2/22/2013. GOOD MORNING!! Thank you for all your referrals and for joining us today. The main focus of my presentation is to

Transcription

1 GOOD MORNING!! Thank you for all your referrals and for joining us today. Spring Symposium Vandi Rimer, OD March 2, 2013 The main focus of my presentation is to review current research articles with emphasis in refractive and cataract surgery. We have been long awaiting this new technology to come to the US. FDA has yet to approve this technology. Phase III clinical trials are currently underway There are Pro s and Con s One size treatment does not fit all, especially in astigmatic corrections, even if the power is the same between the two patients. This is where the topography guided ablation works well to address these subtle differences much more precisely. 1

2 It may be better for treating astigmatism As we all know, topography shows variations in astigmatism The astigmatism may be greater on the inferior portion of the cornea or the temporal vs nasal portion of the cornea. It is not always perfectly symmetrical Can work well to help correct patients who had previous LASIK complications: Decentered ablations Small optical zones Irregular corneas Better with ablation centration because it is centered on the apex of the cornea which is closer to the line of sight than the pupillary center. This is an important advantage in hyperopic treatments due to the possibility of large angle kappa in these patients. Smoothing and normalizing anterior surface irregularities such as corneal scars and irregularity due to keratoconus. Has been used in combination with CXL in KCN patients with promising results (2011 Journal of Cataract and Refractive Surgery). Direct relationship of data processing from the topo to the laser. The import feature allows the surgeon to eliminate the potential error of treating the wrong patient s data. It may not always produce the desired spherical refractive power outcome. Normalizes the cornea but as a result you may have either added or reduced spherical power. Patient may end up with a 20/50 outcome of +or D Requires more calculations and a little art from the surgeon The surgeon has to be experienced and requires a lot of thinking and calculations on their part. 2

3 Which topography system should be used? Placido disc Vs. Scheimpflug image Placedo disc technology was more accurate in the central 5mm zone but Scheimpflug is more accurate in the periphery. If problems with corneal clarity (Opacity/scars) the Scheimpflug image technology is more accurate. FDA trials are using Placido disc technology Which topography system should be used? Scheimpflug based technology gives better elevation data but it s curvature measurements are not as detailed as placido. Variability in topography from one image to the next; tear film, dry eye issues, contact lens wear can cause topo s to have a large variability between pictures. When is Topography guided ablation advised? Hyperopic patients Astigmatic patient s where the astigmatism is slightly asymmetrical Corneal irregularities Correcting complications Decentered ablations, small diameter treatments, irreg corneas Simple refractions, mild irregularities, If the cornea has a lot of irregularity, all bets are off in predicting the refractive outcome! Femtosecond only laser correction procedure No Eximer laser treatment needed Stromal lenticule is removed with the VisuMax laser using the Femtosecond Lamellar Extraction (ReLEX) and the Small Incision lamellar Extraction (SMILE ) method ReLEX allows for small flap sizes typically 0.5 to 1.0 mm larger than the optical zone. Not yet FDA approved in USA VIDEO ReLEx FLEx Surgery on Visumax Laser_large_WMV V9.wmv 3

4 ReLEX Smile.wmv Can treat up to D myopia and 5.00 D Cyl SMILE technique is becoming more favorable No risk of epithelial ingrowth Biomechanically leaves more support in corneal tissue, vs. creating the flap Less dry eye One surgeon in study stated he prefers ReLEx for astigmatism over 2.00 D and high myopes due to higher probability of enhancements Not as precise with low myopia but good with high myopes Undercorrection in high myopes is 0.1 +/- 0.4D in 800 pts Under corrects astigmatism by 25% (can fix w/ surgeon adj) Regression over 5 years is only 0.07D with ReLEx similar visual outcomes SMILE Outcomes with 3 mo follow up 332 eyes Pre-op Spherical Equiv D 83% had 20/25 UCVA post op which increased to 91% at 3 month post op 9 eyes (2.7%) lost 2 lines of BCVA 42 eyes (12.6%) lost 1 line of BCVA The surgeons say this is due to interface scatter Attempted correction vs achieved correction 77.1% within 0.50D 94.3% within 1.00D 95% of patients would recommend the refractive surgery to others French researches have found PRK can be safe and effective in patients with suspected KCN Patients must be carefully chosen 62 eyes classified as Keratoconus or suspects underwent PRK between 2004 and 2007 Average follow up time for the group 4.8 +/- 1.4 years Mean Spherical equiv RE /-0.92D Average Pachs 529 with thinnest spot 522 Post op average spherical equiv was /-1.25D Average post op K s /- 2.4D Only two patients needed to wear glasses due to myopic regression NO REPORTED CASES OF ECTASIA Researchers at the University of South Carolina say that Pre-op Punctal Occlusion in contact lens wearing dry eye sufferers leads to fewer dry eye complaints with LASEK 72 eyes of 36 pt s underwent LASEK, all pt s were contact lens wearers 2 different groups 1)Those who tested + as dry eye with Schirmers test and received punctal occlusion 2)Those who tested positive with Schrimers test and did NOT received punctal occlusion 25% with plugs had post op symptoms of dry eye 40% of those who did NOT received punctal plugs had symptoms of dry eye post op. 4

5 THE TRIPLE PLAY 45 Eyes with keratoconus Implantation of corneal ring segments first Patients followed until cornea and refraction stable approximately 6 months Epithelial removal, PRK with custom wavefront in central visual axis between the ring segments Immediately post PRK, initiate treatment with collagen cross linking on the same day. Significantly improved UCDVA and CDVA UCDVA from 20/100 to 20/40 (estimated from decimal to snellen acuity) CDVA from 20/40 to 20/25 (estimated from decimal to snellen acuity) Reduced central K values on topo s From ~ 51.0 DK to 46.5 DK Cornea and vision stabilized at the six month visit with very little change from 6-12mo post op Mild haze on 11% of patients No patients lost lines of CDVA Procedure is safe and effective!! Not yet FDA approved but something to consider off label l for this special patient t population 3.8mm Total diameter 1.6mm Aperture 5 μ Thick 5

6 8,400 micro-perforations (5-11µ) Pseudo-random pattern Maximize nutrient flow Minimize visual symptoms Sim-LASIK: Combines a LASIK correction to address refractive error with simultaneous implantation of an inlay Enrolled 360 eyes of 180 patients Mean age of 52.4 years ± 5.1 (SD) 6-month mean monocular acuities (N=64): Uncorrected near visual acuity improved by: 7 lines in hyperopic eyes, 6 lines in emmetropic eyes 2 lines in myopic eyes. Uncorrected distance visual acuity improved: 3 lines in hyperopic eyes, 1 lines in emmetropic eyes 10 lines in myopic eyes. *J Cataract Refract Surge 2012 Mar; 38(3): Grabner et al presented 4 year results at ESCRS 2011: Mean UCNVA (inlay eye): J2 Mean UCIVA (inlay eye): 20/25 Mean UCDVA (inlay eye): 20/20 Mean UCDVA (OU): 20/16 Yilmaz et al *, reported 4 years data in JCRS: Mean UNVA (inlay eye): J1 Mean UDVA (inlay eye): 20/25 The KAMRA inlay extends depth of focus by only allowing focused light rays to reach the retina Published clinical and commercial results are similar: Mean UNVA: J2-J3 J3 Mean UIVA: 20/20-20/25 Mean UDVA: 20/20 Can be used to treat a broad range of presbyopes Result remains stable over the long-term *J Cataract Refract Surge 2011; 37: Literature Review Article- Comparing multiple studies which looked at advantages, safety, efficacy and limitations of this technology 3 Technologies: LenSx Alcon(FDA approved)- Uses OCT for real-time images of anterior segment. Inside out procedure Lens chopped first, then capsulotomy and finally corneal incision created last. Surgeon then goes into the eye to irrigate and clean out the lens fragments. Catalys Precision Laser System -OptiMedica (FDA approved September 2012) liquid Optic Interface designed for docking which gives a clear optical pathway for OCT and laser treatment. Also has an image guidance system to help with surgeon precision. 6

7 LensAR (FDA approved)- high resolution 3D images Guides the laser based on biometry and ocular image readings of the patients anatomy. This unique technology provides very clean, low noise images that are high contrast and high resolution. It automates the lens fragment and corneal incisions. Laser has a no-touch patient interface. Can be performed within 3 minutes. All 3 Technologies are designed to help improve post operative results Lens implants are becoming more advanced Patients expectations for near-perfect vision is increasing Premium IOL s depend on precise centration for optimal performance Capsulorhexis FS may deliver a more circular, stronger, precisely planned capsulorhexis. Unpredictable diameter can lead to IOL decentrations with subsequent poor refractive outcomes, increased rates of PCO. Inappropriately sized capsulorhexis can lead decentration. 1mm shift can cause up to approx 1.25D change in refractive error. Lens fragmentation: Phaco Chop vs FS divide and conquer Ultrasound phacoemulsifcation carries risk of corneal injury due to ultrasound exposure, heat, mechanical manipulation. Femtosecond may show improved safety and decreased complications. Controversy still exists as to the amount of clinical relevance of the two different techniques. Less Higher Order Abberations One study with 50 eyes FLACS showed: Less induced Coma, less astigmatism, less lens position variability Comparing FLACS and Standard Cataract surgery One study in this journal review observed the differences between techniques FLACS 80% of eyes had small subconjuctival heme s in a ring pattern around the area where the suction ring was placed. Corneal Edema 30% FLACS pt s 70% standard Surgery pt s BCVA gain of 4.3 +/- 3.8 lines in laser group 3.5 +/- 2.1 lines in standard group although they were not clinically significant No significant difference in outcomes of BCVA, IOP, corneal thickness between the two groups, no major complications were reported in either group. Limitations of Femtosecond Laser Assisted Cataract Surgery (FLACS) Similar to limitations with femtosecond LASIK procedures Requires more patient cooperation Deep set orbits may be difficult for acquiring adequate suction Anterior Basement Membrane Dystrophies prone to epi slough Corneal scars bubbles not able to penetrate opacity Arcus peripheral opacity may be difficult to penetrate Pannus- may limit penetration Recurrent Epithelial Erosion more at risk for post op erosion Elevated IOP during surgery Patients more at risk Glaucoma, Optic Neuropathy Endothelial dystrophies Fuch s for example Additional Patient Considerations Poor dilation Posterior Synechia Diabetics with undiagnosed EBMD Floppy Iris syndrome Pseudoexfoliation Other Practice Considerations Additional cost vs. benefit Additional space for laser equipment Moving the patient from laser suite to operating room Surgeon efficiency how much time is added to the procedure 7

8 Besivance TID start immediately after surgery and continue for 1 week post op then stop. Durezol BID start immediately after surgery at 2 x a day for 1 week then 1 x a day for 1 week and stop. Preservative Free artificial tears every 30 minutes for first 2 days then every 1-2 hours for the first 1-2 weeks, then taper. Besivance TID start 2 days before surgery and continue until bandage lens removed. Nevanac TID or Acuvail bid start 2 days before surgery, take on the surgery day and for 2 additional days post op (5 days total) can continue to use for another day or two if pain. Durezol Start immediately after surgery TID x 2 weeks BID x 2 weeks QD x 2 weeks and stop. Doxycycline mg po bid #10 tablets start 2 days before surgery and continue 3 additional days (5 days total) Vitamin C mg po for 2 months Besivance TID for 1 week and stop Durezol TID x 14 days BID x 7 days QD x 7 days and stop Nevanac TID for 3 weeks and stop Only used in high risk for CME for ex. Diabetic patients, also consider if history of Iritis. Updates on Refractive surgery protocols The surgery kits are now FREE for Refractive Pt s Kit includes: Sunglasses, eye shields, medical tape, sample of Durezol, sample of Besivance, discount coupons for Durezol and Besivance. We will hand kit out at the testing visit or at check in on surgery day. Please feel free to call or me with any questions. vrimer@spivack.com