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Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

This study is currently recruiting participants.
Verified September 2012 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Anders Ivarsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01682421
First received: September 4, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Endothelial Dystrophy
Secondary Bullous Keratopathy
Posterior Lamellar Keratoplasty
Descemet's Stripping Endothelial Keratoplasty
 Drug: Weak steroid (Flurolon, Allergan)
Drug: Potent steroid (Maxidex, Alcon)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Freedom from rejection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: September 2012
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Weak steroid (Flurolon, Allergan)
Other Name: 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.
 Drug: Potent steroid (Maxidex, Alcon)
Other Name: Maxidex, Alcon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682421

Contacts
Contact: Anders Ivarsen, MD, PhD ai@dadlnet.dk

Locations
Denmark
Department of Ophthalmology, Aarhus Universtity Hospital Recruiting
Aarhus, Denmark, DK-8000
Contact: Anders Ivarsen, MD, PhD         ai@dadlnet.dk    
Principal Investigator: Anders Ivarsen, MD, PhD            
Sponsors and Collaborators
Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Anders Ivarsen, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01682421     History of Changes
Other Study ID Numbers: AUH_DSAEK_STEROID
Study First Received: September 4, 2012
Last Updated: September 10, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Corneal Edema
Corneal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013