Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-26 @ 7:27 AM
Study NCT ID:
NCT01959568
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2013-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2013-09-29', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of patients with intraocular pressure >/= 25 mm Hg', 'timeFrame': 'in 1 month after tamponade removal.'}, {'measure': 'Percentage of phakic eyes in which cataract occurred during tamponade', 'timeFrame': 'During tamponade removal.'}, {'measure': 'Percentage of eyes with tamponing substances emulsification', 'timeFrame': 'During tamponade removal.'}, {'measure': 'Thickness of retinal inner and outer nuclear layers', 'timeFrame': 'in 1 month after tamponade removal', 'description': 'Measured with Optical Coherence Tomography'}, {'measure': 'Retinal light sensitivity', 'timeFrame': 'in 1 month after tamponade removal', 'description': 'Measured with microperimetry'}], 'primaryOutcomes': [{'measure': 'Retinal reattachment rate', 'timeFrame': 'in 1 month after tamponade removal.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with best corrected visual acuity >/= 20.200', 'timeFrame': 'in 1 month after tamponade removal'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Retinal Detachment', 'Double Tamponade', 'Perfluorocarbon liquids', 'Vitrectomy'], 'conditions': ['Retinal Detachment']}, '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': 'Purpose: to assess the efficacy and safety of double tamponade versus silicone oil tamponade.\n\nDesign: parallel-group study with balanced \\[1:1\\] stratified block randomization. Eligible participants are all adults aged 18 or over with first diagnosed rhegmatogenous total retinal detachment with retinal breaks located both in upper and lower retina. Also investigators include those patients with total retinal detachment with proliferative vitreoretinopathy (PVR) in which it is impossible to remove epiretinal membranes completely during the surgery (with arbitrary retinal breaks localization). Exclusion criteria are severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas etc) and eye length more than 27mm.\n\nPatients are randomized in two groups (test group and control group).\n\nIn the test group patients undergo subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin (PFD) tamponade, retinal photocoagulation. After that the surgeon replaces ½ of PFD volume by "conventional" SO (with density less than one of water). The result is vitreous cavity (VC) filled in a half with PFD and in another half - with SO. In the control group patients undergo subtotal vitrectomy, epiretinal membrane removal, PFD tamponade, retinal photocoagulation and PFD-SO exchange, so the result is VC filled with "conventional" or heavy SO, depending on predominant retinal breaks location. 30 days after the surgery in both groups tamponing agents are removed from VC and VC is filled with sulfur hexafluoride gas (SF6) which dissolves during 1 month. Follow-up is at least 12 months.\n\nAlong with standard examinations, after SF6 gas dissolution investigators perform spectral optical coherence tomography (OCT) and microperimetry. With OCT investigators measure thickness of retinal inner and outer nuclear layers. With microperimetry investigators determine light sensitivity in 12° and 4° zones from the fixation point.\n\nOutcome measures: reattachment rate, best corrected visual acuity (BCVA), intraocular pressure (IOP), thicknesses of inner and outer nuclear layers according to the OCT, light sensitivity according to microperimetry, the rate of cataract formation in phakic eyes and the rate of tamponing agents emulsification.\n\nFor final analysis each group will include 145 participants.\n\nOCT, microperimetry data and visual acuity will be compared between the groups using Student\'s t-test; proportions will be compared using exact Fisher\'s test.', 'detailedDescription': 'The investigators include in the study all successive patients operated by the same surgeon. The study takes place in the S.N. Fyodorov "Eye Microsurgery" Federal State Institution located in Moscow, Russian Federation.\n\nPatients are randomized in two groups with stratified block randomization. Strata were defined by combination of two binary prognostic factors: duration of retinal detachment (less than 3 months and ≥ 3 months) and PVR (present/absent).\n\nEarly interim analysis will be performed in order to reveal possible adverse effect of long-term PFD tamponade. For interim report success will mean the rate of post-surgical BCVA \\>/= 20.200. Groups sizes for interim analysis will be 35 patients in each group. For interim analysis the investigators choose group sizes able to reveal 30% absolute difference in functional success rate with one-sided test (to detect possible toxicity of double tamponade for the retina) having power of 0.8 and significance level of p=0.05. In the final analysis success will mean retinal reattachment.\n\nFor final analysis each group will include 145 participants, so that the investigators are able to detect 15% difference in reattachment rate with power of 0.8 and significance level of p=0.05. Group sizes were computed with exact Fisher\'s test function in G\\*Power 3.1.7 software (Erdfelder, Faul, \\& Buchner).\n\nOCT is performed with Cirrus HD-OCT system (Zeiss Meditec Inc). Microperimetry is performed with MP-1 microperimeter (Nidek). All the examinations are assessed by one ophthalmologist.\n\nThe allocation concealment is implemented with the help of a third party, who stores the randomization list and prepares envelopes containing directions what method of tamponade to employ in each particular patient. Patients are blind to the method of tamponade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 or over with firstly diagnosed rhegmatogenous total retinal detachment:\n\n1. with retinal breaks located both in upper and lower retina; OR\n2. with PVR which was impossible to remove completely during the surgery.\n\nExclusion Criteria:\n\n1. severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); OR\n2. eye length more than 27mm.'}, 'identificationModule': {'nctId': 'NCT01959568', 'briefTitle': 'Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The S.N. Fyodorov Eye Microsurgery State Institution'}, 'officialTitle': 'Double Endotamponade With Perfluorodecalin and Silicone Oil in Retinal Detachment Surgery: Randomised Clinical Trial of Safety', 'orgStudyIdInfo': {'id': '#8, 04/09/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double tamponade', 'description': 'Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation. After that the surgeon replaces ½ of perfluorodecalin volume by silicone oil.', 'interventionNames': ['Procedure: Vitrectomy and tamponade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Silicone oil tamponade', 'description': 'Vitrectomy and tamponade: subtotal vitrectomy, epiretinal membrane removal, perfluorodecalin tamponade, retinal photocoagulation and perfluorodecalin-silicone oil exchange.', 'interventionNames': ['Procedure: Vitrectomy and tamponade']}], 'interventions': [{'name': 'Vitrectomy and tamponade', 'type': 'PROCEDURE', 'otherNames': ['Perfluorodecalin Dk-Line (Bausch&Lomb)', 'Silicone oil Oxane 1300 (Bausch&Lomb)', 'Silicone oil Oxane HD (Bausch&Lomb)'], 'description': 'In the double tamponade arm the result of surgery is vitreous cavity filled in a half with perfluorodecalin and in another half - with silicone oil.\n\nIn the silicone oil tamponade arm the result of surgery is vitreous cavity filled with "conventional" or heavy silicone oil, depending on predominant retinal breaks location.', 'armGroupLabels': ['Double tamponade', 'Silicone oil tamponade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '127486', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Pavel V Lyskin, PhD', 'role': 'CONTACT', 'email': 'plyskin@yahoo.com', 'phone': '+79165558019'}, {'name': 'Elena G Kazimirova, MD', 'role': 'CONTACT', 'email': 'lena.kazimirova@gmail.com', 'phone': '+79165898410'}, {'name': 'Pavel V Lyskin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elena G Kazimirova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'SN Fyodorov "Eye Microsurgery" State Institution', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Pavel V Lyskin, PhD', 'role': 'CONTACT', 'email': 'plyskin@yahoo.com', 'phone': '+79165558019'}, {'name': 'Elena G Kazimirova, MD', 'role': 'CONTACT', 'email': 'lena.kazimirova@gmail.com', 'phone': '+79165898410'}], 'overallOfficials': [{'name': 'Pavel V Lyskin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SN Fyodorov "Eye Microsurgery" State Institution'}, {'name': 'Valery D Zakharov, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SN Fyodorov "Eye Microsurgery" State Institution'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The S.N. Fyodorov Eye Microsurgery State Institution', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pavel V. Lyskin, MD, PhD', 'investigatorFullName': 'Pavel V. Lyskin', 'investigatorAffiliation': 'The S.N. Fyodorov Eye Microsurgery State Institution'}}}}