N/A
N=5
Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
Corneal Ulcer · Leukoma
Bottom Line
View on ClinicalTrials.gov: NCT02277054 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Incidence of Treatment-Emergent Adverse Events — 0 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Collagen-MPC cornea (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Filatov Institute of Eye Diseases and Tissue Therapy
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
— | — |
| SECONDARY Number of Participants With Healed Cornea at 12 Months |
5 | — |
| SECONDARY Number of Participants With Improved Visual Acuity at 12 Months |
3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02277054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.