Overview

This trial is active, not recruiting.

Conditions keratoconus, pellucid marginal degeneration
Treatments topography guided excimer laser treatment and corneal cross linking, corneal cross linking
Phase phase 3
Sponsor Medical University of Vienna
Start date January 2010
End date December 2014
Trial size 40 participants
Trial identifier NCT01682993, 367/2009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients will receive a standard corneal cross linking treatment
corneal cross linking
A standard corneal cross linking procedure will be performed in this arm.
(Experimental)
Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.
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 Outcomes

Measure
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

Secondary Outcomes

Measure
Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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

Additional Information

Official title Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Medical University of Vienna.