Analysis of a Beneficial Effect of Prolonges Topical Ster... | NCT00450996

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

NCT00450996

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Jun 4, 2015Estimated

Enrollment

400

Phase

Not Applicable

Conditions

Graft Rejection

Interventions

Topical Steroids

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Mar 20, 2007

First Submission Date that Met QC Criteria

Mar 20, 2007

First Posted Date

Mar 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2015

Last Update Posted Date

Jun 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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). <=

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
Topical Steroids	Drug

Measure	Description	Time Frame
Graft survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low risk keratoplasty

Exclusion Criteria:

High risk keratoplasty

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
friedrich Naumann, MD	University of Erlangen-Nürnberg	Principal Investigator
claus Cursiefen, md	University of Erlangen-Nürnberg	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013256	Steroids

Ancestor Terms

ID	Term
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

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Browse Branches

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