Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shenzhen AiNear Cornea Engineering Company Limited | UNKNOWN |
| Air Force Military Medical University, China | OTHER |
| Engineering Technology Center for Tissue Engineering of Xi'an | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular corneal matrix | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acellular corneal matrix | Device | Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rejection evaluation | 30 days following transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal wound healing | 90 days following transplantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongbo Lu | Contact | 86-29-84776153 | yongerbo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liuhe Zhou, M.D. | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
Not provided
| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
Not provided
Not provided
| Beijing Tongren Hospital | OTHER |
| West China Hospital | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Southwest Hospital, China | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D005128 |
| Eye Diseases |