SMILE for low Myopia

Transcription

1 SMILE for low Myopia Dr. Rainer Wiltfang North American Refractive Laser Symposium November 11-13, 2016

2 Smile for low Myopia Scientific literature

3 clinical outcomes Smile vs. Lasik

4 clinical outcomes Smile vs. Lasik

5 Smile for low Myopia Scientific literature Our clinical results

6 Smile Eyes Smile Eyes Erreichte Refraktionsänderung SEQ [dpt] Erreichte Refraktionsänderung SEQ [dpt] results Lasik versus Smile predictability (1m post OP) Lasik Streuung: angestrebt / erreicht SEQ 'VORHERSAGBARKEIT' 1068 Augen - 1 w postop 10 mittl. Abweichung (Betrag) -0,10 D (von -2,50 bis 1,25) Smile Streuung: angestrebt / erreicht SEQ 'VORHERSAGBARKEIT' 1831 Augen - 1 w postop 10 mittl. Abweichung (Betrag) -0,03 D (von -1,75 bis 1,13) 9 8 overcorrected 9 8 overcorrected undercorrected y = 1,00x 0 R 2 = 0, Angestrebte Refraktionsänderung SEQ [dpt] undercorrected y = 0,99x R 2 = 0, Angestrebte Refraktionsänderung SEQ [dpt]

7 Smile Eye Smile Eye results Lasik versus Smile safety (1m post OP) Lasik Smile Veränderung CC Visus 'SICHERHEIT' - in % Veränderung CC Visus 'SICHERHEIT' - in % 60% 50% 58% 53% month (eyes) 70% 60% 63% 57% month (eyes) 40% 30% 36% 32% 0,25 (877) 2 (845) 50% 40% 30% 29% 35% 0,25 (1827) 2 (2107) 20% 20% 10% 0% lost > 2 lost 2 1%0% lost 1 4%3% unchanged gained 1 gained 2 5% 6% 0%0% gained > 2 10% 0% lost > 2 lost 2 1%1% 3%3% lost 1 unchanged gained 1 gained 2 4%5% 0%0% gained > 2

8 Smile for low Myopia Scientific literature Our clinical results Treatment range

9 Smile recommended - myopia -3dpt up to -8 dpt - astigmatism up to 5 dpt - hyperopia not Allowed - myopia up to -10 dpt - astigmatism up to 6 dpt - hyperopie not

10 Smile for low Myopia Scientific literature Our clinical results Treatment range Methodological difficulties

11 Smile is all about precision of the incision Preventing tissue distortion is crucial Curved contact lens and corneal suction Prevent tissue distortion before the cut

12 Smile is all about precision of the incision Preventing tissue distortion is crucial Curved contact lens and corneal suction Prevent tissue distortion before the cut Low laser pulse energies Prevent tissue distortion during the cut

13 Why precision in small lenticule is more challenging? What happens during the creation of a lenticule? 1. The lower cut is created Lower cut is created. Optical breakdown generates plasma and consequently gas bubbles are formed. Intended cut Single gas bubble

14 Why precision in small lenticule is more challenging? What happens during the creation of a lenticule? 1. The lower cut is created 2. Single gas bubbles join 3. Joint gas bubbles deform surrounding lamallae Single gas bubbles join and form fewer but bigger gas bubbles. Those deform the surrounding tissue Intended cut Joint gas bubbles

15 Why precision in small lenticule is more challenging? What happens during the creation of a lenticule? 1. The lower cut is created 2. Single gas bubbles join 3. Joint gas bubbles deform surrounding lamallae 4. Upper cut is created Upper cut is created within the deformed tissue Intended cut Joint gas bubbles

16 Why precision in small lenticule is more challenging? What happens during the creation of a lenticule? 1. The lower cut is created 2. Single gas bubbles join 3. Joint gas bubbles deform surrounding lamallae 4. Upper cut is created 5. Tissue relaxes After relaxation, the real cut geometry deviates from the intended Real cut extracting such a lenticule would leave the eye with huge aberrations

17 Smile is all about precision of the incision Preventing tissue distortion is crucial Curved contact lens and corneal suction Prevent tissue distortion before the cut Low laser pulse energies Prevent tissue distortion during the cut Lenticule thickness >30µm Prevent tissue distortion during the cut

18 Smile is all about precision of the incision What happens during the creation of a lenticule? 1. The lower cut is created 2. Single gas bubbles join 3. Joint gas bubbles deform surrounding lamallae 4. Upper cut is created far away Upper cut is created within the deformed tissue > 30µm Intended cut Joint gas bubbles

19 Smile is all about precision of the incision What happens during the creation of a lenticule? 1. The lower cut is created 2. Single gas bubbles join 3. Joint gas bubbles deform surrounding lamallae 4. Upper cut is created far away 5. Tissue relaxes perfect shape of the lenticule After relaxation, the real cut geometry deviates from the intended Real cut Perfect lenticule shape less aberrations

20 Incrise the lenticule thickness from 29µm 20

21 Incrise the lenticule thickness to 34µm 21

22 Incrise the lenticule thickness and to 44µm 22

23 Smile Eyes Smile Eyes Erreichte Refraktionsänderung SEQ [dpt] Erreichte Refraktionsänderung SEQ [dpt] results Lasik (6.5mm) versus Smile (7mm) predictability (1m post OP) low myopic < 3dpt Lasik Smile Streuung: angestrebt / erreicht SEQ 'VORHERSAGBARKEIT' 490 Augen - 1 w postop Streuung: angestrebt / erreicht SEQ 'VORHERSAGBARKEIT' 409 Augen - 1 w postop 10 mittl. Abweichung (Betrag) -0,14 D (von -2,50 bis 1,00) 10 mittl. Abweichung (Betrag) 0,01 D (von -0,88 bis 0,88) 9 8 overcorrected 9 8 overcorrected undercorrected 2 1 undercorrected y = 0,93x Angestrebte Refraktionsänderung SEQ [dpt] R 2 = 0, y = 1,01x Angestrebte Refraktionsänderung SEQ [dpt] R 2 = 0,82

24 Smile Ey Smile Ey results Lasik (6.5mm) versus Smile (7.0mm) safety (1m post OP) low myopic < 3dpt Lasik Smile Veränderung CC Visus 'SICHERHEIT' - in % Veränderung CC Visus 'SICHERHEIT' - in % 70% 80% 60% 50% 62% 50% month (eyes) 0,25 (308) 70% 60% 70% 62% month (eyes) 0,25 (299) 40% 30% 20% 28% 36% 2 (253) 50% 40% 30% 20% 26% 36% 2 (258) 10% 0% lost > 2 lost 2 0% lost 1 3% 4% unchanged gained 1 gained 2 6% 9% 0%0% gained > 2 10% 0% lost > 2 lost 2 lost 1 2% 1% unchanged gained 1 gained 2 2%2% gained > 2

25 Lessons learned for low myopics Incrise the optical zone to 7.0mm 1 Incrise the minimal thickness if it s nesessary 2 Reduce the energy as low as possible 3 4 Take your time to remove the lenticule 25

26 Thank you for your kind attention! Correspondence: Dr. med. Rainer Wiltfang Smile Eyes Eye Clinic Munich Airport, Germany