Xenogenic Keratoplasty From Porcine Cornea (XKFPC)

July 16, 2015 updated by: Zuguo Liu, Xiamen University

Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361005
        • Xiamen University Affiliated Xiamen Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Xenogenic cornea
Genetic: Xenogenic cornea
lamellar acellular xenogenic corneas were sterilised by radiation
ACTIVE_COMPARATOR: human cornea
Genetic: homogenic cornea
homogenic corneas were sterilised by radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of rejection in three months after keratoplasty
Time Frame: three months after lamellar keratoplasty
  1. Rate of epithelium rejection Epithelial rejection performances: 1.1 epithelium edema, OR 1.2 epithelium opacity, OR 1.3 epithelial rejection line.
  2. Rate of stroma rejection Stroma rejection performances: 2.1 stroma edema, OR 2.2 stroma opacity, OR 2.3 suture loosing.
three months after lamellar keratoplasty

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy
Time Frame: one year

Shapes and location:

  1. Sub-epithelial nerve plex is in the depth between 35um to 65um shaping like white thin line with branches in vivo confocal microscopy.
  2. Sromal nerve is in the stromal layer(about 70um to 500um) shaping like white thick trunk with branches in vivo confocal microscopy.
  3. Stromal keratocytes is in the stromal layer like white rod-shape in vivo confocal microscopy.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen University

Investigators

  • Study Director: Zuguo Liu, PhD, Eye Institute of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (ESTIMATE)

September 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EIXM-XKFPC-20110901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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