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Immunosuppression After Repeat Keratoplasty

NCT04147390 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-11-01

No results posted yet for this study

Summary

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

Conditions

  • Keratopathy

Interventions

DRUG

prescribe topical 0.03 % tacrolimus

prescribe topical 0.03 % tacrolimus 3 times a day for 12 months

DRUG

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

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-03-31
Completion
2020-08-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147390 on ClinicalTrials.gov