Corneal Cross Linking and Topography Guided Excimer Laser Treatment

Phase 3

Terminated

• Conditions: Keratoconus; Pellucid Marginal Degeneration
• Interventions: Other: Corneal Cross Linking; Other: Topography guided Excimer Laser treatment and Corneal Cross Linking

• Registration Number: NCT01682993
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-11-05
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal Cross Linking	Corneal Cross Linking	Patients will receive a standard corneal cross linking treatment
Corneal Cross Linking and Topo Laser	Topography guided Excimer Laser treatment and Corneal Cross Linking	Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.

Primary Outcome Measures

Name	Time	Method
Safety (Pachymetry, K-readings)	1 year
uncorrected visual acuity (UVCA)	1 year
best corrected visual acuity (BCVA)	1 year

Secondary Outcome Measures

Name	Time	Method
Progression of ectatic disease (by use of maximum keratometry readings = Kmax)	1 year

Trial Locations

Locations (1)

Medical University of Vienna, Department of Ophthalmology; 🇦🇹 Vienna, Austria