Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Corneal Ulcer |
Device: acellular corneal matrix |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 100 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Yongbo Lu | 86-29-84776153 | yongerbo@gmail.com |
| China, Beijing | |
| Beijing Tongren Hospital | Recruiting |
| Beijing, Beijing, China, 100730 | |
| Contact: Liuhe Zhou | |
| Principal Investigator: | Liuhe Zhou, M.D. | Beijing Tongren Hospital |
More Information
No publications provided
| Responsible Party: | youngbo lu, Shaanxi Aierfu Activtissue Engineering |
| ClinicalTrials.gov Identifier: | NCT01244776 History of Changes |
| Other Study ID Numbers: | TEC 01 |
| Study First Received: | November 18, 2010 |
| Last Updated: | May 5, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Corneal Ulcer Ulcer Eye Infections Infection |
Keratitis Corneal Diseases Eye Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013