Clinical Trial: T-Cat Laser & Cross-linking for Keratoconus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study of Excimer Laser Topography-Computer Assisted Treatment (T-Cat) Combined With Corneal Collagen Cross-linking With Riboflavin and UV Light
Brief Summary: The purpose of this study is to determine whether excimer laser corneal surface ablation (T−Cat) can be safely combined with simultaneous corneal collagen cross−linking treatment to produce an improved and stable corneal profile in the treatment of keratoconus.
Detailed Summary:
Theoretical framework:
Corneal ectasia is a relative weakness in the structure of the cornea, which produces a progressive change in its shape with resultant visual distortion.
Excimer laser surface ablation can be used to re−shape the corneal profile. When the corneal shape is very irregular, corneal topography data gives the best information as to how to re−shape the cornea into a normal profile, and this Topography−Computer Assisted Treatment (T−Cat) will be used to modulate the surface corneal shape.
It is known that collagen cross−linking in the cornea occurs naturally with age, and in diabetes, both of which seem to prevent progressive ectasia. Corneal collagen cross−linking with riboflavin has been shown to stabilize the cornea in keratoconus, and prevents progression of the disease. If cross−linking is performed at that moment that the cornea has been re−shaped by T−Cat treatment, it should help prevent the corneal thinning resultant from the laser treatment from destabilising the cornea and causing progressive ectasia.
Purpose:
To determine whether excimer laser corneal surface ablation (T−Cat) can be safely combined with simultaneous corneal collagen cross−linking treatment to produce an improved and stable corneal profile.
Design:
Prospective, interventional trial.
Sponsor: Moorfields Eye Hospital NHS Foundation Trust
Current Primary Outcome: The difference in the pre− and post−operative unaided visual acuity, best corrected visual acuity, and refraction. [ Time Frame: At six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Corneal topographic profile. [ Time Frame: At six months ]
Original Secondary Outcome: Same as current
Information By: Moorfields Eye Hospital NHS Foundation Trust
Dates:
Date Received: October 21, 2008
Date Started: October 2008
Date Completion:
Last Updated: July 20, 2011
Last Verified: April 2009
