Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

NCT ID: NCT01682421

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Weak steroid (Flurolon, Allergan)

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Potent steroid (Maxidex, Alcon)

Intervention Type DRUG

Interventions

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Weak steroid (Flurolon, Allergan)

Intervention Type DRUG

Potent steroid (Maxidex, Alcon)

Intervention Type DRUG

Other Intervention Names

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Flurolon, Allergan Maxidex, Alcon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Ivarsen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Ophthalmology, Aarhus Universtity Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AUH_DSAEK_STEROID

Identifier Type: -

Identifier Source: org_study_id

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