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

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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). RESULTS: During follow-up, 29 eyes (7.1%) developed an episode of endothelial graft rejection. Graft rejections were significantly more common in the short-term (19 of 202; 9.1%) compared to the long-term treatment group (10 of 204: 4.9%; p=0.001). CONCLUSIONS: Long-term low-dose topical steroid treatment protects against immunological graft rejections.

Condition	Intervention
Graft Rejection	Drug: Topical Steroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

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:

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). RESULTS: During follow-up, 29 eyes (7.1%) developed an episode of endothelial graft rejection. Graft rejections were significantly more common in the short-term (19 of 202; 9.1%) compared to the long-term treatment group (10 of 204: 4.9%; p=0.001). CONCLUSIONS: Long-term low-dose topical steroid treatment protects against immunological graft rejections.

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

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

Study Director:	claus Cursiefen, md	University of Erlangen

More Information

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

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	University of Erlangen-Nürnberg
Information provided by:	University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:	NCT00450996