Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02277054
Study type Interventional
Source The Filatov Institute of Eye Diseases and Tissue Therapy
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date January 2017

See also
  Status Clinical Trial Phase
Recruiting NCT05705024 - Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells Phase 2
Completed NCT02731638 - Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers Phase 3
Completed NCT00324168 - Steroids for Corneal Ulcers Trial Phase 4
Completed NCT04484402 - Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells Phase 1/Phase 2
Completed NCT04820010 - Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Recruiting NCT02570321 - Cross-linking for Corneal Ulcers Treatment Trial Phase 4
Completed NCT00386958 - A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers Phase 2
Completed NCT04054817 - ACRO Biocornea Clinical Trial in Taiwan N/A
Completed NCT00997035 - The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo Phase 3
Recruiting NCT05313828 - Effect of Various Treatment Modalities on Dendritic Vial Ulcer
Recruiting NCT05255016 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory Corneal Ulcers Phase 2/Phase 3
Recruiting NCT05255107 - Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers Phase 2/Phase 3
Completed NCT05891106 - AONDA Therapeutic Indication Study I
Terminated NCT00789646 - Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients N/A
Not yet recruiting NCT05940376 - Topical Insulin in Neurotrophic Keratopathy After Diabetic Vitrectomy
Completed NCT05200000 - Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis Phase 1
Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Active, not recruiting NCT01969786 - Village Integrated Eye Workers Trial N/A
Completed NCT01794312 - Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer Phase 3
Completed NCT04837534 - Improving the Follow up Rate for Pediatric Patients N/A