Corneal Cross Linking and Topography Guided Excimer Laser Treatment

Keratoconus Clinical Trial

Official title:

Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01682993
• Other study ID #: 367/2009
• Status: Terminated
• Phase: Phase 3
• First received: November 5, 2011
• Last updated: April 25, 2017
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus
• Pellucid Marginal Degeneration

Intervention

Other:
• Topography guided Excimer Laser treatment and Corneal Cross Linking
A topography guided excimer laser treatment will be performed prior to CCL in one session.
• Corneal Cross Linking
A standard corneal cross linking procedure will be performed in this arm.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Ophthalmology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Pachymetry, K-readings)		1 year
Primary	uncorrected visual acuity (UVCA)		1 year
Primary	best corrected visual acuity (BCVA)		1 year
Secondary	Progression of ectatic disease (by use of maximum keratometry readings = Kmax)		1 year