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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01682993

Enrollment

Registered

2012-09-11

Start date

2010-01-31

Completion date

2015-12-31

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus, Pellucid Marginal Degeneration

Keywords

corneal cross linking, topography guided excimer laser, Keratoconus, Pellucid marginal degeneration, Post Excimer ectasia

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.

Interventions

OTHERTopography guided Excimer Laser treatment and Corneal Cross Linking

A topography guided excimer laser treatment will be performed prior to CCL in one session.

OTHERCorneal Cross Linking

A standard corneal cross linking procedure will be performed in this arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety (Pachymetry, K-readings)	1 year
uncorrected visual acuity (UVCA)	1 year
best corrected visual acuity (BCVA)	1 year

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026