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| Name | Class |
|---|---|
| Accuvision Laser Eye Clinics | OTHER |
| Carleton Optical Equipment Ltd. | INDUSTRY |
| Bon Optics | OTHER |
| Sooft Italia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional study | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in the pre- and post-operative unaided visual acuity, best corrected visual acuity, and refraction. | At six months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal topographic profile. | At six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad K Rostron, MB BS | Moorfields Eye Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Department at St George's Hospital | London | London | SW17 0QT | United Kingdom |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D003911 | Dextrans |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| INDUSTRY |
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|
|
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |