Xenogenic Keratoplasty From Porcine Cornea (XKFPC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Xiamen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zuguo Liu, Xiamen University
ClinicalTrials.gov Identifier:
NCT01443559
First received: September 19, 2011
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Corneal Transplantation
Genetic: Xenogenic cornea
Genetic: homogenic cornea
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer

Resource links provided by NLM:


Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • Rate of rejection in three months after keratoplasty [ Time Frame: three months after lamellar keratoplasty ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    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.


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443559

Locations
China, Fujian
Xiamen University Affiliated Xiamen Eye Center Recruiting
Xiamen, Fujian, China, 361005
Contact: Jing Liu, M.D.    86+1366-6025-46    magiejing@163.com   
Sponsors and Collaborators
Xiamen University
  More Information

No publications provided

Responsible Party: Zuguo Liu, Dean of Xiamen University Medical School, Xiamen University
ClinicalTrials.gov Identifier: NCT01443559     History of Changes
Other Study ID Numbers: EIXM-XKFPC-20110901
Study First Received: September 19, 2011
Last Updated: September 29, 2011
Health Authority: China: Ethics Committee

Keywords provided by Xiamen University:
Xenogenic

ClinicalTrials.gov processed this record on October 19, 2014