The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%
- Conditions
- Penetrating keratoplastyKeratoplasty, Penetrating
- Registration Number
- JPRN-jRCTs031180342
- Lead Sponsor
- Shimazaki Jun
- Brief Summary
Brief summaryIn the present study, although no significant adverse event was occurred during 52-week administration of 0.1% tacrolimus ophthalmic solution for patients undergoing penetrating keratoplasty, it was not possible to clarify the rejection-suppressing effect of 0.1% tacrolimus ophthalmic solution in the scheduled observation period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Patients with PKP who are relevant the following conditions
1) Patients with the history of PKP
2) Patients with the history of rejection
3) Patients with vascuralization in corneal stroma (more than half)
4) Atopic patients with keratoconus
1) Patients with allergic history against tacrolimus ophthalmic suspension
2) Patients with infectious eye disease
3) Patients with allergic history against betamethasone or fluorometholone eye drop
4) Patients with corneal erosion or corneal ulcer
5) Patients with viral corneal and conjunctival disease, tuberculous eye disease, fungal eye disease, or purulent eye disease
6) Diabetic patients with poor glycemic control
7) Glaucoma patients with poor IOP control
8) Patients with severe infectious disease
9) Patients with limbal transplantation
10) Patients with cancer, severe liver dysfunction, severe renal dysfunction, severe cardiac disease, and other severe conditions
11) Pregnant women, lactating women, may possibly be pregnant women
12) Patients whom the prior treatment with topical or systemic use of steroid or immunosuppressant within 4 week before initiation
13) Patients whom are expected to need a contraindicated drug use or therapy in the study period
14) 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<br>2) Survival rates of the graft on week 26, 52 and last observation post-operatively<br>3) Adverse drug reactions on week 26, 52 and last observation post-operatively<br>4) Best corrected visual acuity<br>5) Corneal endothelial cell density<br>6) Influenced factors to survival rate of the graft on week 52 post-operatively<br>7) Survival rates of the graft when adjustment of influence factors<br>8) Recruitment of dendritic cell and reconstitution of trigerminal nerve