Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-06 @ 10:21 AM
Study NCT ID:
NCT01255293
Status:
COMPLETED
Last Update Posted:
2013-06-14
First Post:
2010-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D018630', 'term': 'Vitreoretinopathy, Proliferative'}, {'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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-13', 'studyFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal redetachment rate', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'Best-corrected visual acuity', 'timeFrame': '6 and 12 months'}, {'measure': 'Silicone oil emulsification rate', 'timeFrame': 'Monthly', 'description': 'Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retinal detachment', 'Proliferative vitreoretinopathy', 'Diabetic retinopathy', 'Vitrectomy', 'Silicone oil'], 'conditions': ['Retinal Detachment', 'Vitrectomy', 'Proliferative Vitreoretinopathy', 'Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '32408387', 'type': 'DERIVED', 'citation': 'Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.', 'detailedDescription': 'As part of retinal detachment surgery, the eye is typically filled with a gas bubble or silicone oil bubble. This bubble acts like a balloon inside the eye and helps to keep the retina pushed back against the eye wall so it can heal in its proper place. Gas bubbles spontaneously dissolve over a few weeks whereas silicone oil remains in the eye until removed with another surgery. When retinal detachments are associated with significant scar tissue on the retinal surface, silicone oil is often used since it can remain filling the eyeball for as long as necessary to help the retina to heal properly in place. Currently, two different types of silicone oil (1000 centistoke and 5000 centistoke) are commercially available and have been approved for use in the eye by the Food and Drug Administration. The goal of the study is to compare the outcomes using these two different types of silicone oil.\n\nThe retinal detachment will be repaired in a standard fashion. There will be no difference between the way retinal detachments are repaired in this study compared to those not in this study. Patients will be randomly assigned (like a flip of a coin) to receive one of the types of silicone oil. Both types of oil have very similar characteristics. The primary difference is that one type is thicker (more viscous) than the other, analogous to honey in comparison with maple syrup.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of rhegmatogenous retinal detachment or tractional retinal detachment due to grade C or worse proliferative vitreoretinopathy or proliferative diabetic retinopathy.\n* Judgment by the investigator that silicone oil tamponade is surgically indicated for appropriate repair of the complex retinal detachment.\n* Visual acuity of light perception or better.\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study.\n\nExclusion Criteria:\n\n* Inability to re-attach the retina at the time of surgery.\n* Prior trabeculectomy or tube shunt surgery.\n* Corneal opacity which limits visualization of the trabecular meshwork.'}, 'identificationModule': {'nctId': 'NCT01255293', 'briefTitle': 'Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments', 'organization': {'class': 'OTHER', 'fullName': 'Mid Atlantic Retina'}, 'officialTitle': 'A Prospective, Randomized Study Comparing 1000 Centistoke and 5000 Centistoke Silicone Oil Tamponade for Repair of Proliferative Vitreoretinopathy Retinal Detachments and Diabetic Tractional Retinal Detachments', 'orgStudyIdInfo': {'id': 'MAR-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1000 centistoke silicone oil', 'interventionNames': ['Procedure: 1000 centistoke silicone oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5000 centistoke silicone oil', 'interventionNames': ['Procedure: 5000 centistoke silicone oil']}], 'interventions': [{'name': '1000 centistoke silicone oil', 'type': 'PROCEDURE', 'description': 'Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 1000 centistoke silicone oil.', 'armGroupLabels': ['1000 centistoke silicone oil']}, {'name': '5000 centistoke silicone oil', 'type': 'PROCEDURE', 'description': 'Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 5000 centistoke silicone oil', 'armGroupLabels': ['5000 centistoke silicone oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jason Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mid Atlantic Retina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mid Atlantic Retina', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jason Hsu', 'oldOrganization': 'Mid Atlantic Retina'}}}}