prof. micheal mrochen presentation at the mediphacos user meeting 2013
DESCRIPTION
Clinical results with UV-X K-max comparison at 6 and 12 months Safety aspectsTRANSCRIPT
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