Femtosecond Laser-Assisted Cataract Surgery (FLACS) - David Richardson, MD

Notas del editor

1. Femtosecond Laser Assisted Cataract Surgery (FLACS) How do the Marketing Promises Compare to Reality? PRESENTER: DAVID D. RICHARDSON, MD
2. I am David Richardson ● Cataract surgery education is one of my main points of focus. So much so that I’ve authored a book for patients, So, You’ve Got a Cataract? ● In my private practice in San Marino I routinely spend 45-60 minutes face-to-face with those patients who are interested in cataract surgery. The exam takes all of five minutes. The rest of that time is spent educating and addressing patient’s questions. ● Finally, as an Adjunct Assistant Professor of Clinical Ophthalmology at the USC Roski Eye Institute my primary role is to teach residents the operating room skills they will require in order to become adept cataract surgeons.
3. Conflicts of Interest ● It should be noted that I have no financial conflicts of interest to disclose. I neither consult for a Femto company nor do I own one. As such, you might find that this talk differs a bit from the usual vendor-sponsored Femto laser dinner talks.
4. What is Laser Cataract Surgery?
5. Laser Cataract Surgery is actually a misnomer. It is more properly called “Femto Laser-Assisted Cataract Surgery (FLACS)” As the laser is only used at the very beginning of the surgery. <click>
6. What Does the Laser Do? ● Create corneal incisions
7. What Does the Laser Do? ● Create corneal incisions ● Create an opening in the Capsular Bag
8. What Does the Laser Do? ● Create corneal incisions ● Create an opening in the Capsular Bag ● Soften the Cataract
9. What Does the Laser Do? ● Nothing that couldn’t already be done without the laser
10. Wait, what?! But, what about it being “more precise”, “safer”, and “gentler” on the eye? Marketing terms with little evidence of fact
11. I would also like to thank my esteemed colleague Dr. Steven Safran who generously introduced me to many of the studies I will be presenting today (this one included) Let’s see how the marketing promises hold up to real clinical trial scrutiny The late Dr Peter Barry recently presented priliminary results from the European Society of Cataract and Refractive Surgeons Femto Laser Assisted Cataract Surgery Study <click>
12. This was not a small study. In fact, it was hugh… ● 16 centers... <click>
13. ● 10 Europeans countries <click>
14. ● almost three thousand patients So, did this study support the marketing hype of better surgical outcomes? Let’s take a look… <click>
15. In a word, “NO” ● Patients who underwent FLACS had worse post-operative visual acuity... <click>
16. ● More post-operative complications… <click>
17. …and were more likely to have post-op visual acuity worse than pre-op Let’s read that again, were more likely to have post-op visual acuity worse than pre-op The entire reason people undergo cataract surgery is to improve vision. As such, any technique or technology that actually increases the risk of worse vision after surgery can hardly be considered an improvement. How could this be?<click>
18. Let’s take a closer look at the study data. Perhaps we can learn something <click>
19. FLACS marketing often touts “more precise” surgery. One would think that better precision would result in better targeting of refractive outcomes, yes? However, No real difference in refractive outcome was noted in the ESCRS FLACS study
20. Of keen interest is that there was a higher rate of post-operative complications with FLACS <click>
21. Higher rate of post-operative complications with FLACS ● Corneal Edema ○ 5x greater incidence ● Posterior Capsular Opacification ○ 6x greater incidece ● Anterior chamber reaction ○ 3x greater incidence This is both statistically as well as clinically significant <click>
22. OK, but that’s just one study... ● Albeit a very large, independent, and well-designed one...
23. So here’s another large study (almost 2,000 patients enrolled) that also showed no benefit of FLACS over conventional phaco And… <click>
24. as with the ESCRS FLACS study... ● Greater rate of undesired outcomes, including ○ Perioperative complications Look at those p values These findings are not subtle <click>
25. But, as with the ESCRS FLACS study... ● Greater rate of complications, including ○ Elevated IOP ■ 4x greater incidence ○ Cystoid macular edema ■ 8x greater incidence
26. It should be noted that these studies were not the first study to note increased risk of macular edema with FLACS In 2014 an Australian study noted Increased risk of cystoid macular edema after FLACS <click>
27. Why might this be? What could be going on during the laser portion of FLACS that could result in Corneal edema Increased anterior chamber reaction IOP elevation Cystoid macular edema Posterior capsular opacification <click>
28. Corneal Edema ● Endothelium is very sensitive to pH ○ FLACS results in an acidic shift in aqueous humor
29. Anterior Chamber Reaction ● Prostaglandins in aqueous after Femto treatment ○ Prostaglandins are a part of the inflammatory cascade <click>
30. Anterior Chamber Reaction (but wait, there’s more…) <click>
31. Anterior Chamber Reaction (but wait, there’s more…) ● Increased Inflammatory Cytokines after Femto treatment
32. Increased Incidence of Posterior Capsular Opacification ● Femto use associated with higher concentrations of fibroblast growth factor (FGF-2)
33. Increased Incidence of Posterior Capsular Opacification ● Conclusion from paper referenced in prior slide
34. Increased Incidence of Posterior Capsular Opacification ● Conclusion from paper referenced in prior slide
35. So where does that leave us? <click>
36. Let’s look at the real (not just the marketed) benefits of FLACS ● It’s cool ○ Come on, it’s a LASER!
37. Benefits of FLACS ● It’s cool ○ Come on, it’s a LASER! ● It’s fun for the surgeon Most ophthalmologists are a bit geeky and like their toys
38. And, there are ● Bragging rights for the patient It makes for good cocktail party or golf course talk. It’s the “latest” but as we’ve seen, perhaps not the greatest. <click>
39. But,...as we’ve just discussed… ● There’s no strong evidence from independent, peer-reviewed studies supporting an objective benefit of FLACS over conventional phacoemulsification <click>
40. Worse,... ● FLACS appears to be associated with greater pro-inflammatory changes in the aqueous humor that can lead to increased risks of: ○ Corneal edema ○ Anterior chamber reaction (iritis) ○ Cystoid macular edema ○ Posterior capsular opacification <click>
41. Still,... ● FLACS is in its infancy ● With tweaks to pharmacologic perioperative treatments, hardware, or even software it may be possible to reduce or even eliminate the rise in inflammatory mediators and with that, the added risks associated with FLACS <click>
42. Summary ● FLACS is not all it’s touted to be
43. Summary ● FLACS is not all it’s touted to be ● At the moment, there is no strong evidence that FLACS is superior to conventional phacoemulsification, and may actually be a step back at least with regard to intraocular inflammation and its associated risks/complications.
44. Summary ● FLACS is not all it’s touted to be ● At the moment, there is no strong evidence that FLACS is superior to conventional phacoemulsification, and may actually be a step back at least with regard to intraocular inflammation and its associated risks/complications. ● But with advances in technology it may have the potential to make good on at least some of its promises …just not yet <click>
45. Thank you
46. My practice information