Extended Depth Of Focus Lenses Research Articles

Enhancement of the Inner Foveal Response of Young Adults with Extended-Depth-of-Focus Contact Lens for Myopia Management.

Myopia management contact lenses have been shown to successfully decrease the rate of eye elongation in children by changing the peripheral refractive profile of the retina. Despite the efforts of the scientific community, the retinal response mechanism to defocus is still unknown. The purpose of this study was to evaluate the local electrophysiological response of the retina with a myopia control contact lens (CL) compared to a single-vision CL of the same material. The retinal electrical activity and peripheral refraction of 16 eyes (16 subjects, 27.5 ± 5.7 years, 13 females and 3 males) with myopia between -0.75 D and -6.00 D (astigmatism < 1.00 D) were assessed with two CLs (Filcon 5B): a single-vision (SV) CL and an extended-depth-of-focus (EDOF) CL used for myopia management. The peripheral refraction was assessed with an open-field WAM-5500 auto-refractometer/keratometer in four meridians separated by 45° at 2.50 m distance. The global-flash multifocal electroretinogram (gf-mfERG) was recorded with the Reti-port/scan21 (Roland Consult) using a stimulus of 61 hexagons. The implicit time (in milliseconds) and response density (RD, in nV/deg2) of the direct (DC) and induced (IC) components were used for comparison between lenses in physiological pupil conditions. Although the EDOF decreased both the HCVA and the LCVA (one and two lines, respectively; p < 0.003), it still allowed a good VA. The EDOF lens induced a myopic shift in most retinal areas, with a higher and statistically significant effect on the nasal retina. No differences in the implicit times of the DC and IC components were observed between SV and EDOF. Compared with the SV, the EDOF lens showed a higher RD in the IC component in the foveal region (p = 0.032). In the remaining retinal areas, the EDOF evoked lower, non-statistically significant RD in both the DC and IC components. The EDOF myopia control CL enhanced the response of the inner layers of the fovea. This might suggest that, besides other mechanisms potentially involved, the central foveal retinal activity might be involved in the mechanism of myopia control with these lenses.

Comparison of Visual Acuity and Defocus Curve after Cataract Surgery with Pure Extended Depth Focus Lens and Mini-Monovision - Interim Analysis -

Abstract&#x0D; Introduction &amp; Objectives : Presbyopia after cataract surgery is still a problem despite recent surgical techniques and intraocular lens technology development. Mini-monovision techniques and pure extended depth of focus (EDoF) lenses are alternatives to achieve good distance and intermediate visual acuity at relatively inexpensive.This study aims to compare the clinical outcome after cataract surgery with binocular mini-monovision and cataract surgery using a pure monocular EDoF lens.&#x0D; Methods : Subjects were randomized into the mini-monovision group (standard monofocal lenses with -1.25 D of anisometropia) and the pure EDoF group. The blinding was achieved by masking the clinical outcome examiners.&#x0D; Results : Interim analysis of 16 patients revealed the outcome of uncorrected and corrected distance visual acuity (UCDVA and BCDVA) were not significantly different between groups. Median of uncorrected intermediate visual acuity (UIVA) and mean of uncorrected near visual acuity (UNVA) of binocular mini-monovision were 0.10 (0-0.10) LogMar and 0.26 + 0.12 LogMar. Median UIVA &amp; mean UNVA monocular EDoF were 0.19 (0.14-0.50) LogMar and 0.54 + 0.11 LogMar, respectively. The Mann- Whitney U test of UIVA between groups revealed p=0.001, and the unpaired T-test of UNVA revealed p=0.000. Mean defocus curve of -2.50 D lens were 0.31 LogMar in binocular mini- monovision group and 0.51 LogMar monocular in EDoF group (p=0.019).&#x0D; Conclusion : UIVA, UNVA and defocus curve of -2.50 D lens in the mini-monovision group were better than the EDoF group.

Tolerance to induced astigmatism of patients with trifocal or extended depth of focus intraocular lens implantation.

Residual astigmatism is common after cataract surgery involving implantation of an intraocular lens, yet the tolerance of presbyopia-correcting intraocular lens to astigmatism of different magnitudes and axes is poorly understood. Here we compared visual acuity and quality in the presence of induced astigmatism after implantation of a trifocal or extended-depth-of-focus (EDOF) intraocular lens, the two widely used presbyopia-correcting intraocular lenses. At least 3 months after implantation of a TFNT00 or ZXR00 intraocular lens, patients were analyzed by slit-lamp examination, non-contact tonometry, subjective refraction, iTrace aberrometry, and corneal topography. After correction of residual astigmatism, astigmatism of different magnitudes on different axes was induced using cylindrical lenses, and overall visual acuity was measured, while objective visual quality was measured using the Optical Quality Analysis System II. Subjects were also asked about subjective visual quality using the Visual Function-14 questionnaire. Comparison of 18 individuals who received a trifocal lens and 19 who received an EDOF lens showed that objective visual quality was better in the EDOF group regardless of the magnitude or axis of the induced astigmatism. In both groups, astigmatism of at least -1.00 DC influenced distant vision more severely when the axis was 45° than 0° or 90°, meanwhile astigmatism of at least -1.50 DC influenced near and intermediate vision more severely when the axis was 45° than 0° or 90°. Trifocal or EDOF intraocular lenses are less tolerant of oblique astigmatism than astigmatism with or against the rule. EDOF lenses may provide better objective visual quality than trifocal lenses in the presence of astigmatism, regardless of its magnitude or axis.

Soczewki EDOF – najnowocześniejsza soczewka do korekcji starczowzrocznośc

Presbyopia is physiological process in which due to aging of the eye there is a loss of accommodation that results in worsening of clear vision over close objects. This condition can be treated with glasses, contact lenses, laser refractive surgery or refractive lens extraction. Latter treatment option comprises of implantation of multifocal and extended depth of focus lenses. Extended depth of focus lenses in contrast to multifocal lenses (produce multi plefocal points) create single elongated focal point which in turn aids to reduce most common photic effects. Aim of this article is to explain the difference between multifocal and extended depth of focus lenses as well as differentiate types of extended depth of focus lenses lenses available on the Polish market.

Effect of myopia management contact lens design on accommodative microfluctuations and eye movements during reading

BackgroundSoft contact lenses have been developed and licensed for reducing myopia progression. These lenses have different designs, such as extended depth of focus (EDOF) and dual focus (DF). In this prospective, double-masked, cross-over study, different lens designs were investigated to see whether these had impact on accommodative microfluctuations and eye movements during reading. MethodsParticipants were fitted with three lenses in a randomised order; a single vision (SV) design (Omafilcon A2; Proclear), a DF design (Omafilcon A2; MiSight), and an EDOF lens design (Etafilcon A; NaturalVue),. Accommodative microfluctuations were measured at 25 cm for at least 60s in each lens, using a Shin-Nippon SRW-5000 autorefractor adapted to continuously record accommodation at 22Hz. Eye movement data was collected with the Thomson Clinical Eye Tracker incorporating a Tobii Eye bar. Eye movements include fixations per row, fixations per minute, mean regressions per row, total number of regressions, and total rightward saccades. Accommodation data was analysed using power spectrum analysis. Differences between the lenses were compared using a related sample two-way Friedman test. ResultsTwenty-three participants (18–29 years) were recruited to take part. The average mean spherical error was −2.65D ± 1.42DS, with an average age of 23.4 ± 3.5 years. No significant difference for accommodative microfluctuations was found. Significant differences were found for fixations per row (P = 0.03), fixations per minute (P = 0.008), mean regressions per row (P = 0.002), and total number of regressions (P = 0.002), but not total rightward saccades (P = 0.10). Post-hoc analysis indicated the EDOF lens results were significantly different from the other lenses, with more regressive eye movements observed. ConclusionsRegressive saccades appear to increase when wearing EDOF lens designs, which may impact visual comfort. Further studies in children, over a longer period of adaptation are necessary to assess the potential impact of this finding on daily reading activities in children.

Pros and Cons of soft contact lens power mapping

Purpose. To provide an overview of currently available meth- ods and instruments for the measurement of soft contact lens power maps, together with their advantages and potential shortcomings. Material and Methods. The three leading measurement prin- ciples of Moiré Fringe, Shack-Hartmann and Phase Shifting Schlieren were identified, and the relevant literature reviewed and technical specifications summarised. To demonstrate some of the potential deficiencies associated with optical power mapping, a series of measurements were conducted on toric, multifocal and extended depth of focus lenses, using one representative instrument. Raw measured data were analysed using various analysis tools and parameters. Results. Power maps and power profiles are presented for the various lens types. Different smoothing filter settings resulted in significantly different power profiles near the optical centre. The ‘Power versus Azimuth’ profiles showed unexpected results. Conclusion. While all three methods are generally reliable and easy to use, there are still some limitations which need to be considered when interpreting the results. In particular, the profile filter settings need to be chosen carefully for multifocal and extended depth of focus lenses. The need for accurate refractive index data for lens material and solution was demonstrated. Keywords Soft contact lenses, power maps, power profiles, Moiré Fringe, Shack-Hartmann, Phase Shifting Schlieren

Refractive extended depth-of-focus lens design based on periodic power profile for presbyopia correction.

Limitations of existing diffractive multifocal designs for presbyopia correction include discrete foci and photic phenomena such as halos and glare. This study aimed to explore a methodology for developing refractive extended depth-of-focus (EDoF) lenses based on a periodic power profile. The proposed design technique employed an optical power profile that periodically alternated between far, intermediate and near distances across the pupil radius. To evaluate the lens designs, optical bench testing was conducted. The impact on visual performance was assessed using a spatial light modulator-based adaptive optics vision simulator in human subjects. Additionally, the effects of pupil size change and lens decentration on retinal image quality were examined. A comparative performance analysis was carried out against a typical diffractive trifocal design and a monofocal lens. The proposed design method was found to be effective in uniformly distributing light energy across all object distances within the desired depth of focus (DoF). While trade-offs between overall image quality and DoF still exist, the EDoF lens design, when tested in human subjects, provided a continuous DoF spanning over 2.25 D. The results also revealed that the EDoF design had a slightly higher dependence on changes in pupil size and lens decentration than the diffractive trifocal design. The proposed design method showed significant potential as an approach for developing refractive EDoF ophthalmic lenses. These lenses offer a continuous DoF but are slightly more susceptible to variations in pupil size and decentration compared with the diffractive trifocal design.

The utility of extended depth-of-focus intraocular lens in the management of higher-order aberrations and modulation transfer function in a case of Alport syndrome

This report describes the changes in the higher-order aberrations (HOAs) and modulation transfer function (MTF) in anterior lenticonus in a case of Alport syndrome managed by using extended depth of focus (EDOF) IOL. The patient was a 23-year-old male complaining of diminution of vision in both eyes and had a best-corrected visual acuity (BCVA) of 6/24 and 6/18 in the right and left eye, respectively. Slit-lamp examination revealed anterior lenticonus in both eyes. Optical coherence tomography showed temporal retinal thinning, and aberrometry revealed increased HOA and a reduction of MTF. The patient underwent sequential, bilateral, clear corneal phacoemulsification with EDOF IOL implantation. Postsurgery, improvements in BCVA and MTF with a significant reduction in HOA were noted. To conclude, the EDOF lens is a viable option for implantation in cases of Alport syndrome with anterior lenticonus.

How Reliable Is Pyramidal Wavefront-Based Sensor Aberrometry in Measuring the In Vivo Optical Behaviour of Multifocal IOLs?

Cataract or refractive lens surgery, along with the implantation of multifocal intraocular lenses (MF-IOL), enables a complete range of functional far, near and intermediate vision. Refractive, diffractive and extended depth of focus (EDoF) or combination of these principles represent the technology used to obtain this multifocality. Aberrometry makes it possible to study the aberrations induced by MF-IOLs. Among the different optical principles available to measure ocular aberrations, pyramidal wavefront-based sensor (PWS) aberrometry shows the highest resolution with MF-IOLs. Retinal image quality measured by a PWS aberrometer differed significantly according to the technology of the implanted lens. Monofocal and diffractive lenses showed the highest values of far-distance retinal image quality, followed by refractive and EDoF lenses; however, retinal image quality analysed in diffractive lenses appears to be more dependent on residual refractive error. Considering this limitation, PWS-aberrometry could be used to compare diffractive lenses. Nevertheless, further studies are needed to provide additional information about the clinical retinal image quality of MF-IOLs and to help surgeons in the important preoperative selection of IOLs.

Positioning of enhanced monofocal intraocular lenses between conventional monofocal and extended depth of focus lenses: a scoping review

BackgroundNew intraocular lenses (IOLs) have emerged since the originally coined monofocal and multifocal IOLs. The extended depth of focus (EDoF) and enhanced monofocal IOLs (mono-EDoF) that have appeared in the last decade have caused some confusion in their classification. The aim of this review was to summarize the outcomes provided by mono-EDOF IOLs and to determine which of the endpoints, described by the American National Standard (ANSI) for EDoF IOLs, are fulfilled.MethodsThe MEDLINE, EMBASE, and WEB OF SCIENCE databases were searched. Two independent reviewers screened the studies for inclusion and data extraction. The search strategy was limited to studies published between 2020 and 2022, but not by language. The results are presented as a narrative summary accompanied by tables, in alignment with the objectives of this scoping review. Compliance with the endpoints for clinical outcomes described in the American National Standard Z80.35–2018 (ANSI) for EDoF lenses was checked and additional endpoints were defined.ResultsTwo systematic reviews, 13 laboratory, 21 clinical, and two mixed studies were included. Tecnis Eyhance was the mono-EDOF with the highest volume of evidence to date. Although laboratory studies included other IOLs, clinical evidence for them is still scarce, with only one study of IsoPure compared to a standard monofocal IOL. Evidence in comparison to EDoF lenses is also scarce, even for Tecnis Eyhance, with only three studies including this lens in comparison to an EDoF lens. After evaluation of the ANSI criteria, agreement was found in the failure for the increase in depth of field equal to or greater than 0.5 D for a visual acuity (VA) level of 0.2 logMAR and none of the studies supported that the median monocular VA at intermediate distance was at least 0.2 logMAR.ConclusionsAdditional clinical evidence is required for other mono-EDOF IOLs beyond Tecnis Eyhance. Until the arrival of a standard classification, mono-EDOF should be better still classified as monofocal because the ANSI standards were not fully met.

Rotational stability and refractive outcomes of the DFT/DATx15 toric, extended depth of focus intraocular lens

PurposeTo quantitatively assess postoperative rotational stability and visual acuity with the DFT/DATx15 extended depth of focus (EDOF) toric intraocular lens (IOL).MethodsIn this prospective case series, thirty-five patients with a calculated IOL power between + 15.0 D and + 25.0 D, corneal astigmatism between 0.75 D and 2.25 D, and no significant ocular pathology underwent cataract surgery. Primary outcome was rotational stability of the IOL at 1 month post-operatively. Secondary outcomes included residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.ResultsMean absolute postoperative IOL rotation was 1.1 ± 0.2 degrees, with no rotation of more than 3 degrees at the final visit. Monocular mean best spectacle-corrected distance visual acuity (BSCDVA) improved from logMAR 0.27 ± 0.030 to 0.078 ± 0.017 (P < .001). Monocular uncorrected distance visual acuity (UCDVA) improved from 0.93 ± 0.096 to 0.18 ± 0.022 (P < .001). Best spectacle-corrected intermediate visual acuity (DSCIVA) was 0.17 ± 0.025, and uncorrected intermediate visual acuity (UCIVA) was 0.27 ± 0.040. Residual regular astigmatic refractive error was 0.21 ± 0.047 D.ConclusionsThe toric DFT/DATx15 EDOF lens showed excellent rotational stability and effective and predictable correction of astigmatism. Its refractive outcomes and safety profile were similar to those identified in prior studies of the non-toric DFT/DAT015 EDOF IOL. A small difference in monocular BSCDVA, of uncertain clinical significance, was found when comparing these outcomes with prior DFT/DAT015 data. The trial was retrospectively registered on November 5, 2021 (TRN ​​NCT05119127).

Latest Development in Extended Depth-of-Focus Intraocular Lenses: An Update.

In recent years, there has been an overwhelming influx of different types of intraocular lenses (IOLs) as treatment for presbyopia. The extended depth-of-focus (EDOF) technology creates a single elongated focal point to enhance depth of focus, in contrast to the multiple foci of multifocal (MF) lenses. In this way, the EDOF lenses aim to reduce photic phenomena, glare, and halos, which have been reported in MF IOLs. A potential disadvantage of this is a blur due to decreased retinal image quality when the amount of the aberrations is increased excessively. Multifocality and EDOF characteristics are not exclusive of each other. Frequently, EDOF IOLs are combined with MF optical designs, a bifocal IOL may exhibit EDOF characteristics, likewise an aspheric monofocal IOL or a diffractive or refractive trifocal IOL. Thus, EDOF lenses are commonly subjected to confusion. A wide range of different types of EDOF lenses are available on the market to surgeons. In this practical update, we aim to clarify what is a true EDOF lens, classify the different types of the EDOF lenses based on their optical principle and review their recently reported outcomes. Comprehensive patient examination and selection, combined with knowledge of the most updated options and adequate patient counseling, can avoid dissatisfaction and yield the desired outcomes.

Evaluation of Visual and Patient-Reported Outcomes, Spectacle Dependence after Bilateral Implantation with a Non-Diffractive Extended Depth of Focus Intraocular Lens Compared to Other Intraocular Lenses.

Purpose: To evaluate postoperative outcomes, spectacle dependance and the occurrence of the photic phenomena in patients after cataract surgery following the implantation of a non-diffractive extended depth of focus (EDOF) intraocular lens was compared to monofocal and multifocal lenses. Methods: We enrolled patients with bilateral cataracts who wanted to reduce their dependence on glasses in the study. They were followed for 6 months. The study group in which the EDOF lens was implanted consisted of 70 eyes in 35 patients. The control groups consisted of: 52 eyes in 26 patients in whom a multifocal was implanted and 52 eyes in 26 patients with implanted monofocal lens. After a total of 2 weeks, 2 months and 6 months post-surgery the following were evaluated: uncorrected and corrected visual acuity at 4 m, 80 cm, 40 cm, manifest refraction expressed as mean refractive spherical equivalent (MRSE), contrast sensitivity, intraocular pressure. A questionnaire on independence from ocular correction, the occurrence of photic phenomena, and patient satisfaction was also completed. Results: Monocular and binocular visual acuity and MRSE 6 months after the procedure were compared between three groups. All of the main analyses, except for comparisons of uncorrected distance visual acuity (both monocular and binocular) level, were significant. Contrast sensitivity was lower among patients with multifocal lens than among patients with EDOF lens. Halo and glare after 6 months were seen more often among patients with multifocal lens than among patients with the other lens (65% of eyes with multifocal lens vs. 6% of eyes with EDOF lens and 0% of eyes with monofocal lens). Glasses were needed by 35% of patients with EDOF lens, and by 96% of patients with monofocal lens and in none of the patients with multifocal lens. Conclusions: Most patients qualify for the implantation of a non-diffractive EDOF lens. Post-operative visual acuity improves at any distance. The best monocular visual acuity for intermediate distances is provided by an EDOF lens, and for near distance by a multifocal lens. The EDOF lens definitely increases independence from spectacle correction compared to monofocal lenses; however, the greatest degree of independence from spectacles is provided by multifocal lenses. The incidence of photic phenomena is slightly higher than that of a monofocal lens, and much lower for a multifocal lens.

Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial.

IntroductionThis study aimed to assess the safety and efficacy of a novel extended-depth-of-focus (EDOF) soft contact lens for myopia control in children.MethodsA prospective, multicenter, randomized, double-masked, placebo-controlled, contralateral-eye comparison clinical trial was conducted in 72 children (40 male and 32 female) aged 9 to 14 years, with each eye randomly selected to wear either an experimental EDOF contact lens or a single-vision control lens at least 8 h per day, 5 days a week, for 52 weeks. Each contact lens was worn and then replaced daily. Measurements including best-corrected visual acuity, spherical equivalent refractive error (SER), axial length (AXL), and keratometry were performed at weeks 1, 4, and 13, and every 13 weeks thereafter for 52 weeks. The primary outcome measure was the change in SER, measured using cycloplegic auto-refraction. The secondary outcome measure was the change in AXL.ResultsAt week 52, the mean change in SER was significantly lower with the experimental lens (−0.70 ± 0.49 D) than with the control lens (−0.88 ± 0.51 D; P < .001). The mean AXL elongation was significantly lower with the experimental lens (0.34 ± 0.19 mm) than with the control lens (0.38 ± 0.19 mm; P < .001). The EDOF lens reduced AXL and myopia progression by 10.5% and 20.5%, respectively. The change in SER, but no AXL, was significantly associated with EDOF lens wear in adjusted multivariate regression analysis. Reported adverse events did not differ significantly between the two lens types.ConclusionsThe results of this 1-year clinical trial demonstrate that the experimental EDOF soft contact lens slows myopia progression and reduces AXL elongation in children compared with a single-vision contact lens. (This study was retrospectively registered with ClinicalTrials.gov; identifier: NCT04238897; date of registration: January 23, 2020.)

Refractive error impact on visual acuity of presbyopic patients with EDOF contact lenses

Purpose: The purpose of this study was to evaluate the impact that refractive error (myopia or hyperopia) has on visual acuity in a presbyopic population using Extended Depth of Focus lenses (EDOF) with high addition.

Polychromatic through-focus image quality in a wavefront-shaping presbyopia correcting intraocular lens

ABSTRACT Objectives To compute the polychromatic through-focus image quality in eyes implanted with a new extended depth of focus (EDOF) intraocular lens (IOL). Methods Eight eyes of four patients who underwent implantation with the AcrySof IQ Vivity EDOF IOL were analyzed. Wavefront aberrations were measured. The optical metric for the polychromatic through-focus image quality used was the Visual Strehl ratio computed in the spatial domain (VSX). Eight eyes implanted with a monofocal IOL were also examined. Results The normalized VSX values change with vergence for both group of IOLs. However, the depth-of-focus (DoF) for the Vivity IOL was about 0.75, 1.00, and 1.25 D larger than the monofocal IOL, for 0.1, 0.2, and 0.3 logMAR visual acuities. The DoF computed from the polychromatic through-focus image quality for the Vivity IOL was about 2.50D, being this value 1.25D wider than the monofocal one. The DoF obtained from the defocus curve was about 2.25 D for eyes implanted with the Vivity IOL. Conclusions Polychromatic through-focus image quality analysis agrees with the clinical outcomes indicating that this methodology may be useful to estimate the DoF and the expected quality of vision in patients implanted with lenses from wavefront aberration measurement. This approach shows the increased DoF of the EDOF lens compared to a monofocal.

Multifocal and Accommodating Intraocular Lenses for the Treatment of Presbyopia: A Report by the American Academy of Ophthalmology

To review the published literature assessing the efficacy and safety of presbyopia-correcting intraocular lenses (IOLs) for the treatment of presbyopia after cataract removal. Literature searches were undertaken in January 2018 and September 2020 in the PubMed, Medline, and Cochrane Library databases. This yielded 761 articles, of which 34 met the criteria for inclusion in this assessment and were assigned a level of evidence rating by the panel methodologist. Thirteen studies were rated level I and 21 studies were rated level II. Presbyopia-correcting lenses were effective at improving distance and near visual acuity after cataract surgery. Near acuity at different focal lengths was related directly to the effective add power of multifocal and extended depth-of-focus (EDOF) IOLs. Most multifocal and EDOF lenses that were compared with a control monofocal lens demonstrated that patient-reported spectacle independence was superior to the monofocal lens. All patients who had multifocal and EDOF lenses implanted showed decreased contrast sensitivity and reported more visual phenomena as compared with control participants who received monofocal lenses. Presbyopia-correcting lenses improve uncorrected near and distance visual acuity and decrease spectacle dependence after cataract surgery. Mesopic contrast sensitivity is decreased compared with monofocal lenses, and patient-reported visual phenomena are more likely in patients receiving multifocal or EDOF lenses.

The Latest Evidence with Regards to Femtosecond Laser-Assisted Cataract Surgery and Its Use Post 2020.

Femtosecond laser-assisted cataract surgery (FLACS) was introduced with the hope of making cataract surgery safer and making the refractive result more predictable. It is only in the last four years that level 1 prospective randomised controlled trials (RCT) using current technology have been published. These, along with a meta-analysis of recent studies have shown that there seems to be little long-term visual benefit when using FLACS with monofocal lenses. The promised decrease in ultrasound energy required to remove a cataract has not been consistently demonstrated. There is level one evidence that the rate of posterior capsular rupture is less with FLACS using modern software. The round capsulotomy may be of increasing importance with the uptake of toric, multifocal and extended depth of focus lenses where a predictable capsulotomy size and precise placement of the lens becomes more important.

Multifocal and Extended Depth of Focus Intraocular Lenses: A Comparison of Data from the United States Food and Drug Administration Premarket Approval Trials.

To review and compare the results of unpublished premarket approval studies for recent multifocal and extended depth of focus (EDOF) intraocular lenses. Lenses without previously published pre-market approval trials were identified and clinical and patient-reported outcomes were reviewed and compared. Lenses included the DFT/DAT (Acrysof Vivity) EDOF lens, the TFNT/TFAT (PanOptix) trifocal lens, and the SV25T (ReStor ActiveFocus) lens (all from Alcon Laboratories, Inc), as well as the ZXR/ZXT (Tecnis Symfony and Symfony Toric), the ZLB00 (Tecnis Multifocal +3.25), and the ZKB00 (Tecnis Multifocal +2.75, all Tecnis lenses from Johnson & Johnson Vision). All lenses produced equivalent distance vision and superior intermediate and near vision compared to monofocal controls. Patient-reported difficulty with glare, halos, and starbursts was higher in the multifocal and EDOF lens cohort compared to monofocal controls. Spectacle independence was higher in the multifocal and EDOF cohort with the exception of the SV25T (ActiveFocus) lens, which was not significantly different than the control lens. Clinical trial data from the U.S. Food and Drug Administration premarket approval studies supports multifocal and EDOF lenses as an effective treatment for aphakia and presbyopia. [J Refract Surg. 2021;37(2):98-104.].

Visual Acuity, Quality of Vision, and Patient-Reported Outcomes After Bilateral Implantation with a Trifocal or Extended Depth of Focus Intraocular Lens.

PurposeTo evaluate the visual acuity, quality of vision and patient reported outcomes for patients that were either bilaterally implanted with a trifocal intraocular lens (IOL) or an extended depth of focus (EDOF) IOL.DesignSingle site, prospective, non-interventional, masked, two-arm comparative study.MethodsSubjects who had prior uncomplicated cataract surgery with bilateral implantation of one of the lenses above were evaluated. Subjects in each group were assessed during a single visit. The uncorrected and best distance-corrected binocular near (40 cm), intermediate (60 cm), and distance visual acuity (VA) were measured, along with a spectacle independence questionnaire, a quality of vision questionnaire and contrast sensitivity measured in both mesopic and photopic conditions.ResultsThe study included 23 EDOF and 25 trifocal subjects. Binocular Uncorrected VAs were similar at distance and intermediate, but about 1.5 lines better at near with the trifocal (p < 0.001). Binocular best corrected distance – VA was significantly better with the EDOF lens (0.5 lines, p < 0.001), though the mean VA was better than 20/20 in both groups. Distance-corrected intermediate and near VA were significantly better with the trifocal IOL (1 line and 1.5 lines respectively, p < 0.001). Significantly more trifocal subjects had 20/25 or better VA at all three test distances (64% vs 4%, p<0.001). Patient reported spectacle independence was significantly higher in the trifocal group, driven primarily by differences in near vision. Mesopic and photopic binocular contrast sensitivity, satisfaction and subjective quality of vision scores were similar between groups.ConclusionThe trifocal IOL provided significantly better near vision (1.5 lines) with slightly worse distance vision (0.5 lines), while providing similar contrast sensitivity and visual quality. It may be the preferred choice for patients desiring more spectacle independence.