CClinicalTrials.gg
CompletedNCT00450996Updated Jun 4, 2015

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

An interventional study of Topical Steroids in Graft Rejection, sponsored by University of Erlangen-Nürnberg Medical School. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-04.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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).

Read the 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). \<=

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Conditions studied

  • Graft Rejection
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In context

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Low risk keratoplasty

Exclusion criteria

Exclusion Criteria:

  • High risk keratoplasty
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants

Interventions

  • DrugTopical Steroids
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What researchers measure

Primary outcomes

  1. Graft survival

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00450996
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Mar 22, 2007
Start date
Jan 1999
Completion
Mar 2007
Last update
Jun 4, 2015

Study contacts

friedrich Naumann, MD
principal investigator · University of Erlangen-Nürnberg
claus Cursiefen, md
study director · University of Erlangen-Nürnberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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