NCT01682993

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

5.9 years

First QC Date

November 5, 2011

Last Update Submit

April 25, 2017

Conditions

KeratoconusPellucid Marginal Degeneration

Keywords

corneal cross linkingtopography guided excimer laserKeratoconusPellucid marginal degenerationPost Excimer ectasia

Outcome Measures

Primary Outcomes (3)

  • Safety (Pachymetry, K-readings)

    1 year

  • uncorrected visual acuity (UVCA)

    1 year

  • best corrected visual acuity (BCVA)

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

Corneal Cross Linking

ACTIVE COMPARATOR

Patients will receive a standard corneal cross linking treatment

Other: Corneal Cross Linking

Corneal Cross Linking and Topo Laser

EXPERIMENTAL

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

Other: Topography guided Excimer Laser treatment and Corneal Cross Linking

Interventions

Topography guided Excimer Laser treatment and Corneal Cross LinkingOTHER

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

Corneal Cross Linking and Topo Laser
Corneal Cross LinkingOTHER

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

Corneal Cross Linking

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent
  • Patient age 18 - 40 years
  • Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

November 5, 2011

First Posted

September 11, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

AU(1)