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

March 20, 2007
October 16, 2008
January 1999
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Graft survival
Same as current
Complete list of historical versions of study NCT00450996 on ClinicalTrials.gov Archive Site
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Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-Risk Penetrating Keratoplasty
Phase 3: Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-Risk Penetrating Keratoplasty

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).

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). <=

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Graft Rejection
Drug: Topical Steroids
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
March 2007
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Inclusion Criteria:

  • Low risk keratoplasty

Exclusion Criteria:

  • High risk keratoplasty
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00450996
PostkeratoplastySteroids
No
Not Provided
University of Erlangen-Nürnberg
Not Provided
Principal Investigator: friedrich Naumann, MD University of Erlangen-Nürnberg
Study Director: claus Cursiefen, md University of Erlangen-Nürnberg
University of Erlangen-Nürnberg Medical School
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP