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

NCT00450996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-06-04

No results posted yet for this study

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).

Conditions

  • Graft Rejection

Interventions

DRUG

Topical Steroids

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • friedrich Naumann, MD · University of Erlangen-Nürnberg

  • claus Cursiefen, md · University of Erlangen-Nürnberg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Completion
2007-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00450996 on ClinicalTrials.gov