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

Phase 3: Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00450996
Enrollment
400
Registered
2007-03-22
Start date
1999-01-31
Completion date
2007-03-31
Last updated
2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Rejection

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). \<=

Interventions

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Low risk keratoplasty

Exclusion criteria

* High risk keratoplasty

Design outcomes

Primary

MeasureTime frame
Graft survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026