Clinical results with UV-XK-max comparison at 6 and 12 months

Safety aspects

K-max value

Change of Kmax @ 6 months

UV-X1000 (n=273); UV-X2000 (n=38)

Clinical data form Cummings, Seiler, Raiskup

Evaluation criteria

• Kmax > +1 D; continuation of progression (Failure)

• -1D < Kmax <+1D; no change

• Kmax < -1 D; improvement No progression(Success)

Change of K-max @ 6 months

No-progression(success)

Failure

UV-X™ 2000 91% 9%

UV-X™ 1000 79% 21%

Clinical data form Cumming, Seiler, Raiskup

The difference between the proportions are statistically significant.

Change of Kmax @ 12 months

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

≥1D ≥2D

UV-X™ 1000

UV-X™ 2000

Latest results presented by Prof. Theo SeilerSeptember 2013

Optimized beam profile

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)

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

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.

Evidence based data in KC

(peer reviewed) Aug. 2013

Thank you for your attention