Corneal Cross Linking and Topography Guided Excimer Laser Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gerald Schmidinger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01682993
First received: November 5, 2011
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Keratoconus
Pellucid Marginal Degeneration
Other: Topography guided Excimer Laser treatment and Corneal Cross Linking
Other: Corneal Cross Linking
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Safety (Pachymetry, K-readings) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • uncorrected visual acuity (UVCA) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • best corrected visual acuity (BCVA) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression of ectatic disease (by use of maximum keratometry readings = Kmax) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682993

Locations
Austria
Medical University of Vienna, Department of Ophthalmology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerald Schmidinger, MD, Assistant Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01682993     History of Changes
Other Study ID Numbers: 367/2009
Study First Received: November 5, 2011
Last Updated: December 4, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
corneal cross linking
topography guided excimer laser
Keratoconus
Pellucid marginal degeneration
Post Excimer ectasia

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014