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Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia (TECTPA)

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tissue engineering conjunctiva transplantation
Sponsored by
Shandong Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring pterygium, tissue engineering, atretoblepharia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shandong Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optical Coherence tomography

Arm Description

Outcomes

Primary Outcome Measures

The epithelial defect size of the transplanted tissue engineering conjunctiva

Secondary Outcome Measures

Full Information

First Posted
August 26, 2016
Last Updated
August 12, 2017
Sponsor
Shandong Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02911532
Brief Title
Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia
Acronym
TECTPA
Official Title
Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Eye Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
pterygium, tissue engineering, atretoblepharia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optical Coherence tomography
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Tissue engineering conjunctiva transplantation
Intervention Description
During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position
Primary Outcome Measure Information:
Title
The epithelial defect size of the transplanted tissue engineering conjunctiva
Time Frame
the 7 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary and recurrent pterygium patients,atretoblepharia patients Voluntarily signed informed consent No surgery and anesthesia contraindications. Exclusion Criteria: The patients combined systemic diseases Reject study and follow visit Patients don't accept the tissue engineering conjunctiva Cannot tolerate surgery or anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suxia Li, researcher
Phone
8615854107085
Email
ykyykjk@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Gao, researcher
Phone
8613705312702
Email
gaohua100@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiyun Shi, sponsor
Organizational Affiliation
director of shandong eye hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Eye Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suxia Li
Phone
15854107085
Email
ykyykjk@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23594771
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.
Results Reference
background
PubMed Identifier
23775605
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.
Results Reference
background
PubMed Identifier
19092404
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.
Results Reference
background
PubMed Identifier
23062647
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.
Results Reference
background
PubMed Identifier
9338666
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. Erratum In: Arch Ophthalmol 1998 Apr;116(4):552.
Results Reference
background
PubMed Identifier
23733279
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.
Results Reference
background
PubMed Identifier
8152771
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.
Results Reference
background
PubMed Identifier
19339811
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.
Results Reference
background
PubMed Identifier
22643650
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.
Results Reference
background
PubMed Identifier
12686302
Citation
Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.
Results Reference
background
PubMed Identifier
21935607
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.
Results Reference
background
PubMed Identifier
22892149
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.
Results Reference
background
PubMed Identifier
10690823
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.
Results Reference
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Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia

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