Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00435799
First received: February 13, 2007
Last updated: June 9, 2008
Last verified: January 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Active Comparator: A Procedure: corneal cross-linking (CCL)
Other Names:
  • Riboflavine
  • UVX
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:

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

Exclusion Criteria:

  1. Corneal thickness < 400 µm at thinnest position
  2. Keratometric - readings above 60 diopters
  3. Other active ocular disease than keratectasia
  4. Herpes keratitis
  5. Previous ocular surgery (other than laser refractive surgery)
  6. Patients who were immunocompromised, pregnant or who had atopic syndrome, connective tissue or autoimmune disease
  7. Patients with known sensitivity to study medication
  8. Subjects with intraocular pressure > 23 mmHg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspects
  9. Subjects who intent to participate in other ophthalmic clinical trails during this clinical investigation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: ALEKSANDAR STOJANOVIC, MD, University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00435799     History of Changes
Other Study ID Numbers: UNN-UUS-CCL07
Study First Received: February 13, 2007
Last Updated: June 9, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
keratoconus
corneal cross-linking
riboflavine
ultraviolet type A rays (UVA)

Additional relevant MeSH terms:
Riboflavin
Keratoconus
Corneal Diseases
Eye Diseases
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014