Status:
COMPLETED
Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
Lead Sponsor:
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborating Sponsors:
Linkoeping University
Conditions:
Corneal Ulcer
Leukoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this study the safety and effectiveness of biosynthetic cornea, comprising interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested in patients with severe corn...
Detailed Description
Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using anterior lamellar kera...
Eligibility Criteria
Inclusion
- Subjects must sign and be given a copy of the written Informed Consent form.
- Subjects with best corrected distance visual acuity 20/200 or worse as a result of corneal ulcer or corneal scar due to burn, injury or infection in the operative eye.
- Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.
Exclusion
- Subjects with severe or life-threatening systemic disease.
- Subjects with uncontrolled hypertension.
- Subjects with uncontrolled diabetes or insulin-dependent diabetes.
- Subjects with glaucoma in either eye.
- Subjects with marked microphthalmos or aniridia in either eye.
- Subjects with any other serious ocular pathology, serious ocular complications at the time of corneal transplant underlying serious medical conditions, based on the investigator's medical judgment.
- Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02277054
Start Date
March 1 2013
End Date
January 1 2017
Last Update
October 26 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine, 65061