Corneal Cross Linking and Topography Guided Excimer Laser Treatment
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|ClinicalTrials.gov Identifier: NCT01682993|
Recruitment Status : Terminated
First Posted : September 11, 2012
Last Update Posted : April 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus Pellucid Marginal Degeneration||Other: Topography guided Excimer Laser treatment and Corneal Cross Linking Other: Corneal Cross Linking||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682993
|Medical University of Vienna, Department of Ophthalmology|
|Vienna, Austria, 1090|