Status:
SUSPENDED
Xenogenic Keratoplasty From Porcine Cornea
Lead Sponsor:
Xiamen University
Conditions:
Porcine Corneal Xenograph
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01443559
Start Date
September 1 2011
End Date
December 1 2015
Last Update
July 17 2015
Active Locations (1)
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1
Xiamen University Affiliated Xiamen Eye Center
Xiamen, Fujian, China, 361005