Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial
prescribe topical 0.03 % tacrolimus
+ prescribe mycophenolate mofetil(MMF)
Prevention Study
Summary
Study start date: November 1, 2019
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.58 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location