Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer|
- Rejection evaluation [ Time Frame: 30 days following transplantation ] [ Designated as safety issue: Yes ]
- Corneal wound healing [ Time Frame: 90 days following transplantation ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Acellular corneal matrix||
Device: acellular corneal matrix
Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.
Other Name: ACM
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244776
|Contact: Yongbo Lufirstname.lastname@example.org|
|Beijing Tongren Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Liuhe Zhou|
|Principal Investigator:||Liuhe Zhou, M.D.||Beijing Tongren Hospital|