Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

Aarhus University Hospital

Status: Withdrawn

Conditions: Posterior Lamellar Keratoplasty; Endothelial Dystrophy; Secondary Bullous Keratopathy; Descemet's Stripping Endothelial Keratoplasty

Treatments: Drug: Weak steroid (Flurolon, Allergan); Drug: Potent steroid (Maxidex, Alcon)

Study type: Interventional

Funder types: Other

Identifiers

NCT01682421

AUH_DSAEK_STEROID

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Weak steroid

Experimental group

Description:

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.

Treatment:

Drug: Weak steroid (Flurolon, Allergan)

Potent steroid

Experimental group

Description:

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.

Treatment:

Drug: Potent steroid (Maxidex, Alcon)