Evaluating Collagen Cross-Linking (CCL) Treatment in Norway - Tabular View

Tracking Information

First Received Date ^ICMJE

February 13, 2007

Last Updated Date

June 9, 2008

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

1 Efficacy will be evaluated based on: a. reduction of keratometry (curvature) values, b. improvement in distance best spectacle corrected visual acuity (BSCVA) and c. improvement in patients visual disturbances.
2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).
3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00435799 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

Official Title ^ICMJE

Treatment of Keratectasia With Collagen Cross-Linking (CCL) at the Eye Departments of the University Hospital, North Norway in Tromsø and Ullevål University Hospital in Oslo

Brief Summary

The purpose of this study is to assess safety, efficacy and stability of riboflavin-UV induced cross-linking of corneal collagen in reducing the progression of keratecatasia and in improving visual acuity. This is the first Norwegian study concerning CCL.

Detailed Description

The technique of corneal collagen cross-linking consists of photopolymerization of stromal fibers by combined action of a photosensitizing substance, riboflavin and ultraviolet type A rays (UVA) from a solid-state UVA Source. Photopolymerization increases the rigidity of corneal collagen and its resistance to keratectasia. It has been used to stop progression of keratectasia.

Corneal transplantation has been the only available option so far for treatment for keratectasia in its advanced stage in Norway. The method of CCL using riboflavin and UV light is technically simple and much less invasive than corneal transplantation and it treats and prevents the underlying pathophysiological mechanism. It also does not reduce the chances for a successful corneal transplantation, in case that would still be necessary after CCL.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Keratoconus

Intervention ^ICMJE

Procedure: corneal cross-linking (CCL)
Drug: Riboflavin/dextran eyedrops
Device: UV-X system

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age from 20 to 45 years
Progressive keratectasia (primary or secondary) in an advanced stage
Decreased best corrected visual acuity bellow 20/40, which cannot be further improved by use of soft contact lenses
Rigid contact lenses are either not tolerated or do not improve visual acuity
No previous eye surgery (except for laser refractive surgery)
All patients must provide written informed consent to become a study subject
Subjects able to return for scheduled follow-up examinations according to this protocol

Exclusion Criteria:

Corneal thickness < 400 µm at thinnest position
Keratometric - readings above 60 diopters
Other active ocular disease than keratectasia
Herpes keratitis
Previous ocular surgery (other than laser refractive surgery)
Patients who were immunocompromised, pregnant or who had atopic syndrome, connective tissue or autoimmune disease
Patients with known sensitivity to study medication
Subjects with intraocular pressure > 23 mmHg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspects
Subjects who intent to participate in other ophthalmic clinical trails during this clinical investigation

Gender

Both

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: ALEKSANDAR STOJANOVIC, MD	+47 77 64 79 20	aleks@online.no
Contact: ESPEN F BAKKE, MD	+47 22118545	espen.bakke@medisin.uio.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00435799

Responsible Party

ALEKSANDAR STOJANOVIC, MD, University Hospital of North Norway

Study ID Numbers ^ICMJE

UNN-UUS-CCL07

Study Sponsor ^ICMJE

Ullevaal University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Aleksandar Stojanovic, MD

Eye dpt, University Hospital of North Norway

Information Provided By

Ullevaal University Hospital

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP