Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00802269
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2008-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (NRS-11 scale)', 'timeFrame': 'Immediately post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proliferative diabetic retinopathy', 'Laser photocoagulation', 'Pain'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older, that signed informed consent\n* Proliferative diabetic retinopathy with indication for panretinal photocoagulation\n\nExclusion Criteria:\n\n* Previous retinal photocoagulation\n* Previous ocular surgical procedures\n* Ocular media opacities\n* History of trigeminal neuralgia\n* Chronic ocular pain\n* Depression under conductual or medical treatment'}, 'identificationModule': {'nctId': 'NCT00802269', 'briefTitle': 'Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.', 'orgStudyIdInfo': {'id': 'APEC-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Fluence Parameters', 'description': 'Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)', 'interventionNames': ['Procedure: Retinal laser photocoagulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional parameters', 'description': 'Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)', 'interventionNames': ['Procedure: Retinal laser photocoagulation']}], 'interventions': [{'name': 'Retinal laser photocoagulation', 'type': 'PROCEDURE', 'otherNames': ['Alcon Eyelite 532 (doubled frequency Nd:Yag)'], 'description': 'Retinal laser photocoagulation using a 532 nm laser', 'armGroupLabels': ['Reduced Fluence Parameters', 'Traditional parameters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociacion para Evitar la Ceguera en Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Oscar Alvarez-Verduzco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}