Immunosuppression After Repeat Keratoplasty

Study Overview
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Brief Summary
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Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty. Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed. Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12

Official Title
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Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial

Conditions
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Keratopathy

Intervention / Treatment
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* Drug: prescribe topical 0.03 % tacrolimus
* Drug: prescribe mycophenolate mofetil(MMF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK ) Exclusion Criteria: uncontrolled increase in intraocular pressure active herpetic keratitis and corneal ulcer limbal stem cell deficiency a history of limbal stem cell transplantation age less than 18 years pregnancy, a history of malignant disorders abnormal liver or kidney function the presence of poorly controlled systemic hypertension diabetes mellitus systemic infections active peptic ulcer disease any gastrointestinal disorders led to patient exclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usage mycophenolate mofetil<br> | Drug: prescribe mycophenolate mofetil(MMF)<br>* MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months<br>|
| Active Comparator: usage tacrolimus<br> | Drug: prescribe topical 0.03 % tacrolimus<br>* prescribe topical 0.03 % tacrolimus 3 times a day for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft rejection | clinical examination | 12 months |