The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%.
- Conditions
- Penetrating keratoplasty (PKP)
- Registration Number
- JPRN-UMIN000029669
- Lead Sponsor
- Tokyo Dental Collage Ichikawa General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Patients with allergic history against tavrolimus ophthalmic susupension 2) Patients with infectious eye disease 3) Patients with allergic history against betamethasone or fluorometholone ey drop 4) Diabetic patients with poor glycemic control 5) Glaucoma patients with poor IOP control 6) Patients with severe infectious disease 7) Patients with limbal transplantation 8) Patients with cancer, severe liver dysfunction, severe renal dysfunction, severe cardiac disease, and other severe conditions 9) Pregnant women, lactating women, may possibly be pregnant women 10) Patients whom the prior treatment with topical or systemic use of steroid or immunosuppressant within 4 week before initiation 11) Patients whom are expected to need a contraindicated durg use or therapy in the study period 12) Patients whom are considered unsuitable by doctor in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rejection rates of the graft on week 52 post-operatively.
- Secondary Outcome Measures
Name Time Method 1) Survival rates of the graft on week 52 post-operatively "2) Survival rates of the graft on week 26, 52 and last observation post-operatively 3) Adverse drug reactions on week 26, 52 and last observation post-operatively 4) Best corrected visual acuity 5) Corneal endthelial cell density 6) Influenced factors to survival rate of the graft on week 52 post-operatively 7) Survival rates of the graft when adjustment of influence factors 8) Recruitment of dendritic cell and reconstitution of trigerminal"