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Corneal Cross Linking and Topography Guided Excimer Laser Treatment

Primary Purpose

Keratoconus, Pellucid Marginal Degeneration

Status
Terminated
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Topography guided Excimer Laser treatment and Corneal Cross Linking
Corneal Cross Linking
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring corneal cross linking, topography guided excimer laser, Keratoconus, Pellucid marginal degeneration, Post Excimer ectasia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Vienna, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corneal Cross Linking

Corneal Cross Linking and Topo Laser

Arm Description

Patients will receive a standard corneal cross linking treatment

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

Outcomes

Primary Outcome Measures

Safety (Pachymetry, K-readings)
uncorrected visual acuity (UVCA)
best corrected visual acuity (BCVA)

Secondary Outcome Measures

Progression of ectatic disease (by use of maximum keratometry readings = Kmax)

Full Information

First Posted
November 5, 2011
Last Updated
April 25, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01682993
Brief Title
Corneal Cross Linking and Topography Guided Excimer Laser Treatment
Official Title
Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Pellucid Marginal Degeneration
Keywords
corneal cross linking, topography guided excimer laser, Keratoconus, Pellucid marginal degeneration, Post Excimer ectasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corneal Cross Linking
Arm Type
Active Comparator
Arm Description
Patients will receive a standard corneal cross linking treatment
Arm Title
Corneal Cross Linking and Topo Laser
Arm Type
Experimental
Arm Description
Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.
Intervention Type
Other
Intervention Name(s)
Topography guided Excimer Laser treatment and Corneal Cross Linking
Intervention Description
A topography guided excimer laser treatment will be performed prior to CCL in one session.
Intervention Type
Other
Intervention Name(s)
Corneal Cross Linking
Intervention Description
A standard corneal cross linking procedure will be performed in this arm.
Primary Outcome Measure Information:
Title
Safety (Pachymetry, K-readings)
Time Frame
1 year
Title
uncorrected visual acuity (UVCA)
Time Frame
1 year
Title
best corrected visual acuity (BCVA)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression of ectatic disease (by use of maximum keratometry readings = Kmax)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical University of Vienna, Department of Ophthalmology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Corneal Cross Linking and Topography Guided Excimer Laser Treatment

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