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NCT02911532 Clinical Trial

Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia

Pterygium Clinical Trial

— TECTPA  

Official title:
Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02911532
Other study ID # 20160816
Secondary ID
Status Recruiting
Phase N/A
First received August 26, 2016
Last updated August 12, 2017
Start date October 1, 2016
Est. completion date April 1, 2018

Study information
Verified date August 2017
Source Shandong Eye Hospital
Contact Suxia Li, researcher
Phone 8615854107085
Email ykyykjk@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date April 1, 2018
Est. primary completion date October 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Primary and recurrent pterygium patients,atretoblepharia patients

2. Voluntarily signed informed consent

3. No surgery and anesthesia contraindications.

Exclusion Criteria:

1. The patients combined systemic diseases

2. Reject study and follow visit

3. Patients don't accept the tissue engineering conjunctiva

4. Cannot tolerate surgery or anesthesia

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Tissue engineering conjunctiva transplantation
During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position

Locations
Country Name City State
China Shandong Eye Hospital Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View Citation

Gris O, Güell JL, del Campo Z. Limbal-conjunctival autograft transplantation for the treatment of recurrent pterygium. Ophthalmology. 2000 Feb;107(2):270-3. — View Citation

Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. — View 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. — View Citation

Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum in: Arch Ophthalmol 1998 Apr;116(4):552. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary The epithelial defect size of the transplanted tissue engineering conjunctiva the 7 days after operation
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