Working… Menu
Trial record 1 of 2 for:    "Bullous Keratopathy" | "Dipivefrin"
Previous Study | Return to List | Next Study

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. Identifier: NCT01682421
Recruitment Status : Withdrawn
First Posted : September 11, 2012
Last Update Posted : May 2, 2014
Information provided by (Responsible Party):
Anders Ivarsen, Aarhus University Hospital

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.

Condition or disease Intervention/treatment Phase
Endothelial Dystrophy Secondary Bullous Keratopathy Posterior Lamellar Keratoplasty Descemet's Stripping Endothelial Keratoplasty Drug: Weak steroid (Flurolon, Allergan) Drug: Potent steroid (Maxidex, Alcon) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation
Study Start Date : September 2012
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Freedom from rejection [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682421

Layout table for location information
Department of Ophthalmology, Aarhus Universtity Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
Aarhus University Hospital

Layout table for additonal information
Responsible Party: Anders Ivarsen, MD, PhD, Aarhus University Hospital Identifier: NCT01682421     History of Changes
Other Study ID Numbers: AUH_DSAEK_STEROID
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Dexamethasone acetate
BB 1101
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors