Category: 4. Technology

  • Clinical Outcomes of a Multicenter Study Following Implantation of an

    Clinical Outcomes of a Multicenter Study Following Implantation of an

    Introduction

    The advances in cataract surgery in terms of techniques, instruments and intraocular lenses (IOL) has led to a great improvement in quality of life and vision for patients. In addition, presbyopia correcting or high performance IOLs have minimised spectacle dependence for some daily activities, especially those involving intermediate and near vision. Trifocal IOLs create three focal points to provide good outcomes at far, intermediate and near distances, while extended-depth-of-focus (EDOF) IOLs create a continuous area of focus, optimising intermediate vision. A systematic review and meta-analysis based on 22 publications enrolling 2200 eyes compared the outcomes of trifocal IOLs and EDOF IOLs in patients undergoing IOL implantation after cataract surgery and refractive lens exchange.1 This study concluded that trifocal lenses improved near visual acuity compared to EDOF IOLs but no difference was reported in terms of far and intermediate visual acuity. Specifically, when the defocus curve was analysed, the trifocal lenses showed favourable outcomes for near vision, whereas the EDOF lenses had better results for intermediate vision. EDOF IOLs are a new approach in the armamentarium available to cataract and refractive surgeons. Also, new IOLs, namely advanced monofocal or monofocal plus or enhanced monofocal lenses, have been launched onto the market that provide a relatively good depth of focus although this is not comparable to that produced by EDOF IOLs.

    The Isopure Serenity IOL (BVI, Inc., Waltham, USA) is a lens recently launched onto the market with an optical aspheric design based on an isofocal concept.2 This IOL is identical to the Isopure 1.2.3 IOL except for the haptic-design, which has a double C-loop posterior angulated haptic platform. This POD platform is used in other IOL models from the same company. Over the last 5 years, a number of clinical studies have analysed the Isopure 1.2.3 IOL, reporting good outcomes in terms of refraction, visual acuity, optical quality, photic phenomena and patient-reported questionnaires.3–15 These studies analysed samples containing from 22 up to 183 eyes with follow-up periods from 1 to 12 months. Taking into account these studies, we consider that this lens is an effective choice for our patients and provides them with good vision at far distance and functional intermediate vision due to the extended-range of vision created. The purpose of this multicentre study is to analyse the refractive accuracy and vision at different distances in subjects implanted with the new Isopure Serenity IOL.

    Methods

    This is a multicentre-prospective open-label clinical study. The study was carried out in accordance with the tenets of the Declaration of Helsinki and was approved by each of the local Review Boards (IRB) of the different centers participating in the study: Centre For Sight, Nihonbashi Cataract-Clinic, Institut Ophtalmologique de l’Ouest Jules Verne, Centre Ophtalmologique Kléber, Clinique Beau Soleil, Hospital CHU Ambroise Paré, IRCCS Humanitas Research Hospital and Università degli studi di Milano. Patients signed informed consent to participate in the study. The inclusion criteria considered patients aged 45 years or older on the treatment day that were bilaterally implanted with Isopure Serenity IOLs, with a maximum time of 30 days between the first and second eye treatment. The exclusion criteria considered patients who had undergone previous intraocular surgery, diagnosed with degenerative visual disorders such as age-related macular degeneration or cystoid macular oedema, patients for whom in-the-bag implantation was not possible, and patients who experienced surgical complications (eg, posterior capsule rupture).

    Isopure Serenity Intraocular Lens

    All the eyes in this study were implanted with the posterior chamber hydrophobic Isopure Serenity IOL (non-toric or toric model PODS49P/PODST49P, Figure 1). This IOL model is made of GFY material (hydrophobic acrylic with refractive index of 1.53 and an Abbe number of 42, with blue light and UV filters). The IOL, with optical and overall diameters of 6.00 mm and 11.4 mm, respectively, has a posterior angulated POD double C-loop haptic platform with RidgeTech. The RidgeTech wavy structures are prone to limit the problematic of the mutual attachment of the two trailing haptics during lens implantation with standard injection systems. The IOL is manufactured in spherical powers ranging from +10 D to +30 D (0.50 D steps) and from +31 D to +35 D (1.00 D steps); the cylindrical power (IOL plane) is manufactured for the following powers: 1.00/1.50/2.25/3.00/3.75/4.50/5.25/6.00 D. The Medicel Accuject 2.1/2.2 injection system is employed to implant the IOL model. Swept-source optical biometry with the IOL Master 700 (Carl Zeiss Meditec, Jena, Germany) and Anterior (Heidelberg Engineering GmbH, Heidelberg, Germany) devices was employed with the Barrett-Universal II, Barrett TK and Holladay 2 formulas.

    Figure 1 Posterior chamber hydrophobic Isopure Serenity intraocular lens. Left: lens design with sizes; right: photography.

    Refraction Accuracy and Visual Performance at Different Distances

    All the data was recorded at least 3 months post-surgery. Refraction was recorded in all the eyes. Vector analysis was carried out using the double-angle plot tool.16 For visual performance, the monocular-uncorrected-distance-visual acuity (UDVA), corrected-distance-visual acuity (CDVA), uncorrected-intermediate-visual acuity (UIVA), distance-corrected-intermediate-visual acuity (DCIVA) both at 80 cm and 66 cm, uncorrected-near-visual acuity (UNVA), and distance-corrected-near-visual acuity (DCNVA) at 40 cm were measured. In addition, binocular photopic defocus curves were measured from +1.00 D to –4.00 D (25 cm) in 0.5 D steps. Any possible adverse event was registered.

    The information recorded from all the subjects was registered into an Excel spreadsheet (Microsoft Corporation, Redmond, USA) to provide mean, standard deviation and ranges for all the variables studied. In addition, several graphs to report standard outcomes after IOL surgery were created.17

    Results

    In this multicentre clinical study, 108 eyes (54 subjects) were implanted with the Isopure Serenity IOL. Table 1 shows the patient demographics and preoperative main characteristics. Specifically, the average age of the subjects was 72.13±8.60 years (from 47 to 88 years); and 39 patients were female. The average IOL power was +21.40±3.85 D, ranging from +10.00 to +29.00 D. No related adverse IOL events were reported.

    Table 1 Demographic Characteristics of Participants Shown as Means, Standard Deviations (SD) and Ranges

    Refractive Outcomes

    Figure 2 plots the refractive accuracy of the surgery for the postoperative spherical equivalent refraction (A) and the refractive cylinder (B). In our cohort, 79.63% of eyes were within ±0.50 D and 98.15% of eyes were within ±1.00D of the target spherical equivalent. In relation to refractive astigmatism, 72.22% and 96.30% of eyes showed a refractive cylinder of ≤0.50 D and ≤1.00 D, respectively. The average refractive spherical equivalent and cylinder values were –0.06±0.44 D and –0.37±0.44 D, respectively. Vector analysis was performed; Figure 3 shows the outcomes for preoperative corneal astigmatism prior to the surgery (Figure 3A) and the postoperative refractive astigmatism post-IOL implantation (Figure 3B). Note that the mean absolute of the corneal astigmatism before IOL implantation was 0.63±0.35 D and that of the refractive cylinder was 0.38±0.43 D after the intervention, showing its postoperative reduction.

    Figure 2 Distribution of postoperative spherical equivalent refraction (A) and refractive cylinder (B) post-Isopure Serenity intraocular lens implantation.

    Figure 3 Double-angle plots for preoperative corneal astigmatism (A) and postoperative refractive astigmatism (B) post-Isopure Serenity intraocular lens implantation. Centroids, mean absolute values with standard deviations, 95% confidence ellipse of the centroid and 95% confidence ellipse of the dataset are also shown.

    Far, Intermediate and Near Visual Acuity Outcomes

    For visual acuity outcomes, Figure 4 was plotted. This figure plots the cumulative percentage of eyes post-surgery with given UDVA and CDVA (Figure 4A), UIVA and DCIVA (Figure 4B), and UNVA and DCNVA (Figure 4C) values. We can see that 68.41% and 98.15% of eyes showed a UDVA and CDVA of 20/20 or better, respectively, with 88.89% and 99.07% of eyes achieving a UDVA and CDVA of 20/25 or better, respectively (see Figure 4A). Specifically, the average values for UDVA and CDVA were 0.02±0.11 logMAR and –0.04±0.05 logMAR, respectively. Mean visual acuities are illustrated in Table 2 (note that some values were not recorded for the whole sample). For intermediate vision, Figure 4B shows that 77.14% and 39.39% of eyes achieved a DCIVA of 20/32 or better at 80 cm and 66 cm, respectively, and 90% and 72.73% eyes achieved a DCIVA of 20/40 or better at 80 and 66 cm, respectively. The average values for DCIVA were 0.19±0.10 and 0.28±0.11 logMAR, at 80 cm and at 66 cm, respectively (see Table 2, which also shows the mean values for UIVA). At near distance (40 cm), Figure 4C shows that 25% and 15.15% of eyes had a UNVA and DCNVA of 20/32 or better, respectively, with 39.81% and 31.82% achieving a UNVA and DCNVA of 20/40 or better, respectively. The average values for UNVA and DCNVA were 0.37±0.15 logMAR and 0.40±0.13 logMAR, respectively (see Table 2).

    Table 2 Monocular Visual Acuity Outcomes (logMAR) for Eyes Implanted with the Isopure Serenity Toric Intraocular Lens (IOL) Shown as Means, Standard Deviations (SD) and Ranges at 3 months of Follow-Up

    Figure 4 Cumulative proportion of eyes post-Isopure Serenity intraocular lens implantation with a given postoperative uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) (A), uncorrected intermediate visual acuity (UIVA) and distance-corrected intermediate visual acuity (DCIVA) at 80 and 66 cm (B), and uncorrected near visual acuity (UNVA) and distance-corrected visual acuity (DCNVA) at 40 cm (C).

    Defocus Curve

    Figure 5 plots the photopic binocular through-focus, best-corrected visual acuity from +1.0 D to –4.0 D in the whole cohort. Note that there is a peak of best visual acuity (–0.05±0.06 logMAR) at far distance focus of the IOL, ie, 0 D of vergence, with its value reducing with increased lens power, showing a broad range of functional vision from far distance down to vergences of around 1.75 D (with reference to 0.20 logMAR). This figure also shows binocular values from different studies3,5,8,9 with the Isopure 1.2.3 IOL illustrated for comparative purposes. It should be considered that these values were estimated from the different graphs published in their respective studies.

    Figure 5 Mean photopic binocular logMAR visual acuity with best correction for distance as a function of the chart vergence from +1.0 D to –4.0 D post-Isopure Serenity intraocular lens (IOL) implantation. The error bars represent the standard deviation. The right y-axis shows Snellen acuity in feet. Distance (cm) is shown in the upper x-axis for intermediate distances. Binocular values from different studies with the Isopure 1.2.3. IOL are depicted for comparative purposes. Note that these values were estimated from the graphs published in the different studies. All the curves were smoothed for graphical representation.

    Discussion

    Some clinical publications have reported the visual and refractive outcomes of eyes implanted with the Isopure 1.2.3 IOL,3–15 reporting good visual performance for this lens at different distances and excellent refractive accuracy when implanted. The objective of this multicentre-study was to analyse the visual and refractive outcomes in a cohort of eyes implanted with the new model, the Isopure Serenity IOL, which uses 4 C loop haptics as opposed to 4 closed loop haptics with the prior model.

    Refractive Accuracy

    A key indicator of IOL performance is the predictability of the postoperative refractive outcome. Figure 2 plots the accuracy for the spherical equivalent and cylinder at the last postoperative visit for our sample. The percentage of eyes within ±1.00 D of the spherical equivalent and ≤1.00 D of the refractive cylinder were high: 98.15% and 96.30%, respectively. Spherical equivalent outcomes were excellent (–0.06±0.44 D) as was mean refractive astigmatism (–0.37±0.44 D). The reduction of refractive astigmatism is evident with the scatter plot (Figure 3) revealing a centroid mean of 0.20±0.54D. By contrast, EUREQUO outcomes, which analysed more than 280,000 cataract and refractive procedures, reported 72.7% of eyes as being within ±0.50D and 93% of eyes within ±1.00D.18 In order to compare our outcomes with previous publications using the Isopure 1.2.3 IOL, we created Table 3. This table indicates some studies that published refractive and visual outcomes based on a minimum of number of eyes and follow-up times (40 eyes and 3 months of follow-up). Bova and Vita4 recruited the smallest sample of eyes (n=42) and Bernabeu-Arias et al5 the largest (n=183). Bova and Vita4 published outcomes with the longest follow-up period (1 year). Our results largely agree with those found by other colleagues for the Isopure 1.2.3. IOL. For example, we obtained, together with Ang et al8 the lowest mean spherical equivalent value (–0.06 D), with the refractive astigmatism being similar to that recorded in other studies, between a quarter to close to half of a dioptre. The number of eyes with a spherical equivalent within ±0.50 D and ±1.00 D were similar to those found by our colleagues (from 73.2%5 to 84.62%,8 and 95.7%5 and 99.23%,8 respectively). This was also similar for the refractive astigmatism ≤0.50D and ≤1.00D: Ang et al8 found 74.6% and 96.2%, respectively. Perez-Sanz et al19 analysed the tolerance of residual astigmatism of the Isopure 1.2.3 IOL with comparison to the monofocal Micropure IOL (BVI Inc). They found that the performance of the two models was quite similar for 2- and 3-mm pupils, while the Isopure exhibits a significant reduction in optical quality for a 4.5-mm pupil in comparison with the monofocal lens. However, no statistically significant differences were reported between the lenses when visual performance was examined for any power of induced astigmatism. They concluded that the tolerance to residual astigmatism for the Isopure model was similar to that of the monofocal Micropure lens with a pupil of up to 3.5-mm. They reported that tolerance was worse for the Isopure when the residual astigmatism was induced at 90° versus 180°. Based on our results, we consider that the performance of the Serenity Isopure is similar to the Isopure 123.

    Table 3 Refractive and Monocular Visual Outcomes of Several Clinical Studies Carried Out on Patients Implanted with the Isopure 1.2.3. Intraocular Lens and the Current Study with the Isopure Serenity Intraocular Lens. This Table Considers Studies with a Minimum of 40 Eyes and 3 Months of Follow-Up

    Visual Acuity

    Focusing now on visual acuity, our results showed that this IOL model provides good far distance visual acuity with functional intermediate vision. Table 2 shows the mean values for the different distances and Figure 3 plots the different cumulative percentages. The CDVA values in our trial exceed that of the real-world data reported by EUREQUO20 based on more than 368,000 cataract operations. Specifically, EUREQUO20 reported that a CDVA of ≥20/40 and ≥20/20 was obtained in 94.3% and 61.3% of the cases, respectively, versus 100% and 98.15%, respectively, with this study. The average values for UDVA and CDVA in our study were 0.02±0.11 logMAR and –0.04±0.05 logMAR, respectively. Compared with previous publications on the Isopure 1.2.3, IOL we can see from Table 3 that the mean values are comparable and about 20/20 (although in our case and for Ang et al8 they were better than 20/20: –0.04±0.05 logMAR and –0.01±0.08 logMAR, respectively). At intermediate vision, our mean DCIVA was slightly worse than that reported by Ang et al8 at 80 cm, and also at 66 cm when compared with these authors and Bova and Vita.4 This may be partially explained by differences between the sample size and follow-up period. For near vision, unfortunately, there were no mean DCNVA values reported that could be compared with our sample. The cumulative percentages of visual acuity at different distances were reported by Bernabeu-Arias et al5 and Ang et al8 both studies with a similar follow-up period (4–6 months). For CDVA, our percentage of eyes ≥20/20 was better than that reported by those authors (98.15% versus 76.57%5 and 84.6%8). At 80 cm our value was comparable to that reported by Bernabeu-Arias et al5 and both were worse (about 77%) than that reported by Ang et al8 (about 95%) for cumulative values ≥20/32. At 66 cm, our percentage was lower than in those two studies, with Ang et al8 showing the best outcomes (about 72%). For near vision, our value was better than that published by Bernabeu-Arias et al5 (about 32% versus 22%, for a DCNVA of ≥20/40). These results correlate with the expected outcomes for good vision at far distance with functional intermediate vision due to the extended range of vision created with the isofocal concept based on a polynomial complex surface design.

    Defocus Curve

    An important parameter in IOLs aiming to give vision at different distances is the defocus curve, which illustrates visual acuity as a function of distance/vergence and compares outcomes in this study with previous reports on the Isopure 123. The Isopure Serenity IOL demonstrated good visual performance across a range of distances. For example, the average binocular defocus curve revealed a visual acuity peak located at 0 D (–0.05±0.06logMAR), while maintaining good vision through intermediate defocus levels and reaching the 0.2 logMAR threshold at about –1.75 D of vergence (see Figure 5). The graph of our outcomes exhibits reducing values in a continuous way, proving that there was gap in vision at intermediate distances (from 100 to 67 cm). This level of performance is of practical benefit to its patients, who should be able to comfortably carry out tasks such as viewing a car dashboard or computer monitor without the need for refractive correction. Figure 5 also includes the outcomes obtained in previous studies3,5,8,9 of the Isopure 1.2.3 IOL. These studies consider samples from 173 to 745 patients and follow-up periods from 39 to 4–63,8 months. The outcomes of the Isopure Serenity IOL model obtained in our study broadly agree with them, and we consider that the two IOL models perform similarly. The best visual acuity reported by all the studies, as expected, is at 0 D of vergence (far vision), this being about 0 logMAR for Bernabeu-Arias et al5 and Mencucci et al9 and better, about –0.05 logMAR, for Ang et al8 and this study. All the studies show a smooth reduction in visual acuity as a function of vergence (closer distances), with no gaps from far to near vision. The depth of focus considering a 0.2 logMAR limit for all studies in the figure was about 1.50 D for Bernabeu-Arias et al5 and Mencucci et al9 and about 1.75 D for Ang et al8 and in our study. The difference, about 0.25 D, is minimal and, therefore, we consider that both IOL models offer the same depth-of-focus when implanted.

    While the follow-up period of 3 months is a limitation, it is sufficient to consider lens performance, which is similar to its predecessor. Contrast sensitivity testing and aberrometry along with patient reported outcome measures are useful outcomes measures, which should be included in future studies.

    Conclusions

    In summary, we conclude that the clinical outcomes of this multicentre study indicate that Isopure Serenity IOL implantation allows accurate refractive outcomes and good far distance and functional intermediate vision. Future clinical studies with larger samples and, when possible, longer follow-ups would be desirable to ratify the present outcomes.

    Acknowledgment

    We thank Filippo Confalonieri, Alessandro Gaeta, Silvia Sonego, Alfonso Strianese, Paolo Vinciguerra and Silvia Zappa for collaborating in this study.

    Funding

    There is no funding to report.

    Disclosure

    Dr Sheraz Daya is a consultant for BVI, Ndek, Rayner, Bausch and Lomb, Tarsus, Oysterpoint; equity holder of Exclens, and owner of Infinite Medical Ventures. Dr Camile Bosc is a consultant for BVI; personal fees and/or non-financial support from BVI and Hoya. Dr Christophe Chassain reports royalties from BVI for designing the PODeye Platform. The authors report no other conflicts of interest in this work.

    References

    1. Karam M, Alkhowaiter N, Alkhabbaz A, et al. Extended depth of focus versus trifocal for intraocular lens implantation: an updated systematic review and meta-analysis. Am J Ophthalmol. 2023;251:52–70. doi:10.1016/j.ajo.2023.01.024

    2. Gutiérrez DF, Briones BS, Díaz DC, Celestino SM. Refractive multifocal intraocular lens with optimised optical quality in a range of focus and method to produce it. Patent EP2941222A1. 2013.

    3. Stodulka P, Slovak M. Visual performance of a polynomial extended depth of focus intraocular lens. Open J Ophthalmol. 2021;11:214–228. doi:10.4236/ojoph.2021.113017

    4. Bova A, Vita S. Clinical and aberrometric evaluation of a new monofocal iol with intermediate vision improvement. J Ophthalmol. 2022;2022:4119698. doi:10.1155/2022/4119698

    5. Bernabeu-Arias G, Beckers S, Rincón-Rosales JL, Tañá-Rivero P, Bilbao-Calabuig R. Visual performance at different distances after implantation of an isofocal optic design intraocular lens. J Refract Surg. 2023;39(3):150–157. doi:10.3928/1081597X-20230124-02

    6. Tomagova N, Elahi S, Vandekerckhove K. Clinical outcomes of a new non-diffractive extended depth-of-focus intraocular lens targeted for mini-monovision. Clin Ophthalmol. 2023;17:981–990. doi:10.2147/OPTH.S405267

    7. Lesieur G, Dupeyre P. A comparative evaluation of three extended depth of focus intraocular lenses. Eur J Ophthalmol. 2023;33(6):2106–2113. doi:10.1177/11206721231154818

    8. Ang RET, Stodulka P, Poyales F. Prospective randomized single-masked study of bilateral isofocal optic-design or monofocal intraocular lenses. Clin Ophthalmol. 2023;17:2231–2242. doi:10.2147/OPTH.S425352

    9. Mencucci R, Morelli A, Cennamo M, Roszkowska AM, Favuzza E. Enhanced monofocal intraocular lenses: a retrospective, comparative study between three different models. J Clin Med. 2023;12(10):3588. doi:10.3390/jcm12103588

    10. Pérez-Sanz L, Charbel C, Poyales F, Garzón N. Influence of isofocal intraocular lenses on objective refraction based on autorefraction and aberrometry. Graefes Arch Clin Exp Ophthalmol. 2023;261(10):2863–2872. doi:10.1007/s00417-023-06102-4

    11. Danzinger V, Schartmüller D, Schwarzenbacher L, et al. Clinical prospective intra-individual comparison after mix-and-match implantation of a monofocal EDOF and a diffractive trifocal IOL. Eye. 2024;38(2):321–327. doi:10.1038/s41433-023-02682-x

    12. Danzinger V, Schartmüller D, Lisy M, et al. Fellow-eye comparison of monocular visual outcomes following monofocal Extended Depth-of-Focus (EDOF) and trifocal EDOF intraocular lens implantation. Am J Ophthalmol. 2024;267:76–83. doi:10.1016/j.ajo.2024.05.029

    13. Fernández-Núñez S, Pérez-Sanz L, Gómez-Pedrero JA, García-Montero M, Albarrán-Diego C, Garzón N. Optical quality in vitro and in vivo of an extended depth-of-focus intraocular lens with isofocal design. Graefes Arch Clin Exp Ophthalmol. 2024;262(12):3905–3913. doi:10.1007/s00417-024-06590-y

    14. Assaf AH, Samy H, Fawky N, Kamel MA. Evaluation of visual outcomes, postoperative angle alpha, and angle kappa after implantation of isofocal intraocular lenses. Clin Ophthalmol. 2024;18:2879–2890. doi:10.2147/OPTH.S478471

    15. Baoud Ould Haddi I, Flores Cervantes D, Dorronzoro Ramírez E, Blázquez Sánchez V, Bonnin Arias C. Comparison of visual function with three intraocular lenses under different illumination conditions. J Fr Ophtalmol. 2025;48(3):104429. doi:10.1016/j.jfo.2025.104429

    16. Abulafia A, Koch DD, Holladay JT, Wang L, Hill W. Pursuing perfection in intraocular lens calculations: IV. Rethinking astigmatism analysis for intraocular lens-based surgery: suggested terminology, analysis, and standards for outcome reports. J Cataract Refract Surg. 2018;44(10):1169–1174. doi:10.1016/j.jcrs.2018.07.027

    17. Reinstein DZ, Archer TJ, Srinivasan S, et al. Standard for reporting refractive outcomes of intraocular lens-based refractive surgery. J Refract Surg. 2017;33(4):218–222. doi:10.3928/1081597X-20170302-01

    18. Lundström M, Dickman M, Henry Y, et al. Risk factors for refractive error after cataract surgery: analysis of 282,811 cataract extractions reported to the European registry of quality outcomes for cataract and refractive surgery. J Cataract Refract Surg. 2018;44(4):447–452. doi:10.1016/j.jcrs.2018.01.031

    19. Pérez-Sanz L, Vega F, Azor-Morón JA, Cuellar F, Millán MS, Garzón N. Tolerance to residual astigmatism of an isofocal intraocular lens. Graefes Arch Clin Exp Ophthalmol. 2024;262(4):1169–1180. doi:10.1007/s00417-023-06305-9

    20. Lundström M, Barry P, Henry Y, Rosen P, Stenevi U. Visual outcome of cataract surgery; study from the European registry of quality outcomes for cataract and refractive surgery. J Cataract Refract Surg. 2013;39(5):673–679. doi:10.1016/j.jcrs.2012.11.026

    Continue Reading

  • Kojima Productions to celebrate 10th anniversary this month with “glimpse into future projects”

    Kojima Productions to celebrate 10th anniversary this month with “glimpse into future projects”


    Kojima Productions has announced a 10th anniversary celebration to be held in Japan, which promises guest appearances and “a glimpse into future projects”.


    The studio unveiled the event today, on the 10th anniversary of Metal Gear Solid 5: The Phantom Pain, which doesn’t seem coincidental.


    The Kojima Productions Beyond The Strand event will take place on 23rd September at a cinema in Tokyo, but it doesn’t appear to be screened elsewhere. Hideo Kojima himself will host the event.

    12 Things You NEED To Do First In Death Stranding 2 – BEGINNERS TIPSWatch on YouTube


    Still, keep that date in your diaries if you’re interested to know what’s coming next from the studio.


    Perhaps we’ll see something on OD, Kojima’s Xbox horror game first announced back in 2023? In a recent interview, Kojima stated OD was “something totally different” and people will either “love it or hate it”.


    Or perhaps we’ll see a first look at Physint, Kojima’s return to the action-espionage genre he popularised with the Metal Gear Solid games. Then again, he recently stated it’s early enough in development he’s still working on it by himself.


    Just don’t expect Death Stranding 3 – Kojima confirmed he has a concept for a sequel, but won’t be making it himself.


    If you’re in Japan, you can find details of the anniversary event on the Kojima Productions website.

    This is a news-in-brief story. This is part of our vision to bring you all the big news as part of a daily live report.

    Continue Reading

  • Silver Fox Exploits Signed Drivers to Deploy ValleyRAT Backdoor

    Silver Fox Exploits Signed Drivers to Deploy ValleyRAT Backdoor

    A newly detected cyber campaign is exploiting trusted but vulnerable Windows drivers to bypass security protections and install a remote access tool.

    The operation, attributed by Check Point Research (CPR) to the Silver Fox APT group, highlights the risks of attackers exploiting Microsoft-signed drivers that were once considered safe.

    Abusing Microsoft-Signed Drivers

    At the center of the attack is the WatchDog Antimalware driver (amsdk.sys, version 1.0.600).

    Although signed by Microsoft and not previously listed as vulnerable, the driver was abused to terminate processes linked to antivirus and EDR tools, clearing the way for the deployment of ValleyRAT – a modular backdoor capable of surveillance, command execution and data exfiltration.

    Silver Fox also relied on an older Zemana-based driver (ZAM.exe) to maintain compatibility across systems ranging from Windows 7 to Windows 11.

    Both drivers allowed arbitrary process termination, enabling the attackers to disable even protected processes.

    Read more on Windows driver exploitation tactics: Vulnerability in Windows Driver Leads to System Crashes

    Researchers found that the group packed all elements into self-contained loader binaries.

    Each sample included:

    The campaign quickly evolved, producing variants that used new drivers or altered versions of patched drivers to avoid detection.

    Evasion and Attribution

    One technique involved modifying a patched WatchDog driver (wamsdk.sys, version 1.1.100) by changing a single byte in its timestamp field. Because Microsoft’s digital signature does not cover this field, the driver signature remained valid yet appeared as a new file with a different hash.

    Infrastructure used in the attacks was traced to servers in China, while malware configurations specifically targeted security products popular in East Asia. These details, combined with the ValleyRAT payload, led to attribution to the Silver Fox APT.

    Although WatchDog released an update addressing local privilege escalation flaws, arbitrary process termination remains possible leaving systems vulnerable.

    The CPR research stressed that signature and hash checks alone are insufficient. Security teams are advised to apply Microsoft’s latest driver blocklist, use YARA detection rules and implement behavior-based monitoring to catch abnormal driver activity.

    “Our research reinforces the need for ongoing efforts of security vendors and users to stay vigilant against the emerging abuse of legitimate drivers,” CPR wrote.

    “Proactive identification, reporting and patching of these vulnerabilities are critical to strengthening Windows systems against evolving threats leveraging Bring Your Own Vulnerable Driver (BYOVD) techniques.”

    Continue Reading

  • The Eversolo T8 streaming transport wants to deliver “high-end audio experience for music lovers and audiophiles alike”

    The Eversolo T8 streaming transport wants to deliver “high-end audio experience for music lovers and audiophiles alike”

    It was teased at High End Munich earlier this year, but we now have official details and prices for the Eversolo T8. This is Eversolo’s first streaming transport, i.e. a product with all the latest network streaming software and features but without a DAC built in; so you will need to plug it into an external DAC or into the digital inputs of your amplifier.

    It’s a neat way to add modern streaming powers to a hi-fi system that already has a great DAC. It could also prove to be a smart route for the brand, considering how we have heaped praise on Eversolo’s excellent streaming software and its capability as a digital source in the DMP-A6 and DMP-A10 streamers that we have tested.

    The T8 aims to deliver “clean, precise digital audio” and features carefully isolated digital outputs, an ultra-high precision clock, and all the bells and whistles that come with Eversolo’s proprietary software ecosystem.

    (Image credit: Eversolo)

    The Eversolo T8 features a 6-inch touchscreen display that lets you select the numerous music apps and services available, control playback, adjust settings and more. This display screen dominates the front of a sleek, aluminium chassis that boasts shielding from its internal circuitry as well as from outside electromagnetic interference.

    Continue Reading

  • How ageing changes our genes — huge epigenetic atlas gives clearest picture yet

    How ageing changes our genes — huge epigenetic atlas gives clearest picture yet

    A huge analysis of DNA methylation in human tissue has revealed new anti-ageing targets.Credit: Lawrence Lawry/SPL

    The visible effects of ageing on our body are in part linked to invisible changes in gene activity. The epigenetic process of DNA methylation — the addition or removal of tags called methyl groups — becomes less precise as we age. The result is changes to gene expression that are linked to reduced organ function and increased susceptibility to disease as people age.

    Now, a meta-analysis of epigenetic changes in 17 types of human tissue throughout the entire adult lifespan provides the most comprehensive picture to date of how ageing modifies our genes.

    The study assessed DNA methylation patterns in human tissue samples and revealed that some tissues seem to age faster than others. The retina and stomach, for example, accumulate more ageing-related DNA methylation changes than do the cervix or skin. The analysis also found universal epigenetic markers of ageing across different organs. This ‘epigenetic atlas’ might help researchers to study the link between DNA methylation and ageing and could aid the identification of molecular targets for anti-ageing treatments.

    “I think this is a great resource” to understand ageing, says Joao Pedro Magalhaes, a molecular biologist at the University of Birmingham, UK. “This meta-analysis of methylation data across organs is, to my knowledge, the largest such resource assembled to date. I am sure that it will be valuable to researchers.”

    The work is reported on the preprint server Research Square1 and has not yet been peer reviewed.

    Epigenetic atlas of ageing

    Researchers can already analyse DNA methylation patterns in people’s genomes to create ageing clocks — tools that measure biological age. However, there are unresolved fundamental questions about whether these signatures of ageing are shared across tissue types.

    To elucidate how methylation relates to ageing, Nir Eynon at Monash University in Melbourne, Australia, and his colleagues conducted a meta-analysis of more than 15,000 samples from 17 human tissues taken from adults of different ages. They mapped out methylation changes across 900,000 potential sites in the DNA, then created an open-access atlas. “We had examples from people from 18 years old till 100 or so,” says Eynon, so we can look at the epigenetic markers and how they change across the human lifespan.

    Overall, the researchers found that the mean amount of methylation varies greatly between tissues, ranging from 35% in the cervix, through to 48% in skin, 51% in muscle, 53% in the heart, 57% in the stomach and up to 63% in the retina.

    Study co-author Macsue Jacques, also at Monash University, says almost all tissues have increased DNA methylation as they age. The exceptions are skeletal muscle and lung, “which has more of a loss of methylation with age”. Their analysis also found that different organs have distinct ageing patterns of DNA methylation. “Each tissue has a different shift that happens,” Jacques says.

    Ageing methylation targets

    As well as examining differences between tissues, the researchers screened individual gene sites throughout each tissue genome. “We wanted to find a common ageing mechanism that goes across all the tissue types,” says Jacques.

    They found several genes that had methylation changes were strong biological markers of ageing across several tissues. These included the developmental regulators HDAC4 and HOX, which are related to senescence and age-related decline, and MEST, which has been associated with diabetes and obesity, two known accelerators of ageing2.

    The researchers identified high methylation of the protocadherin gamma (PCDHG) gene family as a driver of the ageing process in multiple different organs. Other studies have shown that hypermethylation in the PCDHG gene family is linked to reduced white matter in the brain, a marker of accelerated cognitive decline3.

    Continue Reading

  • iPhone 17 Cases Leak Again, Official Clear Case May Be Only Semi-Transparent – PCMag

    1. iPhone 17 Cases Leak Again, Official Clear Case May Be Only Semi-Transparent  PCMag
    2. iPhone 17 Pro: The New “Clear Case” Design Unveiled  MajinBu Official
    3. More iPhone 17 series cases leak ahead of September 9 event – GSMArena.com news  GSMArena.com
    4. iPhone 17 launch on September 9: Apple may bring this unique accessory for 2025 iPhone lineup  The Times of India
    5. iPhone 17 series design leaked ahead of September 9 launch  NewsBytes

    Continue Reading

  • Sony is hosting a State of Play showcase for 007 First Light on September 3

    Sony is hosting a State of Play showcase for 007 First Light on September 3

    Sony has lined up its next PlayStation State of Play showcase, and this one is all about a single game. It will focus on , the long-awaited James Bond adventure from Hitman studio IO Interactive. It starts at 2PM ET on September 3 and you can watch it on the PlayStation and channels (there’ll also be a version of the video with English subtitles on ). You can also just hit the play button on the YouTube video above when the time is right.

    The showcase will run for over 30 minutes and it will feature a deep dive into gameplay, including a full playthrough of a young Bond’s first mission. Over on the , IOI said to expect “everything from high-speed car chases to on-foot stealth sequences and shootouts.” Following that, IOI will offer up more details on 007 First Light gameplay. Perhaps we’ll also get a release date or narrower window for the action-adventure game, which is slated to hit Nintendo Switch 2, PlayStation 5, Xbox Series X/S and PC in 2026.

    In the meantime, you can get a taste of just why IOI was able to land this gig by checking out Hitman World of Assassination, a bundle of all three of the main Hitman games from the last decade. , and you can play through the first location for free. It’s also available on PC and consoles.

    Continue Reading

  • iphone 17 news: Battle of the iPhones: 17, Air, and Pro rumors spark wild buzz among Apple fans

    iphone 17 news: Battle of the iPhones: 17, Air, and Pro rumors spark wild buzz among Apple fans

    As Apple’s flagship event is almost around the corner, excitement is building up, and so are the rumors. iPhone enthusiasts are beyond ecstatic as the official release date of the iPhone 17 lineup gets closer. This new lineup will reportedly have four phones and the biggest change is the addition of an ultra-thin model that is said to be called the iPhone 17 Air.

    The new iPhones are going to be one of Apple’s most talked-about launches in years. They have better cameras, charge faster, are thinner, and have more powerful chips. This is everything we know so far about the iPhone 17, iPhone 17 Air, and iPhone 17 Pro.


    Here are all the new rumored features, as per a report by Tom’s Guide.

    What’s different about the iPhone 17?

    The standard iPhone 17 is likely to make the biggest jump forward in years. According to reports, Apple is adding a 120 Hz display to its devices. This feature was only available on Pro models before, and it makes scrolling and gaming smoother. The screen will also get a little bigger, going from 6.27 inches to 6.27 inches with thinner bezels.

    ALSO READ: GMA’s Labor Day deals and steals: Shop huge discounts with free shipping today


    There will also be changes to the design. The iPhone 17 will have a frame made of both aluminum and glass, but titanium will only be available on the Pro versions. Renders show a glass area around the Apple logo and MagSafe charger for a cleaner, more modern look, as per a report by Tom’s Guide.The front camera goes from 12MP to 24MP with six elements, which makes selfies look better. Charging will also get better. Wired speeds are said to go up to 35W, and wireless charging could reach 50W with Qi 2.2 support, as per a report by Tom’s Guide.One problem? Some reports say that the iPhone 17 may keep the same chip instead of upgrading to the A19 processor, which would leave some power users wanting more.

    ALSO READ: Lorde’s dating history: here’s a closer look at the confirmed and rumored romances of New Zealand electropop sensation

    How thin will the iPhone 17 Air be?

    Apple is changing things up by replacing the iPhone 16 Plus with the iPhone 17 Air, which is a very thin model that is expected to be only 5.5mm thick at its thinnest point. Even though it is thin, it will have a 6.6-inch screen, which is bigger than the iPhone 17’s screen, as per a report by Tom’s Guide.

    It is expected to have the same 24MP selfie camera, 120Hz display, and faster charging as its sibling. But the Air is said to be getting Apple’s C1 cellular modem and a smaller 2,900 mAh battery to save space. That could be a problem for heavy users, as some reports say it might not last a full day on one charge, as per a report by Tom’s Guide.

    Rumor has it that Apple is making a smart battery case to go with this limitation. The A19 chip will also power the Air, but its graphics performance will be a little less good than that of the Pro models.

    The camera setup is the biggest compromise. The iPhone 17 Air may only have one 48MP camera lens, unlike the standard iPhone with two lenses or the Pros with three lenses. This means that the telephoto and ultrawide options will not be available, as per a report by Tom’s Guide.

    What are the differences between the iPhone 17 Pro and Pro Max?

    The Pro lineup is likely to have the biggest improvements. The new 3nm A19 Pro chipset will power both the iPhone 17 Pro and Pro Max. This will make them better at computing, graphics, and AI tasks. They’ll also get 12GB of RAM, which will help improve the Apple Intelligence features.

    Apple is said to be adding vapor chamber cooling to keep things cool and make them run better when they are being used a lot. There are rumors that the telephoto lens will go from 12MP to 48MP with up to 8x zoom. This would mean that all three rear lenses would have 48MP sensors.

    Other changes include support for reverse wireless charging, faster charging speeds, and the same improvements to the 24MP front camera that are available on all models. Apple might switch from titanium to aluminum for the frame, which is the opposite of what has been happening in the past few years.

    ALSO READ: How serious is Rudy Giuliani’s injuries, is he out of danger? Here’s what reports say

    FAQs

    When will the iPhone 17 series come out?
    Apple is likely to show off the iPhone 17 lineup on September 9.

    What is the iPhone 17 Air’s biggest new feature?
    It stands out from the other models because of its very thin design and single 48MP camera.

    Add ET Logo as a Reliable and Trusted News Source

    Continue Reading

  • Apple adds more iPhone models to vintage list ahead of September 9 iPhone 17 launch – The Times of India

    1. Apple adds more iPhone models to vintage list ahead of September 9 iPhone 17 launch  The Times of India
    2. Apple Says 11-Inch MacBook Air and Two Other Macs Are Now Obsolete  MacRumors
    3. Apple declares these iPhone models vintage days before iPhone 17 launch  India Today
    4. Apple now considers these MacBooks and iPhone as vintage or obsolete products  Moneycontrol
    5. Apple updates its vintage iPhones list ahead of iPhone 17 series launch: Here’s all you need to know  digit.in

    Continue Reading

  • Mind Labyrinth VR Dreams launches on PlayStation®VR2

    September 1st, 2025

    Mind Labyrinth VR Dreams launches on PlayStation®VR2

    A milestone in meditative VR, an internationally acclaimed classic now available on PSVR2 and PS5 PRO

    Celebrated as one of the most innovative titles in the field of digital meditation, Mind Labyrinth VR Dreams is now available in a brand-new edition for PlayStation®VR2, fully compatible with PlayStation®5 and optimized for PlayStation®5 PRO.

    Already considered a classic in its genre and nominated at the prestigious VR Fitness Awards as “Best VR Meditation App of the Year”, the game now returns on PSVR2 with enhanced technical performance, bringing its symbolic worlds and emotional atmospheres to a new level of immersion.

    Click here:

    Mind Labyrinth VR Dreams PSVR2 Official Trailer

    With its evocative environments and emotional landscapes, Mind Labyrinth VR Dreams guides players through a unique inner journey of calm, awareness, and emotional regeneration. Each scenario is carefully designed to evoke a specific emotional resonance — from light to shadow, from warmth to freshness — accompanied by a remarkable soundtrack featuring Oscar®-winning composers and internationally acclaimed artists.

    The title also introduces dedicated meditation refuges enriched with Theta and Delta frequencies, scientifically known to promote deep relaxation and introspection. Developed with the support of international research centers, Mind Labyrinth VR Dreams has already been used in clinical settings to assist emotional recovery and guided visualization.

    “With Mind Labyrinth VR Dreams we wanted to create an interactive space to slow down, explore, and reconnect with yourself. The PSVR2 port allows players to experience this journey with even greater visual quality and immersive power,” says the MY WORLD team.

    Mind Labyrinth VR Dreams is available today on PlayStation®Store for PSVR2, fully compatible with PlayStation®5 and PS5 PRO.

    Press Contact:


    MY WORLD srls


    Cinzia

    cinzia@myworldmedia.eu

    My World Website

    https://www.myworldmedia.eu


    About MY WORLD


    MY WORLD is an independent publisher and developer focused on high-quality interactive experiences for well-being, creativity, and emotional exploration. With a catalog that includes acclaimed titles such as Yoga Master, Oniriam and Brain Beats, MY WORLD aims to combine innovation, art, and science to create meaningful digital worlds for players around the globe.


     

    Continue Reading