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Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
corneal cross-linking (CCL)
Riboflavin/dextran eyedrops
UV-X system
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, corneal cross-linking, riboflavine, ultraviolet type A rays (UVA)

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye dpt, Ullevål University HospitalRecruiting
  • Eye dpt, University Hospital North NorwayRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
February 13, 2007
Last Updated
June 9, 2008
Sponsor
Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00435799
Brief Title
Evaluating Collagen Cross-Linking (CCL) Treatment in Norway
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital

4. Oversight

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, corneal cross-linking, riboflavine, ultraviolet type A rays (UVA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
corneal cross-linking (CCL)
Other Intervention Name(s)
Riboflavine, UVX
Intervention Type
Drug
Intervention Name(s)
Riboflavin/dextran eyedrops
Intervention Type
Device
Intervention Name(s)
UV-X system
Primary Outcome Measure Information:
Title
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.
Title
2 Stability of the treatment will be evaluated based on keratometry and on manifest refraction spherical equivalent (MRSE).
Title
3 Safety will be evaluated based on the changes in distance best spectacle corrected visual acuity (BSCVA).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALEKSANDAR STOJANOVIC, MD
Phone
+47 77 64 79 20
Email
aleks@online.no
First Name & Middle Initial & Last Name or Official Title & Degree
ESPEN F BAKKE, MD
Phone
+47 22118545
Email
espen.bakke@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandar Stojanovic, MD
Organizational Affiliation
Eye dpt, University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye dpt, Ullevål University Hospital
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liv Drolsum, Prof MD PhD
Phone
+47 22118545
Email
liv.drolsum@uus.no
First Name & Middle Initial & Last Name & Degree
Espen F Bakke, MD
Phone
+47 22118545
Email
espen.bakke@medisin.uio.no
First Name & Middle Initial & Last Name & Degree
Liv Drolsum, Prof MD PhD
Facility Name
Eye dpt, University Hospital North Norway
City
Tromsø
ZIP/Postal Code
No-9037
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandar Stojanovic, MD
Phone
+47 77 64 79 20
Email
aleks@online.no
First Name & Middle Initial & Last Name & Degree
Aleksandar Stojanovic, MD

12. IPD Sharing Statement

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Evaluating Collagen Cross-Linking (CCL) Treatment in Norway

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