nm micropulse treatment of the diabetic macular edema with the following parameters:100 microns spot size,5% duty cycle of 0.2 seconds,power is tested on micropulse mode and then reduce power to 50% of visible', 'armGroupLabels': ['577-MPL']}, {'name': '532-SLP', 'type': 'DEVICE', 'otherNames': ['532nm subthreshold laser photocoagulation treatment'], 'description': "Device for 532nm subthreshold treatment of the diabetic macular edema, by decomposing a subthreshold short pulse, with 10 milliseconds, 100 microns, and power(100-1000mW) adjusted according to patient's diopter transparency and pigmentation", 'armGroupLabels': ['532-SLP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Chenjin Jin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Lijun Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jin Chen-jin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}