Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty
Phase 2
Terminated
- Conditions
- Penetrating Keratoplasty
- Registration Number
- NCT00463723
- Lead Sponsor
- University Hospital Freiburg
- Brief Summary
Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Penetrating keratoplasty for Keratoconus
- Penetrating keratoplasty for Fuchs endothelial dystrophie
- Penetrating keratoplasty for Bullous keratopathy
Exclusion Criteria
- Glaucoma
- Limbal stem cell deficiency
- Herpetic eye disease
- Repeat Keratoplasty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method