T-Cat Laser & Cross-linking for Keratoconus — T-Cat  

Keratoconus Clinical Trial

Official title: Pilot Study of Excimer Laser Topography-Computer Assisted Treatment (T-Cat) Combined With Corneal Collagen Cross-linking With Riboflavin and UV Light

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

• Keratoconus
• Pellucid Marginal Degeneration

• NCT number: NCT00777322
• Study type: Interventional
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Completion date: October 2010