Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT02201706
Status:
UNKNOWN
Last Update Posted:
2015-05-07
First Post:
2014-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2014-07-15', 'studyFirstSubmitQcDate': '2014-07-25', 'lastUpdatePostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retina reattachment rate', 'timeFrame': '3 months after the surgery'}], 'secondaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': 'Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.'}, {'measure': 'The degree of recurrent PVR', 'timeFrame': 'Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.'}, {'measure': 'The incidence of intraocular hemorrhage', 'timeFrame': 'Before surgery, 3days,1 week, 2 weeks, 4 weeks, 3 months and 6 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Retinal detachment', 'silicone oil', 'retinectomy'], 'conditions': ['Retinal Detachment']}, 'referencesModule': {'references': [{'pmid': '23601479', 'type': 'BACKGROUND', 'citation': 'Romaniuk VM. Ocular trauma and other catastrophes. Emerg Med Clin North Am. 2013 May;31(2):399-411. doi: 10.1016/j.emc.2013.02.003.'}, {'pmid': '2334327', 'type': 'BACKGROUND', 'citation': 'Han DP, Lewis MT, Kuhn EM, Abrams GW, Mieler WF, Williams GA, Aaberg TM. Relaxing retinotomies and retinectomies. Surgical results and predictors of visual outcome. Arch Ophthalmol. 1990 May;108(5):694-7. doi: 10.1001/archopht.1990.01070070080039.'}, {'pmid': '18556423', 'type': 'BACKGROUND', 'citation': 'de Silva DJ, Kwan A, Bunce C, Bainbridge J. Predicting visual outcome following retinectomy for retinal detachment. Br J Ophthalmol. 2008 Jul;92(7):954-8. doi: 10.1136/bjo.2007.131540. Epub 2008 Jun 12.'}, {'pmid': '27022477', 'type': 'DERIVED', 'citation': 'Jiang Z, Qiu S, Lou B, Lin M, Tan J, Lin X. Radial Retinotomies with Endodiathermy for Severe Proliferative Vitreoretinopathy: Short-Term Results. J Ophthalmol. 2016;2016:2594574. doi: 10.1155/2016/2594574. Epub 2016 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a complex retinal detachment with poor prognosis.\n\nIn this study, the investigators try to apply a modified surgery as Multi-electrocoagulation retinectomy to reattach the retina. Here the investigators aimed to explore the safety and efficacy of this new surgical approach', 'detailedDescription': 'The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone oil filled. However, it has some obvious disadvantages such as the cut of the normal retina surrounding, leaving a large area of retinal deficiency and significant exposure of retinal pigment epithelium and choroid membranes.\n\nIn this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy to re-attach the retina.\n\nInstead of cutting through the proliferated retina directly, this new surgical approach adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation.\n\nIn this way, we not only relax the traction of the proliferative membranes, but also reserve the rest retina to cover the RPE layers.\n\nBased on the hypothesis above, we are aiming to explore the safety and efficacy of this new surgical approach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 5-60 years, male or female\n2. The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now.\n3. The presence of inferior retinal re-detachment located among 3-9 o'clock.\n\nExclusion Criteria:\n\n1. The primary retinal detachment was not caused by ocular trauma.\n2. Location of the re-detached retina is not mainly in the inferior of the eye.\n3. The fundus is unobservable because of severe corneal opacity.\n4. The contralateral eye is non-functional\n5. Serious heart, lung, liver and kidney dysfunction"}, 'identificationModule': {'nctId': 'NCT02201706', 'briefTitle': 'Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Explore Study for the Efficacy and Safety of Multi-electrocoagulation Retinectomy in the Treatment of Retinal Re-detachment in Silicone Oil Filled Eye', 'orgStudyIdInfo': {'id': 'MER201407'}, 'secondaryIdInfos': [{'id': 'MER201407', 'type': 'OTHER', 'domain': 'SunYat-senU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-electrocoagulation retinectomy', 'description': 'Retinal re-detachment in eyes with silicone oil filled,a modified surgery named Multi-electrocoagulation retinectomy will be used to re-attach the retina.', 'interventionNames': ['Procedure: Multi-electrocoagulation retinectomy']}], 'interventions': [{'name': 'Multi-electrocoagulation retinectomy', 'type': 'PROCEDURE', 'description': 'a modified surgery named "multi-electrocoagulation retinectomy" to re-attach the retina.\n\nAll the single surgical technique and devices involved in this modified surgery are used commonly in clinic.\n\nBase on this, the investigator changes the traditional sequence of these single surgical techniques, and combine them into a new surgical process.', 'armGroupLabels': ['Multi-electrocoagulation retinectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Lin, Dr', 'role': 'CONTACT', 'email': 'linxiaof@mail.sysu.edu.cn', 'phone': '02087330000'}, {'name': 'Xiaofeng Lin, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center of Sun yat-sen Universtiy', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaofeng Lin, Dr', 'role': 'CONTACT', 'email': 'linxiaof@mail.sysu.edu.cn', 'phone': '02087330000'}], 'overallOfficials': [{'name': 'Xiaofeng Lin, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center of Sun yat-sen Universtiy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice-president', 'investigatorFullName': 'Xiaofeng Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}