Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-29 @ 9:19 AM
Study NCT ID:
NCT04285151
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2020-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-23', 'studyFirstSubmitDate': '2020-02-23', 'studyFirstSubmitQcDate': '2020-02-23', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity improvement', 'timeFrame': '1 week', 'description': 'Testing VA after YAG laser'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has been used to evacuate the premacular hemorrhage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes with premacular subhyaloid hemorrhage of more than 3 disc diameters, involving the fovea.\n* Eyes with proliferative diabetic retinopathy\n\nExclusion Criteria:\n\n* Dense media opacity (corneal/cataract)\n* Patients with bleeding tendency or on anti-coagulant drugs'}, 'identificationModule': {'nctId': 'NCT04285151', 'briefTitle': 'Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Evaluation of Nd:YAG Laser Hyaloidotomy for Management of Premacular Subhyaloid Hemorrhage in Eyes With Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'TUOR002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nd:YAG laser Hyaloidotomy', 'type': 'PROCEDURE', 'description': 'Using the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Sharif Yousef El Emam', 'investigatorAffiliation': 'Tanta University'}}}}