Corneal ectasia Eye Diseases Corneal deformities
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Corneal ectasia (keratoconus, pellucid marginal degeneration or post-excimer laser corneal ectasia) in patients intolerant or with limited tolerance of contact lenses. The only other options would be INTACS or corneal grafting.
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years or greater than 40 years 2. Maximal K greater than 60D 3. Minimal Oculus Pentacam pachymetry less than 400 u, to avoid the risk of endothelial damage 4. Evidence of other corneal disease in the eye to be treated (e.g., herpes simplex keratitis) 5. Women who are pregnant or nursing at the time of the initial treatment 6. Presence of significant central corneal opacity 7. Patients unwilling to not wear their rigid contact lenses in the eye to be treated for at least one month before baseline examination, and for the first six months post-operatively (this will be necessary in order to obtain accurate refraction and keratometry readings)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the pre- and post-operative: 1. Unaided visual acuity 2. Best corrected visual acuity 3. Refraction | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal topographical profile, measured pre-operatively and at one and six months post-operatively. | — |
Countries
United Kingdom