Corneal Ulcer
Conditions
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.
Interventions
DEVICEacellular corneal matrix
Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.
Sponsors
Shenzhen AiNear Cornea Engineering Company Limited
Air Force Military Medical University, China
Engineering Technology Center for Tissue Engineering of Xi'an
Beijing Tongren Hospital
West China Hospital
Henan Provincial People's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Southwest Hospital, China
Shaanxi Aierfu Activtissue Engineering
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rejection evaluation | 30 days following transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Corneal wound healing | 90 days following transplantation |
Countries
China
Contacts
Primary ContactYongbo Lu
Outcome results
None listed