clinical results with uvx

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

≥1D ≥2D0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

UV-X™ 1000

UV-X™ 2000

Latest results presented by Prof. Theo SeilerSeptember 2013

Optimized beam profile

Peripheral intensity 30% higher than ENERGY DOSE (not intensity)

=Increased biomechanical strengthening of the cornea

=improved corneal flattening

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

Cross-linking device No. of eyes

IROC Innocross UV-X 2269

CBM X-Linker (Sooft) 677

OptoGlobal 24

Avedro ??

Peschke ??