Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Shaanxi Aierfu Activtissue Engineering

Status: Unknown

Conditions: Corneal Ulcer

Treatments: Device: acellular corneal matrix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01244776

TEC 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Acellular corneal matrix

Experimental group

Treatment:

Device: acellular corneal matrix