Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation
|ClinicalTrials.gov Identifier: NCT01682421|
Recruitment Status : Withdrawn
First Posted : September 11, 2012
Last Update Posted : May 2, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2012|
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
- Freedom from rejection [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682421
|Department of Ophthalmology, Aarhus Universtity Hospital|
|Aarhus, Denmark, DK-8000|