Corneal Cross Linking and Topography Guided Excimer Laser Treatment

NCT ID: NCT01682993

Last Updated: 2017-04-26

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-12-31

Brief Summary

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Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.

This randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.

Detailed Description

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Conditions

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Keratoconus Pellucid Marginal Degeneration

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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Corneal Cross Linking

Patients will receive a standard corneal cross linking treatment

Group Type ACTIVE_COMPARATOR

Corneal Cross Linking

Intervention Type OTHER

A standard corneal cross linking procedure will be performed in this arm.

Corneal Cross Linking and Topo Laser

Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.

Group Type EXPERIMENTAL

Topography guided Excimer Laser treatment and Corneal Cross Linking

Intervention Type OTHER

A topography guided excimer laser treatment will be performed prior to CCL in one session.

Interventions

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Topography guided Excimer Laser treatment and Corneal Cross Linking

A topography guided excimer laser treatment will be performed prior to CCL in one session.

Intervention Type OTHER

Corneal Cross Linking

A standard corneal cross linking procedure will be performed in this arm.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Patient age 18 - 40 years
* Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia

Exclusion Criteria

* Allergy to one of the used substances
* Tendency towards excessive scar formation
* Pregnancy
* Rheumatic diseases
* Central corneal thickness below 450 µm
* Active infection of the study eye
* Previous corneal surgery of the study eye
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerald Schmidinger

MD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna, Department of Ophthalmology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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367/2009

Identifier Type: -

Identifier Source: org_study_id

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