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Clinical results with UV-X
K-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%

The difference between the proportions are statistically significant.

Clinical data form Cumming, Seiler, Raiskup
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
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
Clinical results with uvx

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Clinical results with uvx

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