Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-29 @ 11:52 AM
Study NCT ID:
NCT01033968
Status:
COMPLETED
Last Update Posted:
2010-05-20
First Post:
2009-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Perception at Laser Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-19', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Although the treatment of peripheral retinal degenerations with infrared laser to be well tolerated by the majority of the patients, it is more painful than with green wavelength.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lasers', 'pain measurement', 'photocoagulation', 'retina'], 'conditions': ['Laser Therapy, Low-Level']}, 'referencesModule': {'references': [{'pmid': '20691418', 'type': 'DERIVED', 'citation': 'Lira RP, Nascimento MA, Arieta CE, de Carvalho KM, Silva VB. Pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths. Am J Ophthalmol. 2010 Nov;150(5):726-730.e1. doi: 10.1016/j.ajo.2010.05.027. Epub 2010 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.', 'detailedDescription': 'Purpose: To compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.\n\nMethods: Thirty patients (60 eyes) were enrolled in the study. Each patient had one eye treated with infrared laser (diode, 810nm) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm). The laser treatment was performed following a standardized protocol. Immediately after photocoagulation, the patient was asked to grading pain perception according an 11-point (i.e. 0-10) numerical rating scale (NRS) 2,3, accompanied by the instructions "Please rate your pain by indicating the number that best describes it". This NRS is represented as a straight line (10 cm in length). The numbers between 0 and 10 are spaced at regular intervals along the line, at either end of the line are two poles that are defined as the extreme limits of the response to be measure, with \'0\' meaning \'No pain\' and \'10\' meaning \'Pain as bad as you can imagine\'.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* horseshoe tears and dialyses, besides operculated holes and lattice degeneration in symptomatic patients (photopsias) or with history of retinal disease\n\nExclusion Criteria:\n\n* severe liver disease, pregnancy, patients on regular analgesics, previous laser photocoagulation, and age less than 18 years old.'}, 'identificationModule': {'nctId': 'NCT01033968', 'briefTitle': 'Pain Perception at Laser Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Pain Perception at Laser Treatment of Peripheral Retinal Degenerations With Green and Infrared Wavelengths', 'orgStudyIdInfo': {'id': 'Lira-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'retina photocoagulation', 'type': 'PROCEDURE', 'description': 'Each patient had one eye treated with infrared laser (diode, 810nm wavelength) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm wavelength'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Rodrigo Pessoa Cavalcanti Lira', 'oldOrganization': 'UNICAMP'}}}}