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

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ClinicalTrials.gov Identifier: NCT02911532
Recruitment Status : Unknown
Verified August 2017 by Shandong Eye Hospital.
Recruitment status was:  Recruiting
First Posted : September 22, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Shandong Eye Hospital

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

Condition or disease Intervention/treatment Phase
Pterygium Procedure: Tissue engineering conjunctiva transplantation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : April 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Optical Coherence tomography Procedure: Tissue engineering conjunctiva transplantation
During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position


Outcome Measures
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Primary Outcome Measures :
  1. The epithelial defect size of the transplanted tissue engineering conjunctiva [ Time Frame: the 7 days after operation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911532


Contacts
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Contact: Suxia Li, researcher 8615854107085 ykyykjk@163.com
Contact: Hua Gao, researcher 8613705312702 gaohua100@126.com

Locations
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China, Shandong
Shandong Eye Hospital Recruiting
Jinan, Shandong, China, 250000
Contact: Suxia Li    15854107085    ykyykjk@163.com   
Sponsors and Collaborators
Shandong Eye Hospital
Investigators
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Study Chair: Weiyun Shi, sponsor director of shandong eye hospital
More Information
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Publications:

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Responsible Party: Shandong Eye Hospital
ClinicalTrials.gov Identifier: NCT02911532    
Other Study ID Numbers: 20160816
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shandong Eye Hospital:
pterygium
tissue engineering
atretoblepharia
Additional relevant MeSH terms:
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Pterygium
Conjunctival Diseases
Eye Diseases