Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Corneal Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acellular corneal matrix

Group Type EXPERIMENTAL

acellular corneal matrix

Intervention Type DEVICE

Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.

Interventions

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acellular corneal matrix

Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.

Intervention Type DEVICE

Other Intervention Names

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ACM

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No