Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

June 9, 2008 updated by: Ullevaal University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aleksandar Stojanovic, MD
  • Phone Number: +47 77 64 79 20
  • Email: aleks@online.no

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, N-0407
        • Recruiting
        • Eye dpt, Ullevål University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liv Drolsum, Prof MD PhD
      • Tromsø, Norway, No-9037
        • Recruiting
        • Eye dpt, University Hospital North Norway
        • Contact:
          • Aleksandar Stojanovic, MD
          • Phone Number: +47 77 64 79 20
          • Email: aleks@online.no
        • Principal Investigator:
          • Aleksandar Stojanovic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Procedure: corneal cross-linking (CCL)
Other Names:
  • Riboflavine
  • UVX
Drug: Riboflavin/dextran eyedrops
Device: UV-X system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Investigators

  • Principal Investigator: Aleksandar Stojanovic, MD, Eye dpt, University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

February 13, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 10, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNN-UUS-CCL07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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