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Immunosuppression After Repeat Keratoplasty

S

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Keratopathy

Treatments

Drug: prescribe mycophenolate mofetil(MMF)
Drug: prescribe topical 0.03 % tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

58 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups

usage mycophenolate mofetil
Active Comparator group
Treatment:
Drug: prescribe mycophenolate mofetil(MMF)
usage tacrolimus
Active Comparator group
Treatment:
Drug: prescribe topical 0.03 % tacrolimus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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