Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00403702
Status:
WITHDRAWN
Last Update Posted:
2024-06-03
First Post:
2006-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison High-density Silicone Oils in Retinal Detachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D018630', 'term': 'Vitreoretinopathy, Proliferative'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539721', 'term': 'oxane HD'}, {'id': 'C515608', 'term': 'densiron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2006-11-02', 'studyFirstSubmitQcDate': '2006-11-24', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity'}, {'measure': 'anatomical results'}], 'secondaryOutcomes': [{'measure': 'complication: hypotony,'}, {'measure': 'vitreous hemorrhage,'}, {'measure': 'inflammatory reaction,'}, {'measure': 'cataract,'}, {'measure': 'chronic hypotony,'}, {'measure': 'IOP elevated intraocular pressure,'}, {'measure': 'pseudohypopyon,'}, {'measure': 'fibrin,'}, {'measure': 'emulsification droplets in the anterior chamber'}]}, 'conditionsModule': {'keywords': ['Retinal detachment', 'proliferative vitreoretinopathy', 'heavier-than-water internal tamponades'], 'conditions': ['Retinal Detachment']}, 'referencesModule': {'references': [{'pmid': '16205937', 'type': 'BACKGROUND', 'citation': 'Sandner D, Engelmann K. First experiences with high-density silicone oil (Densiron) as an intraocular tamponade in complex retinal detachment. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):609-19. doi: 10.1007/s00417-005-0110-8. Epub 2005 Oct 5.'}, {'pmid': '15029505', 'type': 'BACKGROUND', 'citation': 'Theelen T, Tilanus MA, Klevering BJ. Intraocular inflammation following endotamponade with high-density silicone oil. Graefes Arch Clin Exp Ophthalmol. 2004 Jul;242(7):617-20. doi: 10.1007/s00417-004-0898-7. Epub 2004 Mar 17.'}, {'pmid': '1483133', 'type': 'BACKGROUND', 'citation': 'Nicolai U, Eckardt C, Kohlhoff M, Wottge HU. Biocompatibility of silicone oil and high-density liquids. An immunologic study. Ger J Ophthalmol. 1992;1(3-4):180-7.'}, {'pmid': '3737116', 'type': 'BACKGROUND', 'citation': 'Mester U, Rothe R, Zubcov A. Experimental studies with a high-density silicone oil for giant retinal tear. Ophthalmic Res. 1986;18(2):81-6. doi: 10.1159/000265419.'}, {'pmid': '16625267', 'type': 'BACKGROUND', 'citation': 'Wong D, Cazabon S, Ali H, Kumar I, Valldeperas X, Groenewald C, Pearce I. Can the sequential use of conventional silicone oil and heavy oil be a strategy for the management of proliferative vitreoretinopathy? Ann Acad Med Singap. 2006 Mar;35(3):181-4.'}, {'pmid': '16523153', 'type': 'BACKGROUND', 'citation': 'Scheer S, Boni S, Barale PO, Bourhis A, Bonnel S, Tuil E, Girmens JF, Buil O, Baudouin C, Laroche L, Nordmann JP, Poisson F, Warnet JM, Sahel JA. [Heavy silicone oil as internal tamponade for retinal detachment: efficacy and tolerance]. J Fr Ophtalmol. 2006 Feb;29(2):129-35. doi: 10.1016/s0181-5512(06)73760-3. French.'}, {'pmid': '16139666', 'type': 'BACKGROUND', 'citation': 'Tognetto D, Minutola D, Sanguinetti G, Ravalico G. Anatomical and functional outcomes after heavy silicone oil tamponade in vitreoretinal surgery for complicated retinal detachment: a pilot study. Ophthalmology. 2005 Sep;112(9):1574. doi: 10.1016/j.ophtha.2005.04.013.'}, {'pmid': '15923493', 'type': 'BACKGROUND', 'citation': 'Bhisitkul RB, Gonzalez VH. "Heavy oil" for intraocular tamponade in retinal detachment surgery. Br J Ophthalmol. 2005 Jun;89(6):649-50. doi: 10.1136/bjo.2004.057182. No abstract available.'}, {'pmid': '12824833', 'type': 'BACKGROUND', 'citation': 'Wolf S, Schon V, Meier P, Wiedemann P. Silicone oil-RMN3 mixture ("heavy silicone oil") as internal tamponade for complicated retinal detachment. Retina. 2003 Jun;23(3):335-42. doi: 10.1097/00006982-200306000-00008.'}, {'pmid': '15983817', 'type': 'BACKGROUND', 'citation': 'Rizzo S, Genovesi-Ebert F, Belting C, Vento A, Cresti F. A pilot study on the use of silicone oil-RMN3 as heavier-than-water endotamponade agent. Graefes Arch Clin Exp Ophthalmol. 2005 Nov;243(11):1153-7. doi: 10.1007/s00417-005-0015-6. Epub 2005 Jun 28.'}, {'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 the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.', 'detailedDescription': 'Five to 10% of retinal detachments progressed to proliferative vitreoretinopathy (PVR), the common more cause of surgical failure of retina detachment.\n\nDespite the use of internal tamponades, the treatment of retinal detachments due to a progressed proliferative vitreoretinopathy (PVR) is still a problem. At present, conventional silicone oil, having a lower specific gravity than water, is an excellent tool in advanced PVR retinal detachment especially of the upper circumference.\n\nIn the past, to diminish the re-detachments diverse heavier-than-water density endotamponades were investigated by to use in in cases of inferior PVR. However,heavier-than-water density endotamponades have demonstrated adverse short term effects. (Example: silicon dispersion: hypotension and inflammation)\n\nRecently, two new long-term heavier-than-water internal tamponades were introduced: Oxane HD \\[oil-RMN3-mixture\\] and Densiron \\[mixture of 30.5 vol% perfluorohexyloctane (F6H8) with 69.5 vol% polydimethylsiloxane (silicone oil)\\], showing satisfying anatomical results and good intraocular tolerance.\n\nIn the present study, we will compare the anatomical outcome, functional results and intraocular adverse effects of two types of heavier tamponades.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy\n\nExclusion Criteria:\n\n* Diabetes\n* Uveitis\n* Glaucoma'}, 'identificationModule': {'nctId': 'NCT00403702', 'briefTitle': 'Comparison High-density Silicone Oils in Retinal Detachment', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment', 'orgStudyIdInfo': {'id': 'APEC-0021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oxane HD [oil-RMN3-mixture]', 'type': 'DRUG'}, {'name': 'Densiron [(F6H8)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04330', 'city': 'México', 'state': 'D.F', 'country': 'Mexico', 'facility': 'Asociacion Para Evitar la Ceguera en Mexico', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}], 'overallOfficials': [{'name': 'Hugo Quiroz-Mercado, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}}}}