Early results at 1 and 3 months after Trans-PRK with AMARIS. a no-touch, one-step treatment

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1 Early results at 1 and 3 months after Trans-PRK with AMARIS a no-touch, one-step treatment

2 Trans-PRK advantages - No-Touch treatment in one step (much faster than in the past with 2 steps) - Significantly less dehydration, and therefore reduced risk of overcorrection - No alcohol required to loosen the epithelium, no damage to Bowmann s membrane due to mechanical abrasion - Diameter of the removed epithelium = Diameter of treatment zone - Faster wound healing - All combination of treatments are possible (aberration-free, corneal and ocular wavefront, PresbyMAX)

3 Fundamentals - About 70% of the population* have a central corneal pachymetry: of 55 microns and, at a distance of 8 mm, 65 microns - The ablation volume for removal of the epithelium is refractiveneutral, meaning it does not induce any hyperopic or myopic shift. - 2 ablation rates epithelial pulse rate is higher than the refractive pulse rate in the stroma - Ablation volume for the epithelial removal is significantly higher than the refractive volume - AMARIS with his ablation profile is the ideal laser *Epithelial thickness in the normal cornea: three-dimensional display with Artemis very high-frequency digital ultrasound. Reinstein DZ, Archer TJ, Gobbe M, Silverman RH, Coleman DJ. J Refract Surg Jun;24(6):571-81

4 Profile of Ablation Volume of ablation for a D: PRK 1860 nanolitres TransPRK 5135 nanolitres

5 Profile of Ablation Volume of ablation for a D: PRK 1860 nanolitres TransPRK 5135 nanolitres

6 Treatment Method Patient Selection: - Myopia up to -7 D and astigmatism up to 2.5 D of cylinder - Astigmatic correction over 1.0 D only in combination with cyclotorsion compensation (SCC) Medication pre-op: - Topical anesthetica with preservative-free eye drops - 3 minutes of rinsing with chilled BSS of 8 C

7 Treatment Method Technique: - Use of a speculum with extraction - Start of the treatment as soon as the cornea becomes dry Medication post-op: - 1 preservative-free ampoule of -> Voltaren / Dexamethason / Floxal - Usage of a bandage lens (Day&Night Ciba base curve of 8.9 mm) for 3 days - Daily: 2 x 1 ampoule Floxal and, every 2 hours, 1 ampoule chilled OculotectFluid - After removal of the bandage lens for another 10 days 4 x 2 drops of Efflumidex and 4 x ThiloTears gel - No MMC!

8 Demographics Number of eyes pre OP: 19 average 36 years (from 20 to 53) gender female 63.2% or 12 eyes male 36.8% or 7 eyes eye left 47.4% or 9 eyes right 52.6% or 10 eyes pre SR equiv: mean -3,37 D ± 1,75 D (from -6,22 to -1,00) pre SR sph: mean -2,99 D ± 1,82 D (from -6,10 to -0,50) pre SR cyl: mean -0,76 D ± 0,60 D (from -2,68 to 0,00) number of eyes 1 m: 19 (follow up rate 100%) post SR equiv: mean -0,09 D ± 0,41 D (from -1,00 to 0,50) post SR sph: mean 0,06 D ± 0,45 D (from -1,00 to 0,50) post SR cyl: mean -0,30 D ± 0,33 D (from -1,00 to 0,00) number of eyes 3 m: 19 (follow up rate 100%) post SR equiv: mean 0,05 D ± 0,34 D (from -1,13 to 0,38) post SR sph: mean 0,13 D ± 0,33 D (from -1,00 to 0,50) post SR cyl: mean -0,17 D ± 0,21 D (from -0,50 to 0,00)

9 0-19 > % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 39% 9% Age Distribution - Percentage 17% 13% 13% 9%

10 SEQ Histogram - Percentage 35% 30% 30% 26% 25% 22% 20% 15% 10% 9% 5% 4% 4% 4% 0% <= -8D -7D -6D -5D -4D -3D -2D -1D

11 Achieved [D] 7 Laser Settings SEQ vs. Achieved Change 1W 19 eyes 6 overcorrected 5 4 y = 1,02x R 2 = 0,87 Achieved [D] 7 Laser Settings SEQ vs. Achieved Change 3M 19 eyes 3 6 overcorrected undercorrected 4 y = 0,97x R 2 = 0, Laser setting SEQ [D] Achieved [D] Laser Settings SEQ vs. Achieved Change 1M 19 eyes overcorrected undercorrected Laser setting SEQ [D] 4 y = 0,93x R 2 = 0, undercorrected Laser setting SEQ [D]

12 Refractive outcome - Percentage within Attempted 100% 90% 80% 89% 100%100% 100% 94% 95% 89% 89% 81% month (eyes) 1 w (19) 1 m (19) 3 m (19) 70% 60% 50% 40% 42% 50% 58% 30% 20% 10% 0% +- 0, ,5 +- 1,0 +- 2,0 Refractive outcome - Percentage within Attempted 100% month (eyes) 1 w (19) 1 m (19) 3 m (19) 90% 80% 70% 60% 50% 40% 58% 89% 81% 30% 20% 10% 6% 5% 21% 13% 5% 11% 11% 0% -5 to -2-1,01 to -2-0,51 to ,5 +0,51 to +1 +1,01 to to +5

13 Change in CDVA - Percentage 'SAFETY' month (eyes) 0,25 (19) 1 (19) 3 (19) 100% 90% 80% 70% 60% 50% 40% 30% 20% 33% 1 patient who still has a CDVA of 20/20 50% 25% 17% 75% 95% 10% 5% 0% lost > 2 lost 2 lost 1 unchanged gained 1 gained 2 gained > 2

14 100% 90% UDVA - Percentage 'EFFICACY' 89% 80% month (eyes) 1 w (19) 1 m (19) 3 m (19) 70% 60% 50% 40% 30% 31% 50% 67% 20% 10% 11% 5% 19% 5% 17% 6% 0% 1,6 or better 1,3 1,0 0,8 0,6 0,5 0,4 or worse

15 2,00 Achieved Correction SEQ over Time 'STABILITY' 1,00 0,05-0,26-0,11 0,00 pre op 1 w 1 m 3 m -1,00-2,00-3,00-3,24-4,00-5,00-6,00 n=19 n=19 n=19 n=19

16 UDVA & CDVA over Time 1,4 6/5 20/15 1,2 6/6 20/20 1,0 1,01 0,94 1,00 6/8 20/25 0,8 0,75 0,96 6/10 20/30 0,6 0,80 6/15 20/50 0,4 0,56 6/30 20/100 0,2 0,0 0, pre op 1 w 1 m 3 m 6 m

17 Haze and Retreatments eyes with post-op haze No re-treatments n o o f eyes Haze 0 Haze 1 Haze 2 Haze 3 Haze 4 degree of haze Same patient

18 Take Home Message Our results with Trans-PRK comply with published outcomes in classical PRK / LASEK / EpiLASEK The main advantages are in a shorter treatment time and treatment in a single step Significant diminishing of post OP risks Smaller abrasion of epithelium and therefore faster re-epithelialisation with less discomfort and pain as well as less risk of infection due to faster epithelial healing In all patients, epithelium was closed at day 3 post-op I would like to see the development of devices which could measure the map of epithelial thickness, so that these parameters could be taken into account in the calculation of the ablation profile

19 PRK will survive! Thank You for your attention

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