Xenogenic Keratoplasty From Porcine Cornea

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

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-12-31

Brief Summary

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Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.

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Detailed Description

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Acellular porcine cornea eligibility criteria:

1. fresh porcine cornea,
2. porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
3. porcine cornea keeping integrative corneal epithelium and endothelium,
4. acellular porcine cornea keeping transparent.

Conditions

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Porcine Corneal Xenograph

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Xenogenic cornea

Group Type EXPERIMENTAL

Xenogenic cornea

Intervention Type GENETIC

lamellar acellular xenogenic corneas were sterilised by radiation

human cornea

Group Type ACTIVE_COMPARATOR

homogenic cornea

Intervention Type GENETIC

homogenic corneas were sterilised by radiation

Interventions

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Xenogenic cornea

lamellar acellular xenogenic corneas were sterilised by radiation

Intervention Type GENETIC

homogenic cornea

homogenic corneas were sterilised by radiation

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Patients with severe infectious corneal ulcer
* The ulcers can not be controlled with existing antibiotics eye drops or medicine after 1 week treatment
* The infected corneas have risks of penetrating
* The depth of ulcers are less than 400um
* The bridge of the ulcers is away from corneal limbal more than 1mm
* Patients aged 18 or older
* Patients able and willing to sign the informed consent form

Exclusion Criteria

* Patients with severe infectious corneal ulcer in stable stage
* Patients with corneal ulcers after viruses infection, such as herpes simplex virus
* Patients with corneal ulcers from non-infectious factors, such as toxicity, burn or immunological inflammation
* The ulcers are not cover pupil zone and will not result in visional defect in future
* The depth of ulcer is less than 50um
* Patients has history of keratoplasty surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No