Corneal Cross Linking and Topography Guided Excimer Laser Treatment
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.
|Keratoconus Pellucid Marginal Degeneration||Other: Topography guided Excimer Laser treatment and Corneal Cross Linking Other: Corneal Cross Linking||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.|
- Safety (Pachymetry, K-readings) [ Time Frame: 1 year ]
- uncorrected visual acuity (UVCA) [ Time Frame: 1 year ]
- best corrected visual acuity (BCVA) [ Time Frame: 1 year ]
- Progression of ectatic disease (by use of maximum keratometry readings = Kmax) [ Time Frame: 1 year ]
|Study Start Date:||January 2010|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Corneal Cross Linking
Patients will receive a standard corneal cross linking treatment
Other: Corneal Cross Linking
A standard corneal cross linking procedure will be performed in this arm.
Experimental: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682993
|Medical University of Vienna, Department of Ophthalmology|
|Vienna, Austria, 1090|