Corneal Cross Linking and Topography Guided Excimer Laser Treatment

Medical University of Vienna

Status and phase: Terminated; Phase 3

Conditions: Keratoconus; Pellucid Marginal Degeneration

Treatments: Other: Topography guided Excimer Laser treatment and Corneal Cross Linking; Other: Corneal Cross Linking

Study type: Interventional

Funder types: Other

Identifiers

NCT01682993

367/2009

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Corneal Cross Linking

Active Comparator group

Description:

Patients will receive a standard corneal cross linking treatment

Treatment:

Other: Corneal Cross Linking

Corneal Cross Linking and Topo Laser

Experimental group

Description:

Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.

Treatment:

Other: Topography guided Excimer Laser treatment and Corneal Cross Linking