T-Cat Laser & Cross-linking for Keratoconus

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Keratoconus, Pellucid Marginal Degeneration

Intervention / Treatment
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* Procedure: Excimer laser ablation, and collagen cross-linking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional study<br>Patients with known keratoconus or pellucid marginal degeneration will be invited to join the study. The study is partly a continuation in the management of patients who have had previous keratophakia, who will have near-normal or supra-physiological levels of corneal thickness. It is also intended for patients with relatively mild keratoconus who have sufficient corneal thickness to allow a limited laser ablation whilst still leaving a residual stromal bed of at least 350μ. | Procedure: Excimer laser ablation, and collagen cross-linking<br>* 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.<br>* Other names: Pecshke UV-X illumination system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the pre- and post-operative unaided visual acuity, best corrected visual acuity, and refraction. |  | At six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal topographic profile. |  | At six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratoconus, pellucid marginal degeneration, corneal ectasia, collagen cross-linking, riboflavin, UV light, excimer laser, Topography-Computer Assisted Treatment (T-Cat), Wavelight Allegretto laser