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14 result(s) for "Sitto, Mina"
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Comparing The Existing Myopic Keratorefractive Lenticule Extraction (KLEx) Platforms: A Narrative Review
Kerato-refractive lenticule extraction (KLEx) is an evolving technique in corneal refractive surgery. The objective of this narrative review is to compare laser settings, visual outcomes, and higher order aberrations (HOAs) across the five currently available myopic KLEx platforms, specifically SmartSight, corrective lenticule extraction for advanced refractive correction (CLEAR), smooth incision lenticular keratomileusis (SILK ), small incision lenticule extraction (SMILE ), and SMILE Pro . A comprehensive literature search was conducted in April 2025 using the PubMed, Scopus, and Embase databases, focusing on publications related to SmartSight, CLEAR, SILK, and SMILE Pro. For SMILE, a representative set of sources was selected due to the volume of available data. In total, 26 articles were included for this review. At the 1-day follow-up, 79% of eyes using SmartSight achieved an uncorrected distance visual acuity of 20/20, compared to 63% using SILK. These findings suggest that low pulse energy and high pulse frequency contribute to improved early visual outcomes, though the lenticule cut pattern also plays an important role. At 6 months, CLEAR, SILK, SMILE, and SMILE Pro showed high predictability, with over 85% of eyes achieving a spherical equivalent within ± 0.50 D. All platforms demonstrated excellent cylindrical correction, as over 87% of eyes achieved outcomes within ± 0.50 D. HOAs increased across all platforms, with significant induction of vertical coma. Overall, the five platforms demonstrated safety, efficacy, and refractive stability. This narrative review provides an overview of the current KLEx platforms and their clinical performance to compare differences in laser parameters and the factors influencing visual recovery, astigmatism correction, and HOA induction.
Comparing the Existing Myopic Keratorefractive Lenticule Extraction (KLEx) Platforms: A Narrative Review Response to Letter
Sabrina M Miller,1,* Mina M Sitto,2,3,* Kayvon A Moin,2,4 Phillip C Hoopes,2 Majid Moshirfar2,5,6 1Department of Neurology and Ophthalmology, Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA; 2Hoopes Moshirfar Research Center, Hoopes Vision, Draper, UT, USA; 3Department of Ophthalmology, Wayne State University School of Medicine, Detroit, MI, USA; 4Department of Ophthalmology, Nassau University Medical Center, East Meadow, NY, USA; 5John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA; 6Utah Lions Eye Bank, Murray, UT, USA*These authors contributed equally to this workCorrespondence: Majid Moshirfar, Hoopes Moshirfar Research Center, 11820 S. State St. #200, Draper, UT, 84020, USA, Tel +1 801-568-0200, Fax +1 801-563-0200, Email cornea2020@me.com
One-Year Prospective Contralateral Eye Study: Visual Outcomes of Topography-guided LASIK Versus KLEx for Myopia and Myopic Astigmatism
Purpose: To compare 12-month visual outcomes, higher order aberrations (HOAs), epithelial remodeling patterns, and patient-reported outcomes (PROs) between topography-guided laser in situ keratomileusis (TG-LASIK) and keratorefractive lenticule extraction (KLEx). Methods: Forty patients (80 eyes) underwent TG-LASIK in one eye and KLEx in the fellow eye for myopia with and without astigmatism. Preoperative and up to 12-month evaluations included uncorrected distance visual acuity (UDVA), corrected distance visual acuity, contrast sensitivity, HOAs, corneal epithelial analysis, corneal hysteresis (CH), corneal resistance factor (CRF), and PROs. Results: At 1 year, all eyes achieved a UDVA of 20/20 or better. Spherical equivalent (SEQ) stability did not differ between groups. TG-LASIK showed better contrast sensitivity than KLEx at 1 month (P < .001), which became comparable by 3 months. KLEx had more undercorrected cylinder than TG-LASIK at 12 months (P = .033), with 97.5% of TG-LASIK and 85% of KLEx eyes achieving a residual cylinder of 0.50 diopters or less (P = .02). KLEx induced higher vertical coma (P < .001), whereas spherical aberration remained statistically unchanged in both groups. By 1 month, KLEx removed 2.5 ± 3.4 μm/diopter more stromal tissue (P < .001); however, epithelial remodeling within the 2- and 5-mm zones compensated for this loss by 1 year. The decline in CH and CRF postoperatively was similar between platforms (P > .05). At 12 months, there was no difference in subjective and objective dry eye symptoms between groups. Conclusions: KLEx resulted in greater vertical coma, stromal consumption per diopter, and undercorrected cylinder. Although early differences in PROs, eye preference, and contrast sensitivity transiently favored TG-LASIK, both procedures were comparable in terms of stability, predictability, CH, CRF, and patient satisfaction at 12 months.
A Novel Missense Mutation in a Compound Heterozygous Patient with Fish-Eye Disease: A Case Report
Introduction: Fish-eye disease (FED) is a rare autosomal recessive disorder caused by a partial deficiency of lecithin-cholesterol acyltransferase (LCAT) activity. It is characterized by progressive corneal opacification and dyslipidemia in the absence of systemic manifestations. We describe the clinical presentation, optical coherence tomography (OCT) imaging findings, and Scheimpflug-based corneal densitometry results in a patient with FED carrying both a pathogenic variant and a novel missense variant of the LCAT gene not reported in the current literature. Case Presentation: We present a rare case of a 25-year-old female with bilateral corneal opacities, reduced plasma high-density lipoprotein cholesterol (<5 mg/dL), and elevated low-density lipoprotein cholesterol levels (>133 mg/dL). Visual acuity remained 20/20 in both eyes. Slit-lamp examination revealed diffuse subepithelial and anterior stromal deposits. The central corneal thickness was thinner than normal on Scheimpflug tomography, measuring 419 µm OD and 409 µm OS. OCT findings confirmed stromal thinning (479 µm OD and 470 µm OS), with preserved central epithelial thickness, and demonstrated corneal opacities throughout the cornea. Mean densitometry across the 12-mm corneal diameter was more than double that reported in healthy corneas. The cholesteryl ester-to-total cholesterol ratio remained within the normal range. Genetic analysis identified a previously reported pathogenic variant in exon 4 of LCAT (c.440C>T, p.Thr147Ile) and a novel missense mutation in exon 5 (c.715G>A, p.Gly239Ser), classified as a variant of uncertain significance. Conclusion: FED is a rare genetic disorder that is associated with corneal clouding and dyslipidemia. Genetic analysis confirmed the diagnosis with a compound heterozygous genotype, while OCT and corneal densitometry were effective modalities for quantifying and characterizing lipid deposits in FED.
Visual outcomes for the initial 500 eyes treated with keratorefractive lenticule extraction (KLEx) for myopia and myopic astigmatism at a single-site
Background: Keratorefractive lenticule extraction (KLEx) has become a widely used corneal refractive surgery. Since its approval by the United States Food and Drug Administration (FDA), there are relatively few studies from large US cohorts that have evaluated visual outcomes beyond one year using KLEx for myopia and myopic astigmatism. Studies are often limited by their small sample size and short follow-up duration. Methods: This was a retrospective study of 577 eyes from 314 patients who underwent KLEx between March 2017 and May 2024 at a single refractive surgery center. Inclusion criteria were myopia between -9.25 and -1.00 D, cylinder up to -3.00 D, and preoperative corrected distance visual acuity (CDVA) of 20/20 or better. Uncorrected distance visual acuity (UDVA), CDVA, manifest refraction, and complications were evaluated at 3 and 12 months postoperatively. Clinical outcomes were also compared to FDA premarket trials and large international cohorts. Results: Of 577 treated eyes, data were available at 3 months for 511 eyes (88.6% follow-up) and 12 months for 440 eyes (76.3% follow-up). Mean spherical equivalent (SEQ) improved from -5.35 ± 1.62 D (-9.63 to -1.38 D) to -0.04 ± 0.44 D (-1.88 to 1.88 D) (P < 0.001). Mean cylinder improved from -0.66 ± 0.66 D (-3.00 to 0.00 D) at baseline to -0.40 ± 0.32 D (-1.75 to 0.00 D) at 12 months (P < 0.001). Additionally, postoperative UDVA was 20/20 or better in 81% of eyes and 20/25 or better in 94% of eyes. Postoperative SEQ was within ±0.50 D in 85% of eyes and within ±1.00 D in 97% of eyes at 12 months. The SEQ remained stable across all postoperative visits, with a mean change of -0.03 ± 0.38 D from 3 to 12 months. There was a gain of one line of CDVA in 16% of eyes at 12 months, with no eyes losing two or more CDVA lines. Target-induced and surgically induced astigmatism were strongly correlated at both 3 and 12 months, with a mean undercorrection of 20% by one year (R² = 0.69). Conclusions: KLEx demonstrates predictable and safe correction of myopia and myopic astigmatism over 12 months in a US cohort. Visual outcomes meet or exceed FDA benchmarks and are consistent with published literature, although a potential need for improved cylindrical correction remains.
Comparison of Zeiss MEL90 and Alcon WaveLight EX500 Excimer Lasers in FDA Premarket Approval Trials for the Treatment of Myopia, Hyperopia, and Mixed Astigmatism
Background/Objectives: Although both the MEL90 (Carl Zeiss Meditec AG, Jena, Germany) and WaveLight EX500 (Alcon Laboratories, Inc., Fort Worth, TX, USA) are two widely used excimer lasers, comparisons between the two remain limited. This study evaluates visual and refractive outcomes from the U.S. Food and Drug Administration (FDA) premarket approval trials of these platforms in the treatment of myopia with and without astigmatism, hyperopia with and without astigmatism, and mixed astigmatism. Methods: Clinical outcomes from FDA premarket approval trials were compared between the recently approved MEL90 and the WaveLight (now termed EX500) excimer lasers. Results: A total of 714 eyes (358 patients) from MEL90 and 1353 eyes (706 patients) from EX500 were analyzed up to 6 months postoperatively. In the hyperopia/hyperopic astigmatism cohort, the EX500 demonstrated greater efficacy relative to MEL90, with more eyes achieving a postoperative uncorrected distance visual acuity (UDVA) of 20/20 or better (48.6% vs. 68.7%, respectively; p < 0.001). In both the MEL90 and EX500, at least 85% of eyes with myopia/myopic astigmatism and 68% with mixed astigmatism achieved a postoperative UDVA of 20/20 or better. For all refractive cohorts, more than 95% of eyes achieved a UDVA of 20/40 or better at 6 months (all p > 0.05). The EX500 was more likely to demonstrate an improvement of more than two lines of UDVA compared to baseline CDVA (all p < 0.05). In contrast, the MEL90 showed greater predictability of spherical equivalent within ±0.50 D and ±1.00 D for the hyperopia/hyperopic astigmatism cohort (both p = 0.007), as well as within ±0.50 D for the myopia/myopic astigmatism cohort (p < 0.001). Postoperatively, both platforms were associated with decreased glare and halos, although findings were variable in the EX500 mixed astigmatism cohort. Conclusions: Both excimer lasers demonstrated safe and effective outcomes that exceed the threshold set by the FDA.
A comparative study and review of visual outcomes with enhanced versus standard monofocal intraocular lenses following cataract surgery
Background: Recent innovations in intraocular lens (IOL) design have introduced extended depth of focus lenses, which has shown promise in improving visual acuity at multiple distances while preserving the distance vision provided by a standard monofocal IOL. This study aimed to evaluate the visual outcomes of TECNIS Eyhance, a monofocal IOL with enhanced intermediate function, and a standard TECNIS monofocal 1-piece IOL, and to review published studies comparing the clinical performance between the TECNIS Eyhance and standard IOLs. Methods: A retrospective analysis was conducted on patients who underwent cataract extraction with bilateral implantation of either TECNIS Eyhance IOLs or TECNIS Monofocal 1-Piece IOLs. Primary outcomes included monocular and binocular uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), and corrected distance visual acuity (CDVA), and manifest refraction. Outcomes such as glare, halos, and dry eye were also assessed. A literature review was performed to identify studies evaluating the clinical outcomes of TECNIS Eyhance and standard TECNIS monofocal IOLs. Results: In total 108 patients (216 eyes) underwent bilateral implantation with either TECNIS Eyhance (104 eyes) or TECNIS Monofocal 1-Piece (112 eyes) IOLs. The mean (standard deviation [SD]) binocular UNVA was better in the Eyhance group at 1 month (0.18 [0.13] logMAR) compared to the standard monofocal group (0.24 [0.14] logMAR; P < 0.05). A greater proportion of Eyhance patients achieved binocular UNVA of 20/25 or better (46.9% vs 21.8%; P < 0.01), and 20/32 or better (65.3% vs 45.5%; P < 0.05). However, there was no significant difference for 20/20 visual acuity (20.4% vs 18.2%; P > 0.05). No significant differences were observed in postoperative UDVA or CDVA between groups (both P > 0.05). The mean (SD) monocular UNVA showed a slight, but non-significant, advantage in the Eyhance group (0.26 [0.15] logMAR vs 0.29 [0.15] logMAR; P > 0.05). Eyhance eyes demonstrated less residual refractive cylinder at 1 month (P < 0.01), which may be attributed to a higher rate of toric IOL use (P < 0.01). Patient-reported visual symptoms did not differ between groups. Thirteen studies were identified that compared the Eyhance and standard monofocal IOLs. Across the studies analyzed, the Eyhance group showed better monocular and binocular UNVA with mean (SD) differences of - 0.10 (0.20) logMAR and - 0.10 (0.21) logMAR, respectively (both P < 0.01), as well as improved binocular uncorrected intermediate visual acuity (UIVA) (mean difference [SD]: -0.10 [0.18] logMAR; P < 0.01). These studies also showed low rates of glare and halos for both IOLs. Conclusions: Patients receiving the TECNIS Eyhance IOL had better binocular UNVA compared to those with a standard monofocal IOL, consistent with published literature. The Eyhance IOL also showed better binocular UIVA and monocular UNVA across the studies reviewed. Both enhanced and standard monofocal IOLs demonstrate excellent distance vision and have similar levels of photic phenomena. Nevertheless, the Eyhance IOL shows promising potential for improving intermediate and near vision.
Visual outcomes for the initial 500 eyes treated with keratorefractive lenticule extraction (KLEx) for myopia and myopic astigmatism at a single-site
Background: Keratorefractive lenticule extraction (KLEx) has become a widely used corneal refractive surgery. Since its approval by the United States Food and Drug Administration (FDA), there are relatively few studies from large US cohorts that have evaluated visual outcomes beyond one year using KLEx for myopia and myopic astigmatism. Studies are often limited by their small sample size and short follow-up duration. Methods: This was a retrospective study of 577 eyes from 314 patients who underwent KLEx between March 2017 and May 2024 at a single refractive surgery center. Inclusion criteria were myopia between -9.25 and -1.00 D, cylinder up to -3.00 D, and preoperative corrected distance visual acuity (CDVA) of 20/20 or better. Uncorrected distance visual acuity (UDVA), CDVA, manifest refraction, and complications were evaluated at 3 and 12 months postoperatively. Clinical outcomes were also compared to FDA premarket trials and large international cohorts. Results: Of 577 treated eyes, data were available at 3 months for 511 eyes (88.6% follow-up) and 12 months for 440 eyes (76.3% follow-up). Mean spherical equivalent (SEQ) improved from -5.35 ± 1.62 D (-9.63 to -1.38 D) to -0.04 ± 0.44 D (-1.88 to 1.88 D) (P < 0.001). Mean cylinder improved from -0.66 ± 0.66 D (-3.00 to 0.00 D) at baseline to -0.40 ± 0.32 D (-1.75 to 0.00 D) at 12 months (P < 0.001). Additionally, postoperative UDVA was 20/20 or better in 81% of eyes and 20/25 or better in 94% of eyes. Postoperative SEQ was within ±0.50 D in 85% of eyes and within ±1.00 D in 97% of eyes at 12 months. The SEQ remained stable across all postoperative visits, with a mean change of -0.03 ± 0.38 D from 3 to 12 months. There was a gain of one line of CDVA in 16% of eyes at 12 months, with no eyes losing two or more CDVA lines. Target-induced and surgically induced astigmatism were strongly correlated at both 3 and 12 months, with a mean undercorrection of 20% by one year (R² = 0.69). Conclusions: KLEx demonstrates predictable and safe correction of myopia and myopic astigmatism over 12 months in a US cohort. Visual outcomes meet or exceed FDA benchmarks and are consistent with published literature, although a potential need for improved cylindrical correction remains.