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

August 12, 2017 updated by: Shandong Eye Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Suxia Li, researcher
  • Phone Number: 8615854107085
  • Email: ykyykjk@163.com

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The epithelial defect size of the transplanted tissue engineering conjunctiva
Time Frame: the 7 days after operation
the 7 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Eye Hospital

Investigators

  • Study Chair: Weiyun Shi, sponsor, director of shandong eye hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 12, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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