Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450996
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2007-03-20
Brief Title:
Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Phase 3 Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None