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Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01682421
Recruitment Status : Withdrawn
First Posted : September 11, 2012
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Anders Ivarsen, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
Freedom from rejection [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01682421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation
Official Title  ICMJE Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation
Brief Summary

After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.

However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.

Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.

The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endothelial Dystrophy
  • Secondary Bullous Keratopathy
  • Posterior Lamellar Keratoplasty
  • Descemet's Stripping Endothelial Keratoplasty
Intervention  ICMJE
  • Drug: Weak steroid (Flurolon, Allergan)
    Other Name: Flurolon, Allergan
  • Drug: Potent steroid (Maxidex, Alcon)
    Other Name: Maxidex, Alcon
Study Arms  ICMJE
  • Experimental: Weak steroid
    Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and finally 1x per day continually during 2 years.
    Intervention: Drug: Weak steroid (Flurolon, Allergan)
  • Experimental: Potent steroid
    Initially Dexamethasone 6x per day for 2 weeks followed by 4x per day for one month, 3x per day for one month, 2x per day for one month, and finally 1x per day for one month - giving a total of 4,5 months of steroid treatment.
    Intervention: Drug: Potent steroid (Maxidex, Alcon)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 30, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2012)
350
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients treated for primary or secondary corneal endothelial failure at the department of ophthalmology, Aarhus University Hospital

Exclusion Criteria:

  • Not fulfilling the above
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682421
Other Study ID Numbers  ICMJE AUH_DSAEK_STEROID
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anders Ivarsen, Aarhus University Hospital
Study Sponsor  ICMJE Aarhus University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aarhus University Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP