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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. Efficacy of T-CAT LASIK was excellent. At 3 months postoperatively, 31.6% of eyes achieved a UCVA of 20/12.5 or better; 68.9% of the eyes had a UCVA of 20/16 or better; and 92.7% of eyes had a UCVA of 20/20 or better. Over time, there was a slight improvement in UCVA through the 12-month examination after T-CAT LASIK. At 12 months, 34.4% of eyes saw 20/12.5% or better; 64.8% of eyes saw 20/16 or bet ter; and 92.6% of eyes saw 20/20 or better. At 3 months, 91.9% of eyes had an MRSE within 0.5 diopters (D) of the intended treatment, and 98.8% had an MRSE within 1.00 D of the in- tended treatment. At 12 months, 94.8% of eyes achieved MRSE within 0.50 D of the intended treat- ment, and 99.6% of eyes achieved an MRSE within 1.00 D of the intended treatment. Based on the clinical study outcomes, the potential for gains in vision performance are significant. Eyes treated with T-CAT demonstrated a shift toward an improvement in UCVA compared to preoperative BSCVA, with 29.6% of eyes gaining 1 or more lines of UCVA at 3 months compared with pre- operative BSCVA. At 12 months, 30.9% of eyes gained 1 or more lines of UCVA compared to preop- erative BSCVA. 1 In total, 89.9% of eyes were seeing at least as well without correction postoperatively as they did with best spectacle correction preopera- tively. In comparing preoperative BSCVA to postoper- ative 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 important for eye surgeons who want to effectively position it in their practice to choose patients who would be expected to respond similarly to the sub- jects who were treated in the FDA study. The oph- thalmic 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 Pearls for selecting patients and setting expectations 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 procedures, primarily with close attention to diagnostic topogra- phy scans for treatment export. However, as the FDA trial outcomes show, the additional attention to de- tail 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) Karl Stonecipher, MD Clinical associate professor of ophthalmology, UNC, medical director, TLC Greensboro, medical director, Laser Defined Vision, Greensboro, North Carolina 3

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