NCT00450996

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

First QC Date

March 20, 2007

Last Update Submit

June 3, 2015

Conditions

Graft Rejection

Outcome Measures

Primary Outcomes (1)

  • Graft survival

Interventions

Topical SteroidsDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low risk keratoplasty

You may not qualify if:

  • High risk keratoplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Steroids

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • friedrich Naumann, MD

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

  • claus Cursiefen, md

    University of Erlangen-Nürnberg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

January 1, 1999

Study Completion

March 1, 2007

Last Updated

June 4, 2015

Record last verified: 2015-06