CENTRO OFTALMOLOGICO GUSTAVO TAMAYO BOGOTA COLOMBIA LASIK XTRA GUSTAVO TAMAYO MD CLAUDIA CASTELL MD PILAR VARGAS MD

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1 CENTRO OFTALMOLOGICO GUSTAVO TAMAYO BOGOTA COLOMBIA LASIK XTRA GUSTAVO TAMAYO MD CLAUDIA CASTELL MD PILAR VARGAS MD From: BOGOTA LASER REFRACTIVE INSTITUTE Bogota, Colombia

2 DISCLOSURES FOR GUSTAVO TAMAYO MD 1. Member of the Advisory Board for AMO Inc. 2. Member of the Advisory Board PRESBIA Corp. 3. Member of the Advisory Board EYEGENICS Corp. 4. Latin America Medical Coordinator for AVEDRO Inc. 5. Member of speakers group of KERAMED Corp.

3 LASIK XTRA 1. Is a new concept: KXL at the time of a LASIK surgery. 2. Is new and therefore it should be seen as a procedure in development, with indications in progress and still not accepted for the entire Ophthamology community. 3. With the pass of time as with any new procedure, more and more indications will be found and eventually came to the point of making it in any Lasik surgery.

4 LASIK XTRA 4. It is a surgery that involves two reasons behind it: a) The proven fact creation of a flap will produce weakening of the cornea regardless of the method used. b) The proven fact Cross Linking works increasing the strength of the cornea. 5. With those two conditions together, sounds logical to increase the strength of the cornea when we perform a debilitating procedure such as Lasik.

5 DOES CROSS LINKING WORK? Of course!! Works in industry to strengthen polymers. It stabilizes tissues: -Chemical Crosslinking (Glutaraldehide) in preparation of heart valves and prothesis -Crosslinking with UV light in Dentistry for strengthening filling cavity paste THEO SEILER APPLIED THIS TECHNOLOGY TO EYE SURGERY (CORNEAL STRENGTH).

6 CLINICAL STUDIES CROSS LINKING Pilot study 1998 Prospective Documented progression of Keratoconus years 23 eyes F/U 3-47 months No progression in all cases after the treatment Wollensak, G., Spoerl E, Seiler T.: Riboflavin/Ultraviolet - A - Induced Collagen Crosslinking for the treatment of Keratoconus. Am J Ohthalmol 2003; 135 :

7 CLINICAL STUDIES CROSS LINKING Mean F/U 6 years 480 eyes. 272 patients 241 eyes were followed at least 12 months. Progressive Keratoconus: 1.0 D increase in K in one year UCVA and BCVA decrease Refraction change at least once in two years Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat L.: Collagen Crosslinking with Riboflavin and Ultraviolet A light in Keratoconus: Long term results. J Cataract Refract Surg, 2008; 34:

8 CLINICAL STUDIES CROSS LINKING 6 years : BCVA: 1 line increase in 53% p< 0.01 Astigmatism decreased 0.93 D in 50% p < 0.01 K apex : decreased 2.68 D in 62% p < 0.01 K highest : decreased 1.46 D in 56% p< 0.01 Stability: progression in only two patients Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat L.: Collagen Crosslinking with Riboflavin and Ultraviolet A light in Keratoconus: Long term results. J Cataract Refract Surg, 2008; 34:

9 Wollensack G et al Corneal Biomechanics SPEED Corneal Young s Modulus/MPa Increasing Stiffness 0 Control UV Cross-Linked 3mW 30Min UV Cross-Linked 30mW 3Min

10 FUERZA TENSIL CORNEANA Estroma anterior central 150 um 35 g/mm Membrana de Bowman 4% 1/3 anterior 61% sin MB 2/3 posteriores 30% sin MD Membrana descement 5% Epitelio 50 um 2g/mm Esclera g/mm E. medio y posterior central 20 g/mm E. anterior periferico 200um 40 g/mm E. Medio y posterior periferico 30 g/mm

11 Weak Cornea 6 mm Strong Cornea 160mm Weak Cornea 340mm Strong Cornea 8mm

12 LASIK INDUCED CORNEAL WEAKENING 40% % Corneal Weakening Due to Flap Creation Corneal Weakening 30% 20% 10% 0% 80µm 140µm 160µm 180µm Flap Depth Courtesy of Prof. John Marshall

13 LASIK XTRA 1. Jaycock PD, Lobo L, Ibrahim J, Tyrer J, Marshall J. Interferometric technique to measure biomechanical changes in the cornea induced by refractive surgery. Journal of cataract and refractive surgery. 2005;31(1): Tamayo, Castell, Vargas: ORA decrease after Femtosecond flap creation vs Microkeratome flap creation. White paper released and presented Subspecialty Day Refractive Surgery, AAO 2007

14 LASIK XTRA 1. Very short procedure: one and a half minute soaking time (Vibex Xtra) and one minute fifteen seconds UV. 2. Does not change the normal LASIK procedure itself. 3. Same ablation, same handling of the flap. 4. In my own cases we did not detect any change in the refractive result. 5. No complications added at all to the normal regular procedure of LASIK.

15 INCORPORATING LASIK XTRA INTO STANDARD LASIK SURGERY 1. Following excimer laser ablation in the flap bed Avedro s VīBex Riboflavin is applied to the flap bed: Isotonic 0.1% riboflavin 20% Dextran T500 ph The flap is repositioned and the cornea is then exposed to 30mW/cm 2 UVA for 2 minutes

16 LASIK XTRA PROTOCOL COMPARISONS Safety Energy Absorbed by Riboflavin vs. Corneal Depth (Flap Depth 120 µm) CXL- 30 minute 3 mw/cm² Kanellopoulos- 10 minute 7 mw/cm² Lasik Xtra 1.25 minute 30 mw/cm² MA-00057, Rev. A

17 LASIK XTRA ADVANTAGES 1. Can be carried out with Intralase or with Microkeratome flap. 2. Does not change the regular procedure. 3. Easy and simple for Doctor and Patient. 4. Does not change the final result of the ablation. 5. Can also be used regardless of the thickness of the flap, depth of ablation or type of Excimer Laser.

18 LASIK XTRA DISADVANTAGES 1. Slows down the procedure for a couple of minutes. 2. Increases the cost.

19 LASIK XTRA INDICATIONS STRONG CONSIDERATIONS 1. ABSOLUTELY CONTRAINDICATED IN THE PRESENCE OF ECTASIA. 2. ABSOLUTELY NOT INDICATED WHEN DEVELOPMENT OF ECASIA IS WARRANTED. 3. In such a case I prefer Surface Ablation plus Accelerated Cross Linking.

20 LASIK XTRA INDICATIONS 1. Young patients for Lasik (under 24 years of age). 2. Patients with severe ocular allergies, due to the risk of heavy rubbing. 3. Completely normal corneas, with no one sign of Keratoconus, but family history. 4. Thin corneas with complete normal preoperative evaluation (Risk of ectasia has been ruled out). 5. High myopes (large resections)

21 LASIK XTRA INDICATIONS 6. Retreatments, particularly if the thickness of the flap is not known. 7. Unexpected thick flap. 8. Irregular flaps with different thickness. 9. FINALLY IN ALL LASIK CASES: IF IT DOES NOT CHANGE THE RESULT WHY NOT???

22 LASIK XTRA: Predictable Visual Outcomes Retrospective Comparison of 66 Lasik eyes to 42 LASIK eyes treated for myopia Mean age: in the Lasik Xtra cohort and in the LASIK cohort Mean preoperative MRSE was D (Lasik Xtra), and D (LASIK). No adjustment was made to the excimer laser treatment nomogram to account for acxl, which was performed immediately following stromal ablation

23 LASIK XTRA: Predictable Visual Outcomes Retrospective Comparison of 66 Lasik eyes to 42 LASIK eyes treated for myopia Mean UCVA at 1 Day Post-Op 20/21 Lasik Xtra vs 20/20 LASIK Mean UCVA at 1 Week Post-Op 20/20 Lasik Xtra vs 20/20 LASIK Mean UCVA at 1 Month Post-Op 20/18 Lasik Xtra vs 20/20 LASIK

24 LASIK XTRA: Predictable Visual Outcomes Retrospective Comparison of 66 Lasik eyes to 42 LASIK eyes treated for myopia Mean MRSE at 1 Week Post-Op Lasik Xtra vs LASIK Mean MRSE at 1 Month Post-Op Lasik Xtra vs LASIK

25 LASIK XTRA: Predictable Visual Outcomes UCVA 1 Day Post Operative Lasik Xtra 0% 2% 2% LASIK 0% 17% 79% 16% 5% 63% 16% 20/15 20/20 20/25 20/30 20/40

26 LASIK XTRA: Predictable Visual Outcomes UCVA 1 Month Post Operative Lasik Xtra LASIK 0% 0% 62% 3% 3% 32% 4% 4% 81% 11% 20/15 20/20 20/25 20/30 20/40

27 LASIK XTRA EXAMPLE # 1 PREOPERATIVE POSTOPERATIVE

28 LASIK XTRA EXAMPLE # 2 PREOPERATIVE POSTOPERATIVE

29 LASIK XTRA EXAMPLE # 2 PREOPERATIVE POSTOPERATIVE

30 FOLLOW UP AT ONE YEAR From the 66 eyes we were able to examine 51 at one year. All 51 were 20/20 or better and 16 (31%) were 20/15. No complications were observed. 6 eyes had photosensitivity for around 12 weeks that were successfully treated with steroid drops Endothelial cell count was completely normal without change from pre op to post op.

31 CONCLUSION LASIK XTRA No need to change nomogram for LASIK procedures (Femto or microkeratome). No change in the final results when compared to same procedures without KXL. No haze or loss of lines of BCVA. Time for surgery is increased only few more minutes. Follow up at one year and one eye retreatment Lifting the flap was very easy (surgeon was not aware of the KXL at the time of enhacement).

32 THANK YOU!! NO RUBBING!!

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