Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

Keratoconus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00435799
• Other study ID #: UNN-UUS-CCL07
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 13, 2007
• Last updated: June 9, 2008
• Start date: February 2007
• Est. completion date: January 2010

Study information

• Verified date: January 2007
• Source: Ullevaal University Hospital
• Contact: ALEKSANDAR STOJANOVIC, MD
• Phone: +47 77 64 79 20
• Email: aleks[@]online.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• corneal cross-linking (CCL)

Drug:
• Riboflavin/dextran eyedrops

Device:
• UV-X system

Locations

Country	Name	City	State
Norway	Eye dpt, Ullevål University Hospital	Oslo
Norway	Eye dpt, University Hospital North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).
Primary	3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).