Journal of refractive surgery最新文献

Purpose: To evaluate visual performance of a novel full range of vision spiral intraocular lens (IOL) designed with artificial intelligence using preclinical and clinical metrics.

Methods: Preclinical visual performance was assessed in healthy individuals using a pseudophakic vision simulation device, comparing monocular corrected distance visual acuity, contrast sensitivity, defocus curve, halo/glare size, and subjective preference between the spiral RayOne Galaxy IOL and diffractive RayOne Trifocal IOL (Rayner). Additionally, postoperative clinical outcomes were subsequently analyzed from 10 sites following bilateral RayOne Galaxy IOL implantation. At 3 months postoperatively, key endpoints included subjective refraction, monocular and binocular uncorrected and corrected distance visual acuity at multiple distances, defocus curves, and patient-reported dysphotopsia.

Results: Preclinical evaluation demonstrated comparable range of focus between the Galaxy and diffractive Trifocal IOLs. However, the Galaxy IOL exhibited significantly less halo/glare, with nearly all participants preferring it across all distances. In the clinical study, mean monocular corrected distance visual acuities were -0.03 ± 0.08 logarithm of the minimum angle of resolution (logMAR) for distance, 0.05 ± 0.11 logMAR for intermediate, and 0.08 ± 0.14 logMAR for near, with further improvement observed binocularly. Monocular/binocular defocus curves demonstrated a smooth plateau with binocular defocus maintaining visual acuity of 20/32 (0.2 logMAR) or better from +1.00 to -2.80 diopters (35 cm). Halo and glare symptoms were generally minor (> 95% of patients), with no severe cases.

Conclusions: The Galaxy IOL provides excellent monocular and binocular visual acuity across all tested distances, with a smooth and continuous defocus curve ensuring full-range vision. Preclinical testing demonstrated significantly fewer photic phenomena than the tested diffractive trifocal IOL, whereas clinical investigations found no indications of bothersome side effects, together demonstrating high visual comfort.

Purpose: To evaluate the prevalence of satisfaction, dissatisfaction, and intolerance after presbyopia-correcting intraocular lens (PrC-IOL) implantation, identify primary causes of dissatisfaction, and assess the rate of spontaneous resolution of photic phenomena in a clinical setting.

Methods: This was a retrospective cross-sectional study of consecutive patients who had PrC-IOL implantation, including bifocal (ReSTOR; Alcon Laboratories, Inc), trifocal (Pan-Optix; Alcon Laboratories, Inc), diffractive extended depth-of-focus (EDOF) (Symfony; Tecnis), and non-diffractive EDOF (Vivity; Alcon Laboratories, Inc), at the Cole Eye Institute, Cleveland Clinic between January 2017 and December 2022. Evaluated variables included refractive outcomes, patient-reported satisfaction/dissatisfaction or intolerance, primary drivers of dissatisfaction, management strategies, IOL exchange rates, and spontaneous resolution of photic phenomena over time.

Results: A total of 493 patients (970 eyes) were evaluated. Overall, 87.2% reported satisfaction with their IOL outcomes, with 38% experiencing photic phenomena in the early follow-up. Dissatisfaction occurred in 12.8% of patients, with 7.7% of the total cohort reporting IOL intolerance. Blurry corrected vision (73%) and photic phenomena (50.8%) were the most common causes of dissatisfaction. Compared to satisfied patients, dissatisfied and intolerant patients had worse refractive outcomes and higher rates of photic phenomena. Among patients reporting photic phenomena at their initial stability visit and completing 1 year of follow-up, 43% experienced spontaneous resolution, most between 6 and 12 months. IOL exchange was performed in 2.4% of patients.

Conclusions: Most patients were satisfied with PrC-IOLs; however, in this analysis 12.8% reported dissatisfaction and 7.7% were intolerant to the lenses. Blurry corrected vision and photic phenomena were the leading causes of dissatisfaction. Spontaneous resolution of photic phenomena occurred in approximately one-third of cases but is less frequent among dissatisfied patients. IOL exchange may be necessary to alleviate symptoms.

Purpose: To critically reassess the scientific foundation of the 400-μm minimum corneal thickness threshold for endothelial safety in standard corneal cross-linking (CXL) with 3 mW/cm² ultraviolet A (UVA) irradiation.

Methods: A comprehensive analysis of the foundational studies that established this limit was conducted, with a focus on their methodological assumptions, modeling strategies, and translational weaknesses. Particular attention was given to the use of optical attenuation equations, riboflavin pharmacokinetics, and evolving imaging practices.

Results: The 400-μm threshold is derived from two seminal studies (one in vitro, one in vivo) that applied fixed assumptions about riboflavin concentration and stromal uniformity. Notably, the models used the Exponential Attenuation law and not the Lambert-Beer law, as opposed to what is frequently cited, to estimate UVA penetration. These estimations relied on simplified optical parameters, such as a uniform attenuation coefficient (μ = 53 cm^-1), without accounting for depth-dependent chromophore gradients, scattering, or biological variability. Moreover, the original threshold did not anticipate subsequent changes in riboflavin formulation and concentration, the use of alternative vehicles such as hydroxypropyl methylcellulose, or the emergence of accelerated and customized CXL protocols-factors that materially alter stromal pharmacokinetics and photochemical response.

Conclusions: The 400-μm guideline, although historically influential, is conceptually fragile. To establish a scientifically robust safety threshold in CXL, future models must incorporate validated attenuation coefficients, experimentally defined riboflavin diffusion dynamics, and patient-specific stromal properties. A more precise, data-driven framework is needed to support individualized decision-making, especially for CXL in thin corneas.

Purpose: To analyze the impact of keratometry, axial length (AL), anterior chamber depth (ACD), lens thickness (LT), central corneal thickness (CCT), and white-to-white distance (WTW) on the predictive accuracy of formulas included in the European Society of Cataract and Refractive Surgery (ESCRS) IOL power calculator.

Methods: This retrospective case series included 748 eyes from 748 patients. Postoperative refraction data were used to calculate refractive prediction errors (PEs) for the Barrett, Cooke K6, EVO, Hill-RBF, Hoffer QST, Kane, and Pearl-DGS formulas. Low, medium, and high subgroups were created based on the value of selected anatomical parameters. Statistical analysis included standard deviation, root mean square absolute errors (RMSAE), and stepwise multiple regression.

Results: Significant differences in formula performance were observed across subgroups. The Hoffer QST had a higher standard deviation than the Cooke K6, Kane, and Pearl-DGS in the subgroup with steep keratometry and a higher standard deviation than the Pearl-DGS in the subgroup with thin LT. The Kane had a lower standard deviation than the Cooke K6 in the subgroup with shallow ACD and a lower RMSAE than the EVO in the subgroup with deep ACD. The Cooke K6 had a lower standard deviation than the Hoffer QST in the subgroup with deep ACD. Anatomical parameters that significantly contributed to the PEs were: keratometry for the Pearl-DGS; AL for all formulas except the Hill-RBF; ACD for the Hill-RBF and Hoffer QST; LT for the Hill-RBF, Hoffer QST, and Pearl-DGS; CCT for the Pearl-DGS; and WTW for the Barrett and Kane.

Conclusions: Anatomical parameters significantly influence the accuracy of modern IOL power calculation formulas. These findings suggest that tailoring formula selection based on specific anatomical characteristics can improve refractive outcomes in cataract surgery.

Purpose: To assess the safety and effectiveness of sequential customized transepithelial phototherapeutic keratectomy (SCTK) performed after meniscus-shaped stromal lenticule addition keratoplasty (MS-SLAK) in patients with advanced keratoconus, with a focus on higher order aberrations (HOAs), corrected distance visual acuity (CDVA), and corneal biomechanics.

Methods: This prospective interventional study included patients previously treated with MS-SLAK for advanced keratoconus, showing corneal HOAs 3 μm or greater at a 4-mm pupil diameter and at least 200 μm of stromal thickness anterior to the implanted lenticule. All patients underwent SCTK using excimer laser ablation based on the corneal aberrometer, treating HOAs. Two sequential customized SCTK ablations were performed with intraoperative topographic reassessment. Patients were evaluated at baseline and at 3, 6, and 12 months postoperatively. Parameters included CDVA, manifest refraction spherical equivalent, corneal and ocular wavefront, tomographic data, and dynamic corneal response measurements.

Results: Six eyes from six patients were analyzed. The procedure resulted in significant visual improvement, with median spectacle CDVA improving from 20/125 to 20/32 at 12 months (P = .0001), and median contact lens CDVA reaching 20/25. HOAs significantly decreased, particularly root mean square (RMS) coma (from 3.3 (1.6) to 1.0 (0.5) μm, P = .02) and ocular RMS HOA (from 4.1 (1.8) to 1.8 (0.4) μm, P = .03). Corneal biomechanics remained stable throughout follow-up, with no signs of ectasia.

Conclusions: SCTK following MS-SLAK seems an effective sequential treatment strategy in advanced keratoconus. Combining biomechanical reinforcement with optical surface regularization enhances visual function and reduces HOAs, and could offer a viable alternative to corneal transplantation in selected cases.

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.

Purpose: To determine the magnitude of higher order aberrations (HOAs) induced from light delivery device treatments after implantation of a light adjustable lens (LAL; RxSight).

Methods: Patients who underwent cataract surgery or refractive lens exchange with LAL implantation in a private practice were included in this retrospective, consecutive chart review. The iTrace (Tracey Technologies) was used to measure corneal, internal, and total HOAs before each adjustment and lock-in visit at a 3-mm entrance pupil size. HOAs were also measured after the final lock-in visit. Overall and individual HOAs that were induced throughout the course of the LAL treatments were measured. Subgroup analysis was performed analyzing number of adjustments, distance versus near target, spherical aberration induced, target proximity, and history of refractive surgery.

Results: This study included 56 eyes from 32 patients. The mean induction of total HOAs (combined corneal and internal aberrations) was -0.005 μm (standard deviation = 0.071). No induced total HOAs were greater than 0.3 μm. The 32 eyes that had undergone prior refractive surgery were found to have a statistically significant increase in induced HOAs compared to the 24 eyes without prior refractive surgery (P = .02). No other statistically significant differences were detected during subgroup analysis.

Conclusions: This study suggests that LAL treatments do not induce a clinically significant amount of HOAs. However, eyes that have previously undergone refractive surgery may be more likely to have a greater magnitude of HOAs induced by light delivery device treatments.

Purpose: To develop a machine learning model for identifying eyes with previous myopic laser vision correction (LVC).

Methods: A total of 41,508 (35,269 eyes in 20,399 patients) and 5,517 (5,517 eyes in 3,210 patients) examinations performed at Seoul National University Bundang Hospital (SNUBH) and Seoul National University Hospital (SNUH), respectively, were included in this study. Using the SNUBH dataset, a machine learning model for identifying eyes with previous myopic LVC (ML-LVC) was developed. The SNUBH and SNUH datasets, respectively, were used as internal and external validation sets to investigate the performance of the ML-LVC model and to compare it with that of the Cooke-Riaz-Wendelstein (CRW1) index.

Results: The areas under the receiver operating curve of the ML-LVC model were 0.9970 (95% confidence interval [CI]: 0.9957 to 0.9981) and 0.9960 (95% CI: 0.9929 to 0.9982) in the internal and external validation sets, respectively. The accuracies of the ML-LVC model were 0.9908 (95% CI: 0.9886 to 0.9929) and 0.9927 (95% CI: 0.9906 to 0.9949) in the internal and external validation sets, respectively. The sensitivities of the ML-LVC model were 0.9528 (95% CI: 0.9342 to 0.9691) and 0.9222 (95% CI: 0.8802 to 0.9600) in the internal and external validation sets, respectively. The ML-LVC model exhibited significantly better prediction results, compared with the CRW1 index, in both the internal and external validation sets (McNemar's test, P = .004, P = .005, respectively).

Conclusions: The ML-LVC model showed better performance in identifying eyes with myopic LVC, compared with the CRW1 index. This model will benefit many ophthalmologists and is currently available on a web application.

Purpose: To investigate the ultrastructure and apoptosis of small incision lenticule extraction (SMILE) lenticules under different preservation conditions.

Methods: A total of 104 corneal stromal lenticules of 52 patients (13 men and 39 women, age 28.85 ± 6.45 years, mean spherical error -4.27 ± 1.34 diopters [D]) were collected from small incision lenticule extraction (SMILE) surgeries, and were immediately preserved using glycerol, silicone oil, Optisol (Bausch & Lomb), and cryopreservation for 1 day, 1 week, and 1 month. Fresh lenticules were taken as control groups. Hematoxylin-eosin (HE) staining and transmission electron microscopy (TEM) were applied for evaluation of ultrastructure and terminal-deoxynucleoitidyl transferase mediated nick end labeling (TUNEL) for cell apoptosis ratio. Changes of quantity of collagen in TEM were evaluated in each group among all time points.

Results: HE staining showed that collagen in the fresh lenticules had an orderly arrangement with few vacuoles. In each preservation group, vacuoles and changes in arrangement of collagen were observed. TEM showed that the mean density of collagen was lowest at 1 month in the glycerol, silicone oil, and cryopreservation groups and highest at 1 month in the Optisol group. Quantities of collagen of lenticules preserved for 1 day and 1 week in the Optisol group were not statistically significantly different from those in the fresh group. At the same storage time, the mean density of collagen was the highest in the cryopreservation group at 1 day and the Optisol group at 1 month, and there was no statistically significant difference among the other groups. There was no statistically significant difference in apoptotic cell ratio among groups.

Conclusions: SMILE lenticules preserved using glycerol, silicone oil, Optisol, and cryopreservation within 1 month maintain a similar cell viability level as fresh lenticules.