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Completed

NCT Number: NCT00777322

T-Cat Laser & Cross-linking for Keratoconus

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moorfields Eye Department at St George's Hospital

London, SW17 0QT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with known keratoconus or pellucid marginal degeneration.

Exclusion criteria

  • Age < 18 years > 50 years.
  • Minimal corneal pachymetry in eye to be treated of < 400μ.
  • Evidence of other corneal disease in the eye to be treated (e.g. Herpes simplex keratitis).
  • Women who are pregnant or nursing at the time of the initial treatment.
  • Presence of significant central corneal opacity.
  • Patients unwilling to not wear rigid contact lenses in the eye to be operated on for at least one month before baseline examination, and for the first six months post-operatively.

Treatment and study plan

Excimer laser ablation, and collagen cross-linking

Procedure

Surgery is performed with topical anaesthesia. The central corneal epithelium is removed. Excimer laser ablation is applied (typically 15-30 seconds). Residual bed thickness is checked with an ultrasonic pachymeter. Topical application of riboflavin 0.1% in dextran is commenced at 5 minute intervals. When an adequate saturation of the anterior chamber with riboflavin has been achieved, cross-linking treatment will proceed. Output from the UV light generating equipment is measured with a UV light meter and set at 3mW/cm². Thirty minutes of treatment is given, interrupted at five minute intervals by the application of more topical riboflavin drops. Finally the eye has a bandage soft contact lens placed, with preservative free topical antibiotic, steroid, and cycloplegic drop application.

Other names: Ricrolin (riboflavin 0.1% in dextran), Pecshke UV-X illumination system

Primary outcomes

  1. The difference in the pre- and post-operative unaided visual acuity, best corrected visual acuity, and refraction.

    Time frame: At six months

Secondary outcomes

  1. Corneal topographic profile.

    Time frame: At six months

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • Accuvision Laser Eye Clinics
  • Bon Optics
  • Carleton Optical Equipment Ltd.
  • Sooft Italia

Registry information

Official study title

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

Acronym: T-Cat

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2008
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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