PURPOSE: To compare U.S. Food and Drug Administration (FDA)–reported visual and refractive outcomes following surgical correction of myopia and myopic astigmatism using the Visian Toric Implantable Collamer Lens (STAAR Surgical, Monrovia, CA) (Toric ICL), small incision lenticule extraction (SMILE), and topography-guided laser in situ keratomileusis (TG-LASIK). METHODS: FDA summary of safety and effectiveness data (SSED) were analyzed for each of the three platforms. Primary outcomes measured were efficacy, safety, stability, and accuracy of refractive correction. Stratified mean refractive spherical equivalent (MRSE) data were assessed. RESULTS: One hundred twenty-four Toric ICL patients (210 eyes), 357 SMILE patients (357 eyes), and 212 TG-LASIK patients (249 eyes) were included. SMILE eyes had a significant improvement in postoperative uncorrected distance visual acuity with respect to preoperative corrected distance visual acuity from 3 to 12 months ( P < .001), whereas TG-LASIK had no further improvement from 3 to 12 months ( P = .79). For preoperative MRSE greater than 10.00 diopters (D), there was a significant difference in the percentage of eyes achieving postoperative MSRE within ±0.50 D between Toric ICL (66%) and SMILE (100%) ( P < .001). SMILE was consistently more accurate than Toric ICL for cylinder within ±0.25 D ( P < .001), ±0.50 D ( P < .001), and ±1.00 D ( P = .0014). CONCLUSIONS: All three platforms analyzed in this study had excellent efficacy, safety, stability, and accuracy. Stratified analysis revealed that SMILE may be comparable to Toric ICL for patients with high myopia or myopic astigmatism, and SMILE may have a longer visual recovery compared to TG-LASIK than previously indicated. [ J Refract Surg . 2019;35(11):699–706.]

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Purpose: To report a case of pressure-induced interlamellar stromal keratitis (PISK) after small-incision lenticule extraction (SMILE) for the correction of myopic astigmatism in the United States. Methods: We report the case of a 27-year-old man who underwent uneventful SMILE surgery and presented with pressure-induced stromal keratitis. Anterior and posterior segment examination, uncorrected distance visual acuity, refraction, intraocular pressure, and pachymetry values are reported from this time period. Results: Three weeks postoperatively, examination revealed new-onset central corneal haze and edema in both eyes, more significant in the right eye. The patient was given a presumptive diagnosis of diffuse lamellar keratitis. Intensive corticosteroid treatment was administered, causing a significant decline in uncorrected distance visual acuity OD from 20/25 to 20/250 and OS from 20/20 to 20/60, with a significant myopic shift of −3.0 D and −1.0 D, respectively. In our case, pachymetry measurements revealed 78 μm OD and 43 μm OS of additional corneal thickness. Pressure readings were 25 mm Hg OD and 19 mm Hg OS, respectively. He was diagnosed with PISK, and after 4 days of steroid discontinuation and Brimonidine-Timolol administration, his symptoms had improved with resolution of corneal edema. Conclusions: Clinicians should be aware that PISK is a potential complication of SMILE. Postoperative intraocular pressure measurements are an important aspect of the management of postcorneal refractive surgery patients because the differentiation of PISK from diffuse lamellar keratitis, as well as the early detection and treatment of PISK, can avoid severe complications.

Hyperopia is a common form of refractive error in the United States. Many refractive errors can be treated with refractive surgery methods such as laser in-situ keratomileusis and photorefractive keratectomy; however, in patients with large degrees of hyperopia (≥+5.0 diopters [D]), these surgical methods are limited because of higher rates of refractive regression. Lenticule Intrastromal Keratoplasty (LIKE) is a surgical procedure that can be used to correct refractive errors in patients with high hyperopia. The authors describe the first intrastromal implantation of an allograft lenticule performed for the primary correction of hyperopia in the United States, and demonstrate that LIKE is potentially an effective procedure for the correction of high hyperopia. Mechanisms for achieving the intended refractive correction and the complications our patient experienced, including epithelial ingrowth and flap necrosis, are discussed.