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Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.

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What is being tested

Corneal Cross Linking

+ Topography guided Excimer Laser treatment and Corneal Cross Linking

Other
Who is being recruted

Corneal Diseases

+ Eye Diseases

+ Keratoconus

From 18 to 40 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorMedical University of Vienna
Last updated: April 26, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01682993
Principal SponsorMedical University of Vienna
Last updated: April 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Corneal DiseasesEye DiseasesKeratoconus

Criteria

3 inclusion criteria required to participate
Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia
Patient age 18 - 40 years
Signed informed consent
7 exclusion criteria prevent from participating
Active infection of the study eye
Allergy to one of the used substances
Central corneal thickness below 450 μm
Pregnancy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients will receive a standard corneal cross linking treatment

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of Vienna, Department of Ophthalmology

Vienna, AustriaOpen Medical University of Vienna, Department of Ophthalmology in Google Maps
SuspendedOne Study Center