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

Sponsor:	Ullevaal University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00435799

Purpose

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.

Condition	Intervention	Phase
Keratoconus	Procedure: corneal cross-linking (CCL) Drug: Riboflavin/dextran eyedrops Device: UV-X system	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Riboflavin Dextrans

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

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).

Estimated Enrollment:	40
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Procedure: corneal cross-linking (CCL) Drug: Riboflavin/dextran eyedrops Device: UV-X system

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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435799

Contacts

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

Locations

Norway
Eye dpt, Ullevål University Hospital	Recruiting
Oslo, Norway, N-0407
Contact: Liv Drolsum, Prof MD PhD +47 22118545 liv.drolsum@uus.no
Contact: Espen F Bakke, MD +47 22118545 espen.bakke@medisin.uio.no
Principal Investigator: Liv Drolsum, Prof MD PhD
Eye dpt, University Hospital North Norway	Recruiting
Tromsø, Norway, No-9037
Contact: Aleksandar Stojanovic, MD +47 77 64 79 20 aleks@online.no
Principal Investigator: Aleksandar Stojanovic, MD

Sponsors and Collaborators

Ullevaal University Hospital

Investigators

Principal Investigator:

Aleksandar Stojanovic, MD

Eye dpt, University Hospital of North Norway

More Information

No publications provided

Responsible Party:	University Hospital of North Norway ( ALEKSANDAR STOJANOVIC, MD )
Study ID Numbers:	UNN-UUS-CCL07
Study First Received:	February 13, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00435799 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

keratoconus
corneal cross-linking
riboflavine
ultraviolet type A rays (UVA)

Additional relevant MeSH terms:

Corneal Diseases
Vitamin B Complex
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Keratoconus
Pharmacologic Actions

Photosensitizing Agents
Riboflavin
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamins
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on November 25, 2009