Clinical Trial: Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Brief Summary: This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

Detailed Summary: Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.
Sponsor: Shaanxi Aierfu Activtissue Engineering

Current Primary Outcome: Rejection evaluation [ Time Frame: 30 days following transplantation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Corneal wound healing [ Time Frame: 90 days following transplantation ]

Original Secondary Outcome: Same as current

Information By: Shaanxi Aierfu Activtissue Engineering

Dates:
Date Received: November 18, 2010
Date Started: April 2010
Date Completion: July 2012
Last Updated: May 5, 2011
Last Verified: May 2011