Immunosuppression After Repeat Keratoplasty

Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04147390

Enrollment

Registered

2019-11-01

Start date

2019-11-30

Completion date

2020-08-31

Last updated

2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratopathy

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

Interventions

DRUGprescribe topical 0.03 % tacrolimus

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

DRUGprescribe mycophenolate mofetil(MMF)

MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
graft rejection	12 months	clinical examination

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026