Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
58 participants
INTERVENTIONAL
2019-11-30
2020-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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usage mycophenolate mofetil
prescribe mycophenolate mofetil(MMF)
MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months
usage tacrolimus
prescribe topical 0.03 % tacrolimus
prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
Interventions
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prescribe topical 0.03 % tacrolimus
prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
prescribe mycophenolate mofetil(MMF)
MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of ophthalmic research center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Facility Contacts
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Other Identifiers
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96340
Identifier Type: -
Identifier Source: org_study_id
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