- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682993
Corneal Cross Linking and Topography Guided Excimer Laser Treatment
Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna, Department of Ophthalmology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Corneal Cross Linking
Patients will receive a standard corneal cross linking treatment
|
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.
|
A topography guided excimer laser treatment will be performed prior to CCL in one session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety (Pachymetry, K-readings)
Time Frame: 1 year
|
1 year
|
uncorrected visual acuity (UVCA)
Time Frame: 1 year
|
1 year
|
best corrected visual acuity (BCVA)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 367/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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