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