Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia
TECTPA
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedAugust 16, 2017
August 1, 2017
1 year
August 26, 2016
August 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The epithelial defect size of the transplanted tissue engineering conjunctiva
the 7 days after operation
Study Arms (1)
Optical Coherence tomography
EXPERIMENTALInterventions
During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position
Eligibility Criteria
You may qualify if:
- Primary and recurrent pterygium patients,atretoblepharia patients
- Voluntarily signed informed consent
- No surgery and anesthesia contraindications.
You may not qualify if:
- The patients combined systemic diseases
- Reject study and follow visit
- Patients don't accept the tissue engineering conjunctiva
- Cannot tolerate surgery or anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Eye Hospital
Jinan, Shandong, 250000, China
Related Publications (13)
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: 23594771BACKGROUNDMahar 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: 23775605BACKGROUNDFarid 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: 19092404BACKGROUNDKaufman 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: 23062647BACKGROUNDTan 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: 9338666BACKGROUNDSandra 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: 23733279BACKGROUNDHirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. doi: 10.1016/s0161-6420(94)31270-x.
PMID: 8152771BACKGROUNDOzer 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: 19339811BACKGROUNDZheng 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: 22643650BACKGROUNDHirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.
PMID: 12686302BACKGROUNDLi 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: 21935607BACKGROUNDHirst 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: 22892149BACKGROUNDGris 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.
PMID: 10690823BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weiyun Shi, sponsor
director of shandong eye hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
September 22, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
April 1, 2018
Last Updated
August 16, 2017
Record last verified: 2017-08