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Corneal Cross Linking and Topography Guided Excimer Laser Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682993
Recruitment Status : Terminated
First Posted : September 11, 2012
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Gerald Schmidinger, 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.
Study Start Date : January 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Safety (Pachymetry, K-readings) [ Time Frame: 1 year ]
  2. uncorrected visual acuity (UVCA) [ Time Frame: 1 year ]
  3. best corrected visual acuity (BCVA) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Progression of ectatic disease (by use of maximum keratometry readings = Kmax) [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01682993

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Medical University of Vienna, Department of Ophthalmology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Responsible Party: Gerald Schmidinger, MD, Assistant Professor, Medical University of Vienna Identifier: NCT01682993    
Other Study ID Numbers: 367/2009
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Gerald Schmidinger, Medical University of Vienna:
corneal cross linking
topography guided excimer laser
Pellucid marginal degeneration
Post Excimer ectasia
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases