Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial
Sponsor study identifier
interventional
58
1 country
1
Study Start
November 2019
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Primary Completion
March 2020
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Study Completion
August 2020
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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
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August 2020
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October 30, 2019
Actual (reported)November 2019
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November 1, 2019
Actual (reported)March 2020
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August 2020
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graft rejection
clinical examination
12 months
prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months
Ophthalmic Research Center
Tehran, Iran
First Submitted
October 30, 2019
First Posted
November 1, 2019
Study Start
November 2019
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Primary Completion
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March 2020
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Study Completion
August 2020
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Last Updated
November 1, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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