clinical results with uvx
DESCRIPTION
cornea, cross linking, clinical results, new technology, UV-X 1000, UV-X 2000, Theo Seiler, Michael Mrochen, Arthur Cummings, Frederick RaiskupTRANSCRIPT
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 ??