Evaluating Collagen Cross-Linking (CCL) Treatment in Norway
NCT ID: NCT00435799
Last Updated: 2008-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2007-02-28
2010-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
corneal cross-linking (CCL)
Riboflavin/dextran eyedrops
UV-X system
Interventions
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corneal cross-linking (CCL)
Riboflavin/dextran eyedrops
UV-X system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
45 Years
ALL
No
Sponsors
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Ullevaal University Hospital
OTHER
Responsible Party
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University Hospital of North Norway
Principal Investigators
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Aleksandar Stojanovic, MD
Role: PRINCIPAL_INVESTIGATOR
Eye dpt, University Hospital of North Norway
Locations
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Eye dpt, Ullevål University Hospital
Oslo, Oslo County, Norway
Eye dpt, University Hospital North Norway
Tromsø, Tromsø, Norway
Countries
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Central Contacts
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Facility Contacts
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Liv Drolsum, Prof MD PhD
Role: primary
Espen F Bakke, MD
Role: backup
Aleksandar Stojanovic, MD
Role: primary
Other Identifiers
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UNN-UUS-CCL07
Identifier Type: -
Identifier Source: org_study_id