Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 3:32 PM
Study NCT ID:
NCT02911532
Status:
UNKNOWN
Last Update Posted:
2017-08-16
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival 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': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-12', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The epithelial defect size of the transplanted tissue engineering conjunctiva', 'timeFrame': 'the 7 days after operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pterygium', 'tissue engineering', 'atretoblepharia'], 'conditions': ['Pterygium']}, 'referencesModule': {'references': [{'pmid': '23594771', 'type': 'BACKGROUND', 'citation': 'Varssano D, Shalev H, Lazar M, Fischer N. Pterygium excision with conjunctival autograft: true survival rate statistics. Cornea. 2013 Sep;32(9):1243-50. doi: 10.1097/ICO.0b013e31828ce09c.'}, {'pmid': '23775605', 'type': 'BACKGROUND', 'citation': 'Mahar PS, Manzar N. The study of etiological and demographic characteristics of pterygium recurrence: a consecutive case series study from Pakistan. Int Ophthalmol. 2014 Feb;34(1):69-74. doi: 10.1007/s10792-013-9797-4. Epub 2013 Jun 18.'}, {'pmid': '19092404', 'type': 'BACKGROUND', 'citation': 'Farid M, Pirnazar JR. Pterygium recurrence after excision with conjunctival autograft: a comparison of fibrin tissue adhesive to absorbable sutures. Cornea. 2009 Jan;28(1):43-5. doi: 10.1097/ICO.0b013e318183a362.'}, {'pmid': '23062647', 'type': 'BACKGROUND', 'citation': 'Kaufman SC, Jacobs DS, Lee WB, Deng SX, Rosenblatt MI, Shtein RM. Options and adjuvants in surgery for pterygium: a report by the American Academy of Ophthalmology. Ophthalmology. 2013 Jan;120(1):201-8. doi: 10.1016/j.ophtha.2012.06.066. Epub 2012 Oct 11.'}, {'pmid': '9338666', 'type': 'BACKGROUND', 'citation': 'Tan DT, Chee SP, Dear KB, Lim AS. Effect of pterygium morphology on pterygium recurrence in a controlled trial comparing conjunctival autografting with bare sclera excision. Arch Ophthalmol. 1997 Oct;115(10):1235-40. doi: 10.1001/archopht.1997.01100160405001.'}, {'pmid': '23733279', 'type': 'BACKGROUND', 'citation': 'Sandra S, Zeljka J, Zeljka VA, Kristian S, Ivana A. The influence of pterygium morphology on fibrin glue conjunctival autografting pterygium surgery. Int Ophthalmol. 2014 Feb;34(1):75-9. doi: 10.1007/s10792-013-9799-2. Epub 2013 Jun 4.'}, {'pmid': '8152771', 'type': 'BACKGROUND', 'citation': 'Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. doi: 10.1016/s0161-6420(94)31270-x.'}, {'pmid': '19339811', 'type': 'BACKGROUND', 'citation': 'Ozer A, Yildirim N, Erol N, Yurdakul S. Long-term results of bare sclera, limbal-conjunctival autograft and amniotic membrane graft techniques in primary pterygium excisions. Ophthalmologica. 2009;223(4):269-73. doi: 10.1159/000210444. Epub 2009 Apr 2.'}, {'pmid': '22643650', 'type': 'BACKGROUND', 'citation': 'Zheng K, Cai J, Jhanji V, Chen H. Comparison of pterygium recurrence rates after limbal conjunctival autograft transplantation and other techniques: meta-analysis. Cornea. 2012 Dec;31(12):1422-7. doi: 10.1097/ICO.0b013e31823cbecb.'}, {'pmid': '12686302', 'type': 'BACKGROUND', 'citation': 'Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.'}, {'pmid': '21935607', 'type': 'BACKGROUND', 'citation': 'Li M, Zhu M, Yu Y, Gong L, Zhao N, Robitaille MJ. Comparison of conjunctival autograft transplantation and amniotic membrane transplantation for pterygium: a meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2012 Mar;250(3):375-81. doi: 10.1007/s00417-011-1820-8. Epub 2011 Sep 21.'}, {'pmid': '22892149', 'type': 'BACKGROUND', 'citation': 'Hirst LW. Recurrence and complications after 1,000 surgeries using pterygium extended removal followed by extended conjunctival transplant. Ophthalmology. 2012 Nov;119(11):2205-10. doi: 10.1016/j.ophtha.2012.06.021. Epub 2012 Aug 11.'}, {'pmid': '10690823', 'type': 'BACKGROUND', 'citation': 'Gris O, Guell JL, del Campo Z. Limbal-conjunctival autograft transplantation for the treatment of recurrent pterygium. Ophthalmology. 2000 Feb;107(2):270-3. doi: 10.1016/s0161-6420(99)00041-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.', 'detailedDescription': 'The most important area for research on the pterygium are the recurrence occurred after operation. Now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. For the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. In this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Primary and recurrent pterygium patients,atretoblepharia patients\n2. Voluntarily signed informed consent\n3. No surgery and anesthesia contraindications.\n\nExclusion Criteria:\n\n1. The patients combined systemic diseases\n2. Reject study and follow visit\n3. Patients don't accept the tissue engineering conjunctiva\n4. Cannot tolerate surgery or anesthesia"}, 'identificationModule': {'nctId': 'NCT02911532', 'acronym': 'TECTPA', 'briefTitle': 'Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Eye Hospital'}, 'officialTitle': 'Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia', 'orgStudyIdInfo': {'id': '20160816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optical Coherence tomography', 'interventionNames': ['Procedure: Tissue engineering conjunctiva transplantation']}], 'interventions': [{'name': 'Tissue engineering conjunctiva transplantation', 'type': 'PROCEDURE', 'description': 'During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position', 'armGroupLabels': ['Optical Coherence tomography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suxia Li', 'role': 'CONTACT', 'email': 'ykyykjk@163.com', 'phone': '15854107085'}], 'facility': 'Shandong Eye Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Suxia Li, researcher', 'role': 'CONTACT', 'email': 'ykyykjk@163.com', 'phone': '8615854107085'}, {'name': 'Hua Gao, researcher', 'role': 'CONTACT', 'email': 'gaohua100@126.com', 'phone': '8613705312702'}], 'overallOfficials': [{'name': 'Weiyun Shi, sponsor', 'role': 'STUDY_CHAIR', 'affiliation': 'director of shandong eye hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}