Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-Risk Penetrating Keratoplasty

This study has been completed.
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00450996
First received: March 20, 2007
Last updated: October 16, 2008
Last verified: October 2008
  Purpose

PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 >= 19 years; follow-up: 42 >= 18months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months).


Condition Intervention
Graft Rejection
Drug: Topical Steroids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 3: Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-Risk Penetrating Keratoplasty

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Graft survival

Estimated Enrollment: 400
Study Start Date: January 1999
Study Completion Date: March 2007
Detailed Description:

PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 >= 19 years; follow-up: 42 >= 18 months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months). <=

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low risk keratoplasty

Exclusion Criteria:

  • High risk keratoplasty
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00450996

Sponsors and Collaborators
University of Erlangen-Nürnberg
Investigators
Principal Investigator: friedrich Naumann, MD University of Erlangen-Nürnberg
Study Director: claus Cursiefen, md University of Erlangen-Nürnberg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00450996     History of Changes
Other Study ID Numbers: PostkeratoplastySteroids
Study First Received: March 20, 2007
Last Updated: October 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 22, 2014