Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Not Applicable

• Conditions: Corneal Ulcer
• Interventions: Device: acellular corneal matrix

• Registration Number: NCT01244776
• Lead Sponsor: Shaanxi Aierfu Activtissue Engineering

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 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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-06
• Primary Completion: 2011-12
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients aged between 18 and 75 yrs.
• Corneal ulcer.
• Informed consent.

Exclusion Criteria

• Corneal perforation.
• Other ocular diseases.
• The presence of systemic connective tissue diseases
• Severe allergic constitution
• Pregnancy
• The presence of chronic disease, such as significant cardiovascular illness
• The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
• Any patient that is not suitable for recruitment, in the judgment of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acellular corneal matrix	acellular corneal matrix	-

Primary Outcome Measures

Name	Time	Method
Rejection evaluation	30 days following transplantation

Secondary Outcome Measures

Name	Time	Method
Corneal wound healing	90 days following transplantation

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China