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Clinical Trials/NCT02911532
NCT02911532
Unknown
Not Applicable

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

Shandong Eye Hospital1 site in 1 country60 target enrollmentOctober 1, 2016
ConditionsPterygium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pterygium
Sponsor
Shandong Eye Hospital
Enrollment
60
Locations
1
Primary Endpoint
The epithelial defect size of the transplanted tissue engineering conjunctiva
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
April 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shandong Eye Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The epithelial defect size of the transplanted tissue engineering conjunctiva

Time Frame: the 7 days after operation

Study Sites (1)

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