Immunosuppression After Repeat Keratoplasty

Phase 2

• Conditions: Keratopathy
• Interventions: Drug: prescribe mycophenolate mofetil(MMF); Drug: prescribe topical 0.03 % tacrolimus

• Registration Number: NCT04147390
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Study Start: 2019-11
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-01
• Primary Completion: 2020-03
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usage mycophenolate mofetil	prescribe mycophenolate mofetil(MMF)	-
usage tacrolimus	prescribe topical 0.03 % tacrolimus	-

Primary Outcome Measures

Name	Time	Method
graft rejection	12 months	clinical examination

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of