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

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ClinicalTrials.gov Identifier: NCT00450996
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
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 or disease Intervention/treatment Phase
Graft Rejection Drug: Topical Steroids Not Applicable

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). <=

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
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
Study Start Date : January 1999
Actual Study Completion Date : March 2007



Primary Outcome Measures :
  1. Graft survival


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

Inclusion Criteria:

  • Low risk keratoplasty

Exclusion Criteria:

  • High risk keratoplasty

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

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