Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Corneal Ulcer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Ulcer
• Ulcer

• NCT number: NCT01244776
• Study type: Interventional
• Source: Shaanxi Aierfu Activtissue Engineering
• Contact: Yongbo Lu
• Phone: 86-29-84776153
• Email: yongerbo@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: April 2010
• Completion date: July 2012