Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract.

PURPOSE: To evaluate the effectiveness and safety of 2 enhanced monofocal intraocular lenses (IOLs). The TECNIS Eyhance IOL (Model ICB00) was compared with a standard monofocal IOL (TECNIS Monofocal, Model ZCB00). SETTING: European multicenter study. DESIGN: Prospective, bilateral, randomized, comparative/evaluator-masked, controlled study. METHODS: Adult subjects scheduled to undergo bilateral, primary phacoemulsification cataract extraction and posterior IOL implantation were randomized to receive the enhanced monofocal ICB00 IOL or the monofocal ZCB00 IOL in both eyes. Monocular endpoints at 6 months included distance-corrected intermediate visual acuity (DCIVA), photopic corrected distance visual acuity, and uncorrected intermediate visual acuity (UIVA). Binocular visual acuities, monocular corrected distance contrast sensitivity (first eyes), patient-reported outcomes, and safety were assessed at 6 months. RESULTS: Overall, 139 patients were bilaterally implanted with the enhanced monofocal IOL (n = 67) or standard monofocal IOL (n = 72) and available for the 6-month visit. The enhanced monofocal IOL significantly improved mean monocular and binocular DCIVA and UIVA by at least 1-line logarithm of the minimum angle of resolution vs the standard monofocal IOL (all P ≤ .0001). Distance vision for the enhanced monofocal IOL was 20/20 or better and comparable with that of the standard monofocal lens at 6 months. Contrast sensitivity, photic phenomena outcomes, and rates of adverse events were similar between the 2 groups. CONCLUSIONS: In patients undergoing cataract surgery, TECNIS Eyhance IOL Model ICB00 provided enhanced intermediate vision and similar distance performance and photic phenomena compared with a standard monofocal IOL, along with improved functional performance in daily life.

Enhancing the Intermediate Vision of Monofocal Intraocular Lenses Using a Higher Order Aspheric Optic.

PURPOSE: To describe and evaluate a new monofocal intraocular lens (IOL) designed to improve intermediate vision using a unique refractive technology. METHODS: The new monofocal lens is based on a higher order aspheric optic and is designed to improve intermediate vision. Simulated visual acuity from far to -2.00 diopters (D) was calculated using optical bench data. The effect of corneal higher order aberrations (HOAs) on simulated visual acuity, pupil size, and decentration was assessed using realistic computer eye models. The susceptibility to photic phenomena was evaluated by measuring preclinically the intensity of the light distribution in the retinal plane. The new lens design was compared to a standard aspheric monofocal IOL that shares the same platform, material, and primary spherical aberration as the new design. RESULTS: Simulated defocus curves showed increased simulated visual acuity in the intermediate range compared to a standard aspheric monofocal IOL with comparable distance vision, independently of the pupil size and corneal HOAs. At -1.50 D, the new IOL design provided a gain of approximately 0.1 logMAR, whereas at distance, the difference was less than 0.05 logMAR. The tolerance to decentration was also similar in both designs. Finally, experimental results indicate that the susceptibility to photic phenomena with the new lens design was similar to that of a standard aspheric monofocal IOL. CONCLUSIONS: Preclinical data showed that the new lens design improves intermediate vision while maintaining comparable distance image quality and keeping the same photic phenomena profile as a standard aspheric monofocal IOL. [J Refract Surg. 2020;36(8):520-527.].

New algorithm for toric intraocular lens power calculation considering the posterior corneal astigmatism.

PURPOSE: To assess the accuracy of toric intraocular lens (IOL) power calculations of a new algorithm that incorporates the effect of posterior corneal astigmatism (PCA). SETTING: Abbott Medical Optics, Inc., Groningen, the Netherlands. DESIGN: Retrospective case report. METHODS: In eyes implanted with toric IOLs, the exact vergence formula of the Tecnis toric calculator was used to predict refractive astigmatism from preoperative biometry, surgeon-estimated surgically induced astigmatism (SIA), and implanted IOL power, with and without including the new PCA algorithm. For each calculation method, the error in predicted refractive astigmatism was calculated as the vector difference between the prediction and the actual refraction. Calculations were also made using postoperative keratometry (K) values to eliminate the potential effect of incorrect SIA estimates. RESULTS: The study comprised 274 eyes. The PCA algorithm significantly reduced the centroid error in predicted refractive astigmatism (P < .001). With the PCA algorithm, the centroid error reduced from 0.50 @ 1 to 0.19 @ 3 when using preoperative K values and from 0.30 @ 0 to 0.02 @ 84 when using postoperative K values. Patients who had anterior corneal against-the-rule, with-the-rule, and oblique astigmatism had improvement with the PCA algorithm. In addition, the PCA algorithm reduced the median absolute error in all groups (P < .001). CONCLUSIONS: The use of the new PCA algorithm decreased the error in the prediction of residual refractive astigmatism in eyes implanted with toric IOLs. Therefore, the new PCA algorithm, in combination with an exact vergence IOL power calculation formula, led to an increased predictability of toric IOL power.

Hyperopic Q-optimized algorithms: a theoretical study on factors influencing optical quality.

In this work, we analyze the way in which pupil size, optical zone, and initial hyperopic level influence optical quality for hyperopic Q-optimized corneal refractive surgery. Different Q-optimized algorithms and the Munnerlyn formula were tested to analyze the optical quality of the final retinal image for initial hyperopic errors from 1D to 5D. Three optical zones (5.5, 6, and 6.5 mm) and two pupil diameters (5 and 7 mm) were considered. To evaluate optical quality, we computed the modulation transfer function (MTF) and the area under MTF (MTFa). Q-optimized values at around Q = -0.18 were found to provide the best optical quality for most of the conditions tested. This optimum final asphericity for hyperopic ablation was not depending on the degree of hyperopia corrected, the optical zone or the pupil size being this information important for clinical practice.

Q-optimized Algorithms: Theoretical Analysis of Factors Influencing Visual Quality After Myopic Corneal Refractive Surgery.

PURPOSE: To model the effect of pupil size, optical zone, and initial myopic level on the retinal image quality after Q-optimized myopic corneal refractive surgery. METHODS: Different Q-optimized and paraxial Munnerlyn algorithms were tested using a schematic myopic eye model to analyze the optical quality of the final retinal image for initial myopic errors from -1.00 to -7.00 diopters (D). Different optical zones (5.5, 6, and 6.5 mm in diameter) and two pupil diameters (5 and 7 mm, mesopic-scotopic conditions) were included in the comparison. Modulation transfer function (MTF) and area under the MTF from 0 to 60 cycles per degree (MTFa) were calculated by ray tracing to evaluate this retinal image quality. RESULTS: The Q-optimized algorithm with Q = -0.45 provided the highest MTF and MTFa results for myopic corrections less than -5.00 D. For refractive errors greater than -5.00 D, Q = -0.26 provided the highest MTF and MTFa results. CONCLUSIONS: Q-optimized algorithms improve the visual outcomes with respect to the paraxial Munnerlyn algorithm for myopic corneal surgery. The results show that the Q value that optimizes the results of the Q-optimized algorithm depends on the degree of myopia to correct and the size of the pupil. [J Refract Surg. 2016;32(9):612-617.].

Preclinical metrics to predict through-focus visual acuity for pseudophakic patients.

This study compares the clinical through-focus visual acuity (VA) in patients implanted with different intraocular lens (IOL) to optical bench testing of the same IOLs to evaluate the suitability of optical metrics of predicting clinical VA. Modulation transfer function and phase transfer function for different spatial frequencies and US Air Force pictures were measured using an optical bench for two monofocal IOLs, three multifocal IOLs and an extended range of vision IOL. Four preclinical metrics were calculated and compared to the clinical through-focus VA collected in three different clinical studies (243 patients in total). All metrics were well correlated (R(2)≥0.89) with clinical data and may be suitable for predicting through-focus VA in pseudophakic eyes.

Theoretical analysis for spherical aberration induction with low-order correction in refractive surgery: comment.

In this paper, we reply to post-surgical corneal asphericity conclusions made by Dai [Appl. Opt.51, 3966 (2012)]. We deduced, after a theoretical analysis, that the conclusions derived from this analysis are not theoretically or experimentally sound, because the author considers only the Munnerlyn formula for ablation algorithms and not the paraxial Munnerlyn formula, which is widespread in refractive surgery [J. Cataract Refract. Surg.14, 46 (1988)]. We refer to a previous paper published by Jiménez et al. [J. Opt. Soc. Am. A21, 98 (2004)] for a complete analysis on this matter that clarifies some points of confusion in Dai's paper.

Designing multifocal corneal models to correct presbyopia by laser ablation.

Two multifocal corneal models and an aspheric model designed to correct presbyopia by corneal photoablation were evaluated. The design of each model was optimized to achieve the best visual quality possible for both near and distance vision. In addition, we evaluated the effect of myosis and pupil decentration on visual quality. The corrected model with the central zone for near vision provides better results since it requires less ablated corneal surface area, permits higher addition values, presents stabler visual quality with pupil-size variations and lower high-order aberrations.

Theoretical analysis of the effect of pupil size, initial myopic level, and optical zone on quality of vision after corneal refractive surgery.

PURPOSE: To analyze the theoretical effect that pupil size, optical zone, and initial myopic level have on the final retinal image after corneal refractive surgery. METHODS: A schematic myopic eye model corrected by the Munnerlyn formula was used to analyze the optical quality of the final retinal image. Root-mean-square radius spot and modulation transfer function were cal- culated by ray tracing to evaluate retinal image quality. RESULTS: Pupil size had a negative effect on the retinal image only when it was greater than the diameter of the optical zone. In addition, the greater the initial myopic level, the more the pupil size affected image quality. Thus, a clear dependence exists between the initial myopic level and effect that the pupil size can have on the retinal image after laser refractive surgery. CONCLUSIONS: Pupil size may be a risk factor for night vision disturbances, but only when it is larger than the theoretical optical zones utilized in this study. Its effect depends not only on the optical zone size, but also on the initial "myopic level. Therefore, this relationship should be taken into account during patient selection for refractive surgery

Visual evaluation of different multifocal corneal models for the correction of presbyopia by laser ablation.

PURPOSE: To evaluate the visual quality of two theoretical multifocal corneal models designed to correct presbyopia by corneal photoablation. METHODS: Two theoretical multifocal corneal surfaces were analyzed by ray tracing: a central model (with a central zone for near vision and a peripheral zone for distance vision), and a peripheral model (with a central zone for distance vision and a peripheral zone for near vision). For both models, the effect of the size of the central zone and transition zone as well as the size of the pupil was evaluated. RESULTS: Our results show that a smaller transition zone favors total visual quality in both models. The optimal size of the central zone depends both on the size of the transition zone used as well as the model. However, both models responded similarly with respect to the variations in pupil size, providing the same visual quality although in an opposite way. CONCLUSIONS: This work shows that the optimal diameter of the central zone is smaller for the central model than for the peripheral model. Also, pupil size plays a fundamental role in achieving multifocality, showing that patient's pupil size should be thoroughly evaluated prior to multifocal refractive surgery.

Visual quality after monovision correction by laser in situ keratomileusis in presbyopic patients.

PURPOSE: To evaluate visual quality after laser in situ keratomileusis (LASIK) performed to achieve monovision in presbyopic patients. SETTING: Laboratory of Vision Sciences and Applications, Department of Optics, University of Granada, Granada, and Clínica Novovisión, Madrid, Spain. DESIGN: Cohort study. METHODS: Laser in situ keratomileusis was performed with the Allegretto Wave Eye-Q 400 Hz laser. The dominant eye was corrected for far vision and the nondominant eye for near vision by targeting -1.25 diopters of myopia. The F-CAT algorithm was programmed targeting a postsurgical corneal asphericity of -0.80 in the dominant eye and -1.00 in the nondominant eye. Visual acuity, contrast sensitivity function, ocular aberrations, stereoacuity, the scattering index, and the visual-discrimination capacity were analyzed preoperatively and 3 months postoperatively. RESULTS: The study enrolled 25 patients (50 eyes) with a mean age of 49.3 years ± 4.5 (SD). Postoperatively, more than 90% of patients had a binocular uncorrected distance and near visual acuity of 0.0 logMAR or better, although the contrast sensitivity function diminished, especially in the nondominant eye and with binocular vision. Stereoacuity was significantly worse in all patients (P<.001). The visual discrimination capacity declined in nondominant eyes and under binocular conditions (P<.005); no significant changes occurred in dominant eyes (P=.614). In all eyes, the mean objective scatter index value increased postoperatively, but not significantly (P>.05). CONCLUSIONS: Monovision correction by LASIK improved functional near vision in presbyopic patients. Although visual acuity was good for far vision, contrast sensitivity and stereoacuity diminished significantly.

Optical quality and visual discrimination capacity after myopic LASIK with a standard and aspheric ablation profile.

PURPOSE: To determine whether the eye's optical quality is correlated to the visual discrimination capacity of patients treated with LASIK using two different ablation algorithms. METHODS: Visual discrimination was evaluated by the disturbance index under low illumination (Halo v1.0 software, Laboratory of Vision Sciences and Applications) in two groups of patients who underwent LASIK with two different ablation algorithms using the Allegretto Wave Eye-Q 400 Hz laser (WaveLight AG). In the first group (standard group; 30 eyes), corneal ablations were performed with the standard algorithm (preoperative spherical equivalent refraction -3.20±1.70 diopters [D]). In the second group (Q-optimized group; 38 eyes; spherical equivalent refraction -3.40±1.90 D), the ablations were made with the Q-optimized (F-CAT) algorithm. Optical quality of the eye was calculated by the Strehl ratio measured with a double-pass device (OQAS, Visiometrics SL). RESULTS: After LASIK, both the Strehl ratio as well as visual discrimination capacity diminished in both groups, although the changes were significantly greater in the standard group than in the Q-optimized group. CONCLUSIONS: A high correlation was found between the Strehl ratio and the disturbance index in patients who underwent LASIK, regardless of the ablation algorithm applied. Optical and visual deterioration were greater after standard ablation.

Characterizing corneal shape after LASIK using a reference system intrinsic to the cornea.

The reliability of using a reference system intrinsic to the cornea has been evaluated in order to characterize corneas of subjects after refractive surgery. Data on 90 eyes operated on by LASIK to correct myopia and astigmatism were considered. The corneal parameters (curvature radii and corneal asphericity) found with respect to this reference system are compared with the parameters provided directly by the corneal topographer. The corneal parameters referenced to the intrinsic main axes of the cornea allow a better characterization of the corneal geometry, showing lower variability and diminishing the dissimilarities between the different eyes. The use of these parameters reduces the discrepancies between the real experimental and the theoretically predicted values (21% mean relative error using intrinsic data versus 81% using the topographer data). To understand and reduce these differences is essential in refractive surgery.