Status:
UNKNOWN
Evaluating Collagen Cross-Linking (CCL) Treatment in Norway
Lead Sponsor:
Ullevaal University Hospital
Conditions:
Keratoconus
Eligibility:
All Genders
20-45 years
Phase:
PHASE2
PHASE3
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 ac...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00435799
Start Date
February 1 2007
End Date
January 1 2010
Last Update
June 10 2008
Active Locations (2)
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1
Eye dpt, Ullevål University Hospital
Oslo, Oslo County, Norway, N-0407
2
Eye dpt, University Hospital North Norway
Tromsø, Tromsø, Norway, No-9037