Clinical results with UV-X K-max comparison at 6 and 12 months Safety aspects

1. Clinical results with UV-X
K-max comparison at 6 and 12 months
Safety aspects

2. K-max value

3. Change of Kmax @ 6 months
UV-X1000 (n=273); UV-X2000 (n=38)
Clinical data form Cummings, Seiler, Raiskup

4. Evaluation criteria
• Kmax > +1 D; continuation of progression (Failure)
• -1D < Kmax <+1D; no change
• Kmax < -1 D; improvement
No progression
(Success)

5. Change of K-max @ 6 months
No-progression
(success)
Failure
UV-X™ 2000
91%
9%
UV-X™ 1000
79%
21%
The difference between the proportions are statistically significant.
Clinical data form Cumming, Seiler, Raiskup

6. Change of Kmax @ 12 months
100%
90%
80%
70%
60%
UV-X™ 1000
50%
UV-X™ 2000
40%
30%
20%
10%
0%
≥1D
≥2D
Latest results presented by Prof. Theo Seiler
September 2013

7. Optimized beam profile

8. Safety aspects
• No difference in terms of safety between the
two devices.
– Loss of CDVA of more then 2 lines < 1%
– Loss of endothelium cells (not significant)

9. Adverse events for both devices
•
•
•
•
•
•
•
•
Transient pain
Corneal haze
Corneal scars
Delayed epithelium closure
Sterile infiltrates
Corneal edema
Corneal erosion (recidive)
Corneal infections after CXL

10. Evidence based benefit / risk ratio
•
Benefits
–
–
–
–
–
•
Stabilization of the cornea
Stops the progression of KC
Improvement of subjective visual performance
Improved contact lens tolerance
Avoid keratoplasty surgery
Risk
–
–
–
–
Low risk of visual loss
Low risk for adverse events
Transient visual disturbances
Tolerable pain
Corneal cross linking can be considered to be effective and safe with a high
benefit and low risk ratio.

11. Evidence based data in KC
(peer reviewed) Aug. 2013

13. Thank you for your attention