Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435799
Status:
UNKNOWN
Last Update Posted:
2008-06-10
First Post:
2007-02-13
Brief Title:
Evaluating Collagen Cross-Linking CCL Treatment in Norway
Sponsor:
Ullevaal University Hospital
Organization:
Ullevaal University Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None