Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

Not Applicable

Completed

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 corneal pathology (corneal ulcers or corneal opacification from corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the only widely accepted treatment) carries a high risk of rejection.

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 keratoplasty technique, i.e. when patient's diseased cornea is removed it will be substituted with proposed transparent implant. Usually these patients are grafted with human donor cornea, but the latter frequently fails due to graft-versus-host problems. We will test the safety (incidence of adverse events, biocompatability) and the effectiveness (ability to promote healing and increase vision) of developed biosynthetic corneas in 10 patients with corneal pathology, where human donor cornea carries a high risk of rejection. The patients will be follow-uped for 12 months.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Collagen-MPC cornea substitute	Collagen-MPC cornea	Collagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	12 months	Implant safety and tolerability will be measured by absence/presence of its lysis as well as by degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Healed Cornea at 12 Months	12 months	Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface
Number of Participants With Improved Visual Acuity at 12 Months	12 months	Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity