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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

Tracking Information
First Submitted Date  ICMJE August 26, 2016
First Posted Date  ICMJE September 22, 2016
Last Update Posted Date August 16, 2017
Actual Study Start Date  ICMJE October 1, 2016
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
The epithelial defect size of the transplanted tissue engineering conjunctiva [ Time Frame: the 7 days after operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia
Official Title  ICMJE Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pterygium
Intervention  ICMJE Procedure: Tissue engineering conjunctiva transplantation
During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position
Study Arms  ICMJE Experimental: Optical Coherence tomography
Intervention: Procedure: Tissue engineering conjunctiva transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 19, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2018
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02911532
Other Study ID Numbers  ICMJE 20160816
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shandong Eye Hospital
Study Sponsor  ICMJE Shandong Eye Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Weiyun Shi, sponsor director of shandong eye hospital
PRS Account Shandong Eye Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP