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C arefully selecting patients for treat- ment with topography-guided LASIK can help surgeons achieve the best possible outcomes, and carefully set- ting expectations can help patients achieve the best possible satisfaction levels. The key to both is for ophthalmic surgeons to familiarize themselves with the FDA trial outcomes upon which approval of topography-guided custom ablation treatments (T-CAT) were based. The FDA approved T-CAT LASIK for the treat- ment of eyes with myopia and myopic astigmatism. Specifics of the approval state that the WaveLight Allegretto Wave Eye-Q excimer laser system (Alcon, Fort Worth, Texas) used in conjunction with the WaveLight ALLEGRO Topolyzer (topographer) and T-CAT treatment planning software is indicated for performing T-CAT LASIK for the reduction or elimina- tion of up to –9 D of spherical equivalent myopia or myopia with astigmatism, with up to –8 D of spherical component and up to –3 D of astigmatic component at the spectacle plane. This indication is for patients who are 18 years of age or older and in patients with documentation of a stable manifest refraction defined as 0.50 D or less of preoperative spherical equivalent shift over 1 year prior to surgery. 1 Safe and effective The data derived from the FDA clinical trial demon- strated that T-CAT LASIK is a safe and effective treat- ment for myopia and myopic astigmatism. Notable visual acuity and quality of vision results were achieved for analyses of uncorrected visual acuity (UCVA) postop compared to best spectacle-corrected visual acuity (BSCVA) preoperatively, postoperative BSCVA compared to preoperative baseline, and improvements in visual symptoms. Based on the clinical study outcomes, the potential for gains in vision performance are signifi- cant. Eyes treated with T-CAT demonstrated a shift toward an improvement in UCVA compared to preop- erative BSCVA, with 29.6% of eyes gaining 1 or more lines of UCVA at 3 months compared with preopera- tive BSCVA. At 12 months, 30.9% of eyes gained 1 or more lines of UCVA compared to preoperative BSCVA. 1 In total, 89.9% of eyes were seeing at least as well without correction postoperatively as they did with best spectacle correction preoperatively. In com- paring preoperative BSCVA to postoperative BSCVA, 39.3% of eyes gained 1 or more lines at 3 months and 40.4% of eyes gained 1 or more lines at 12 months (Figure 1). Now that T-CAT is approved in the U.S., it is im- portant for eye surgeons who want to effectively po- sition it in their practice to choose patients who will respond similarly to the subjects who were treated in the FDA study. The ophthalmic community in the U.S. has been eagerly awaiting T-CAT with good reason. In addition to providing technology that has been shown to result in high rates of improved vision performance, it offers clinicians something new and exciting to discuss with and attract patients. In order to achieve outcomes similar to those produced by the FDA clinical trial, surgeons who employ this technology must commit to being involved in topography acquisition, interpretation and selection. In addition, it is important for the practice staff to understand and appreciate the difference between topography-guided ablations and other forms of refractive correction, such as wavefront-optimized and wavefront-guided LASIK. Topography use in driving ablation patterns offers a new opportunity to discuss personalized vision correction with patients and (the perhaps more easily understood) concepts of corneal topographic mapping in eyecare. T-CAT procedures do require additional plan- ning beyond that of wavefront-optimized proce- dures, primarily with close attention to diagnostic topography scans for treatment export. However, as Pearls for selecting patients and setting expectations the FDA trial outcomes show, the additional attention to detail and planning time are well spent. With T-CAT LASIK, there is an opportunity to raise the bar even further on visual performance, and that is ultimately what is most exciting about it. Reference 1. FDA device approvals website, Topography-guided Custom Ablation Treatment, or T-CAT Summary of Safety and Effectiveness Data (SSED), available at: www.fda.gov/MedicalDevices/ProductsandMedical- Procedures/DeviceApprovalsandClearances/Recently- ApprovedDevices/ucm372964.htm. by David W. Friess, OD, FAAO Figure 1. Postoperative BSCVA compared to preoperative BSCVA (change in lines) Dr. Friess is president of Optimus Clinical Partners LLC in Glen Mills, Pa. He was a clinical regulatory consultant for the FDA clinical trial of T-CAT LASIK performed with the Alcon WaveLight ALLEGRETTO WAVE Eye-Q laser. Dr. Friess can be contacted at dwfriess@gmail.com. 3

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