Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT03672656
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pattern Laser Versus Conventional Laser in Diabetic Retinopathy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2014-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages', 'timeFrame': '1 year', 'description': 'progression of diabetic retinopathy after pattern PASCAL laser versus conventional laser. Each item is scored by calculating of microaneurisms and intraretinal hemorrhages'}, {'measure': 'Pain assessed by NRS', 'timeFrame': '1 day', 'description': 'painfulness of pattern PASCAL laser versus conventional laser Each item is scored 0-10 (0 - no pain, 10 - pain as bad as can be)'}], 'secondaryOutcomes': [{'measure': 'Satisfaction assessed by the VAS', 'timeFrame': '1 day', 'description': 'subjective satisfaction of the patient on dog 0 to 4 0 - not satisfied, 4 - very satisfied after pattern PASCAL laser versus conventional laser'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic retinopathy', 'patterns', 'low time of impulse', 'Pascal'], 'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '31310626', 'type': 'DERIVED', 'citation': 'Nemcansky J, Stepanov A, Nemcanska S, Masek P, Langrova H, Studnicka J. Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness. PLoS One. 2019 Jul 16;14(7):e0219282. doi: 10.1371/journal.pone.0219282. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy.\n\nMethods: The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (SSP) (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method (MSM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic retinopathy\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT03672656', 'briefTitle': 'Pattern Laser Versus Conventional Laser in Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness', 'orgStudyIdInfo': {'id': 'FNO-OCNI-Pascal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pattern scanning laser system Pascal', 'interventionNames': ['Device: lasercoagulation by Pascal system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional laser', 'interventionNames': ['Device: conventional laser']}], 'interventions': [{'name': 'lasercoagulation by Pascal system', 'type': 'DEVICE', 'description': 'pattern scanning laser system Pascal given in a single-session', 'armGroupLabels': ['pattern scanning laser system Pascal']}, {'name': 'conventional laser', 'type': 'DEVICE', 'description': 'conventional laser multiple-session treatment', 'armGroupLabels': ['conventional laser']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}