Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

Not Applicable

Withdrawn

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

• Registration Number: NCT01682421
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weak steroid	Weak steroid (Flurolon, Allergan)	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.
Potent steroid	Potent steroid (Maxidex, Alcon)	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.

Primary Outcome Measures

Name	Time	Method
Freedom from rejection	2 years

Trial Locations

Locations (1)

Department of Ophthalmology, Aarhus Universtity Hospital; 🇩🇰 Aarhus, Denmark