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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450996
First Posted: March 22, 2007
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low risk keratoplasty

Exclusion Criteria:

  • High risk keratoplasty
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450996


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

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00450996     History of Changes
Other Study ID Numbers: PostkeratoplastySteroids
First Submitted: March 20, 2007
First Posted: March 22, 2007
Last Update Posted: June 4, 2015
Last Verified: June 2015