Category: 3. Business

LOS ANGELES – Tea, the women-only dating safety app that surged to the top of the App Store this month, is now facing growing backlash—not only for a massive data breach, but for how the exposed information is being misused online.

In the days following the leak of 72,000 images, internet trolls reportedly created a now-deleted website where users could view and rate women whose selfies were among the stolen files. A separate map, still circulating online, allegedly plots locations tied to those same leaked photos—raising new fears about stalking and real-world targeting.

Why some say this wasn’t a hack

The backstory:

Tea confirmed in a statement that an old database containing approximately 72,000 images—including 13,000 selfies and photo IDs—was accessed without authorization. The company blamed the breach on a “legacy data storage system” that had not been properly secured.

But multiple reports argue this wasn’t a traditional hack. According to 404 Media, which first broke the story, the breach was discovered by users on 4chan who accessed the files through a publicly available URL. The site reported, “a URL the 4chan user posted included a voluminous list of specific attachments associated with the Tea app… that page was locked down, and now returns a ‘Permission denied’ error.”

In a TikTok video posted July 26, software engineer and content creator Frank Niu echoed that sentiment, saying the situation was less a hack and more “poor programming.” 

“They used no security measures whatsoever and anyone could have found this information pretty easily,” Niu said. 

Tea said the archived data was kept online “in accordance with law enforcement requirements related to cyber-bullying investigations,” but acknowledged it should have been moved to “a new fortified system.”

What we know:

Tea confirmed:

• The exposed images included selfies, photo IDs, and app content from posts and messages.
• Only users who signed up before February 2024 were affected.
• No email addresses or phone numbers were exposed, per the company.

Tea says it is working with third-party cybersecurity experts and has implemented new security measures.

What we don’t know:

It’s still unclear:

• Whether impacted users will be notified directly.
• If Tea will offer assistance with identity protection or credit freezes.
• Whether the leaked data is still being redistributed or used elsewhere.

Tea has advised concerned users to reach out to support@teaforwomen.com.

Weaponizing the leak: The site, the map, and the backlash

What they’re saying:

Shortly after the breach, a website appeared at spill.info.gf, where users could allegedly browse leaked Tea user selfies and rate them. The domain has since gone offline, but not before drawing backlash across social media.

On X, creator Brian Atlas posted: “There’s now a site where you can search every girl on the Tea app and rate them,” linking to the page.

Separately, The New York Times reported that a Google Map had surfaced online showing coordinates extracted from the leaked photos. While the map did not contain names, the Times noted it could not verify whether the locations were accurate or linked to specific users.

Meanwhile, a columnist for The Times of London described Tea as a “man-shaming site,” writing: “This is simply vigilante justice, entirely reliant on the scruples of anonymous women. With Tea on the scene, what man would ever dare date a woman again?”

Aaron Minc, an attorney who specializes in online defamation and harassment, told Reuters, “Over the last couple of weeks, we’ve gotten hundreds of calls on it. It’s blown up. People are upset. They’re getting named. They’re getting shamed.”

Big picture view:

Tea’s mission was to protect women from unsafe dates by letting them share anonymous reviews of men they’ve encountered. But the very verification process designed to ensure user safety—uploading selfies and photo IDs—has now made some users targets.

According to Tea’s privacy policy, verification photos are “securely processed and stored only temporarily.” However, the company said the breached dataset included older images that were archived to comply with law enforcement guidance on cyberbullying.

While Tea insists “there is no evidence to suggest that photos can be linked to specific users within the app,” the real-world risk looms large. The leak has sparked concerns about identity theft, doxxing, deepfakes, and harassment.

Some critics say Tea’s rapid growth—4 million users and a 525% spike in downloads in one week, according to Sensor Tower—may have outpaced its infrastructure.

What’s next:

Tea says the vulnerability has been fixed, and that new security protocols are in place. But the company has not said whether it will take further steps to support the women affected by the breach.

Users who suspect their data was compromised are being urged to:

• Contact Tea support directly
• Consider replacing photo IDs
• Freeze their credit and monitor for identity theft

The full scope of the breach, and how widely the data has spread, is still being investigated.

Social Media

The FDA has accepted the biologics license application (BLA) and granted priority review to tabelecleucel (tab-cel; Ebvallo) monotherapy in adult and pediatric patients 2 years of age or older with Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease (PTLD) who received at least 1 prior line of therapy, according to a press release from Pierre Fabre Pharmaceuticals (PFP).¹

The FDA has set a Prescription Drug User Fee Act target action date of January 10, 2026. If approved, it would be the first approved therapy in the US for EBV-positive PTLD.

Previously, the FDA accepted the submitted BLA for tab-cel in the proposed indication in July 2024; in January 2025, the FDA then issued a complete response letter to the developer due to observations as part of a pre-license inspection of a third-party manufacturing facility for tab-cel; in May 2025, the clinical hold was lifted after the agency reviewed additional data on the finished drug product; and in July 2025, the developers resubmitted the BLA for tab-cel in the proposed indication.^2-5

The phase 3 ALLELE trial (NCT03394365) evaluated the efficacy and safety of tab-cel in this population of patients with EBV-positive PTLD who previously received solid organ transplant or hematopoietic cell transplantation; results from the trial supported the FDA’s decision. Updated results were shared at the 51st Annual European Society for Blood and Marrow Transplantation Meeting.

“Patients diagnosed with relapsed/refractory EBV-positive PTLD have no approved FDA treatment options, and following failure of initial therapy, their survival is unfortunately measured in only weeks to months. Today’s BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in the US,” stated Adriana Herrera, chief executive officer of PFP, in the press release.¹ “We are now completely focused on preparing for potential FDA approval of this innovative new treatment option.”

The overall response rate (ORR) with tabelecleucel in all patients (n = 75) was 50.7% (95% CI, 38.9%-62.4%), with a complete response (CR) rate of 28.0% and a partial response (PR) rate of 22.7%. Patients who underwent hematopoietic stem cell transplant (HSCT; n = 26) demonstrated an ORR of 50.0%, with a CR rate of 30.8% and a PR rate of 19.2%; those who underwent solid organ transplant (n = 49) had an ORR of 51.0%, with a CR rate of 24.5% and a PR rate of 26.5%.

The estimated median duration of response was 23.0 months (95% CI, 12.1-not evaluable [NE]) for all responders, 19.0 months (95% CI, 1.5-NE) for responders who underwent HSCT (n = 13), and NE (95% CI, 6.8-NE) for responders who underwent solid organ transplant (n = 25). The median time to response and time to best response, respectively, was 1.1 months (95% CI, 0.6-9.0) and 1.6 months (95% CI, 0.6-9.0) in all patients, 1.0 months (95% CI, 0.6-9.0 and 1.0 months (95% CI, 0.6-9.0) in those who underwent HSCT, and 2.0 months (95% CI, 0.7-4.7) and 2.1 months (95% CI, 0.7-7.3) in those who underwent solid organ transplant.

The median overall survival (OS) was 18.4 months (95% CI, 5.7-NE) in all patients, NE (95% CI, 18.6 months-NE) in responders, and 3.7 months (95% CI, 1.8-11.0) in nonresponders; the 12-month OS rates were 55.7%, 78.7%, and 28.2%, respectively. Among responders, the median PFS was 23.9 months, and the 12-month PFS rate was 71.9%.

The trial enrolled patients with biopsy-proven EBV-positive PTLD who were relapsed/refractory to rituximab (Rituxan) following prior allogeneic HSCT or rituximab with or without chemotherapy after solid organ transplant; they were required to have an ECOG performance status of 3 or lower.

Tab-cel was administered intravenously at 2.0 x 10⁶ cells/kg on days 1, 8, and 15 of each 5-week treatment cycle; additional tab-cel was given until patients achieved best response, and those who did not respond were permitted to switch to tab-cel using a T-cell line with different HLA restrictions.

The trial’s primary end point was ORR. Key secondary end points were time to response, time to best response, OS, and PFS.

Regarding safety, treatment-emergent serious adverse effects (AEs) occurred in 62.7% of all patients; 8.0% were related to treatment. All fatal treatment-emergent serious AEs were not related to treatment.

Instances of tumor flare reactions, infusion-related reactions, cytokine release syndrome, bone marrow rejection, and immune effector cell-associated neurotoxicity syndrome were not reported by any patients.

References

1. Pierre Fabre Pharmaceuticals Inc. announces FDA acceptance and priority review of the biologics license application (BLA) for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). News release. Pierre Fabre Pharmaceuticals. July 25, 2025. Accessed July 28, 2025. https://tinyurl.com/5hfdh7cn
2. Atara Biotherapeutics announces U.S. FDA acceptance and priority review of the Biologics License Application for tabelecleucel (tab-cel®) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. News Release. Published July 17, 2024. Accessed July 28, 2025. https://tinyurl.com/yc4dx6yk
3. Atara Biotherapeutics provides regulatory and business update on EBVALLO™ (tabelecleucel). News release. Atara Biotherapeutics. January 16, 2025. Accessed July 28, 2025. https://tinyurl.com/3p9jrrtj
4. Atara Biotherapeutics provides regulatory updates on EBVALLO (tabelecleucel). News release. Atara Biotherapeutics Inc. May 5, 2025. Accessed July 28, 2025. https://tinyurl.com/3cekvud5
5. Atara Biotherapeutics provides regulatory and business updates on tabelecleucel (tab-cel). News release. Atara Biotherapeutics Inc. July 14, 2025. Accessed July 28, 2025. https://tinyurl.com/25pxk95y
6. Dierick D, Ghobadi A, Baiocchi R, et al. Updated results: multicenter open-label ph 3 study of tabelecleucel for SOT or HCT recipients with EBV+ PTLD after failure of rituximab or rituximab + chemotherapy. Presented at: EBMT 51st Annual Meeting; March 30-April 2, 2025. Florence, Italy. Abstract OS17-03.

(Bloomberg) — Wall Street traders left stocks at all-time highs while the dollar climbed the most since May, with a tariff deal between President Donald Trump and the European Union bolstering hopes for an extension of a China trade truce. Treasuries edged lower.

The start of a week that will set the tone for the rest of the year in markets saw a dollar gauge up nearly 1%. The euro slid the most in over two months. The S&P 500 briefly topped 6,400 to close little changed. Treasuries barely budged amid mixed results from US debt sales. Oil rose as Trump said he’d shorten his timeline for Russia to reach a truce with Ukraine.

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In the run-up to the Aug. 1 US tariff deadline, traders will go through a raft of key data from jobs to inflation and economic activity. The big event comes Wednesday, when the Federal Reserve is expected to keep rates unchanged. Then there’s a string of big-tech earnings, with four megacaps worth a combined $11.3 trillion reporting results.

“This is about as busy as a week can get in the markets,” said Chris Larkin at E*Trade from Morgan Stanley. “This week could make or break that momentum in the near term.”

US and Chinese officials finished the first of two days of talks aimed at extending their tariff truce beyond a mid-August deadline and hashing out ways to maintain trade ties while safeguarding economic security. Canada Prime Minister Mark Carney said his government is still deep in trade talks with the Trump administration.

The Treasury jacked up its estimate for federal borrowing for the current quarter to $1 trillion, mainly due to distortions from the debt limit. On Wednesday, the department will announce its plans for note and bond sales over coming months — which dealers widely see as staying unchanged.

Speaking in Scotland on Sunday to announce the EU deal, Trump gave a brief update on Washington’s relations with Beijing. “We’re very close to a deal with China. We really sort of made a deal with China, but we’ll see how that goes,” he said without elaborating.

“It is possible that as more trade deals are announced, the level of uncertainty that has hovered over business and the economy will ease,” said Brent Schutte at Northwestern Mutual Wealth Management Co. “Additionally, the impact of final trade deals could be less than originally forecast after the April 2 announcement of reciprocal tariffs.”

To Thierry Wizman at Macquarie Group, while the dollar’s strength today may reflect the perception that the new EU deal is lopsided in favor of the US, it may also reflect a feeling that America is reengaging with its major allies.

“Whether we agree or not with the use of tariffs and the deals announced, we are getting the big ones out of the way which will allow American businesses to adjust and plan, for better or worse,” said Peter Boockvar at the Boock Report. “And we can now focus on how this all plays out.”

Fed Chair Jerome Powell and his colleagues will step into the central bank’s board room for a two-day meeting starting Tuesday to deliberate on rates at a time of immense political pressure, evolving trade policy, and economic cross-currents.

In a rare occurrence, policymakers will convene in the same week that the government issues reports on gross domestic product, employment and the Fed’s preferred price metrics. Forecasters anticipate the heavy dose of data will show economic activity rebounded in the second quarter.

While the stock market is moving sideways after a solid run, “if we get no surprises in earnings and some dovish comments by the Fed, it’s likely we’ll see yet more new highs by the end of the week,” said Louis Navellier, chief investment officer at Navellier & Associates.

“We do not expect the Federal Reserve to cut interest rates on Wednesday, but it’s possible that they make a stronger signal that cuts are on the horizon in the fall, especially as the inflation data continues to stay muted even in this tariff environment,” said Rick Gardner at RGA Investments.

Gardner also says that while stock market valuations are high, that in and of itself is not a reason why valuations can’t expand even further from here.

In fact, this earnings season is off to a solid start, and all eyes will be on results from Microsoft Corp. and Meta Platforms Inc. on Wednesday, and Apple Inc. and Amazon.com Inc. on Thursday.

So far, Corporate America appears to be taking tariffs in stride. With about a third of S&P 500 firms having reported, roughly 82% have beaten profit forecasts, on track for the best quarter in about four years, data compiled by Bloomberg Intelligence show.

Progress in trade negotiations will take the S&P 500 to a third consecutive year of 20% gains, according to Oppenheimer Asset Management’s John Stoltzfus, a feat unseen since the late 1990s. He raised his year-end target for the US benchmark to 7,100.

Some market forecasters including Morgan Stanley’s Michael Wilson have turned more optimistic about the S&P 500 as they expect earnings to remain upbeat.

The technical evidence suggests a broadening of participation in equities off the April low, according to Craig Johnson at Piper Sandler. 

“Despite a slight easing in momentum as investors await earnings, the combination of several major indices at all-time highs and improving market breadth continues to draw investors off the sidelines, offering opportunities to buy the dip,” he said.

At RBC Capital Markets, Lori Calvasina says it would be premature to write off the impact of tariffs on inflation and corporate earnings.

“It also poses a risk to the path of stock prices if company outlooks for 2026 don’t end up being as rosy as investors have been anticipating,” she noted.

The S&P 500 is trading around 22.5 times projected earnings, compared to a 10-year average of 18.6. That’s sparked concerns that there may be little room for error.

The stock market’s stunning rebound and resilience have again emboldened equity investors, who have developed muscle memory around ‘buying the dip’,” according to Lisa Shalett at Morgan Stanley Wealth Management.

“With volatility having decoupled from stress indicators, passive indexes have ground to new highs, while the most speculative corners of the market have begun to lead,” she said. “Complacency is elevated, and valuations are rich. In this environment, we want to be stock-pickers.”

To Mark Hackett at Nationwide, this may be the most compelling intersection of technical momentum and fundamental strength we’ve seen in a long time. 

“The S&P hasn’t had a 1% move in over a month and yet bears have capitulated,” he said. “No one’s willing to short this market, and even typically skeptical investors are getting pulled in. While it’s not a blow-off top yet, the odds of that happening are rising.”

If sentiment keeps shifting and dip buyers remain aggressive, we could see a classic melt-up – and any near-term weakness over the next several weeks is likely to be bought aggressively, he said.

“However, for now, bears are hibernating through the summer,” Hackett concluded.

“We would lean toward being more bullish than bearish on US stocks through year-end, but not outside of a balanced portfolio based on risk,” said Anthony Saglimbene at Ameriprise. “However, that view is contingent on positive corporate profitability and economic growth this year, avoiding worst-case tariff scenarios, and investors remaining willing to ‘buy the dip’.”

Markets have found reassurance in several developments, according to Invesco Global Market Strategy Office.

“For one, the worst fears that manifested around trade in early April haven’t materialized, and key trade agreements are being signed,” the strategists said. “Tariff rates remain vastly elevated compared to last year, but they appear manageable. In our view, it’s likely that the cost can be shared between businesses and consumers without a meaningful impact on growth or inflation.”

Invesco strategists also noted that what should really matter for stocks in the medium and long-term is earnings.

“After a strong market rally, investors should prepare for renewed volatility in the near term,” said Mark Haefele at UBS Global Wealth Management. “Potential market dips could offer an opportunity for investors to build long-term exposure to stocks.”

Corporate Highlights:

• Samsung Electronics Co. will produce AI semiconductors for Tesla Inc. in a new $16.5 billion pact that marks a win for its underperforming foundry division.
• Texas Instruments Inc. was upgraded to outperform at Wolfe Research, which said the chipmaker is “near the end” of a spending cycle.
• Cisco Systems Inc. was downgraded to inline at Evercore, which mentioned valuation following recent gains.
• Nike Inc. was raised to overweight at JPMorgan Chase & Co., which cited the earnings impact of the sportswear maker’s five-pronged multi-year recovery plan.
• Albertsons Cos. demanded that Kroger Co. provide details on personal conduct that led the company to replace its chief executive officer, who shepherded the failed $24.6 billion takeover that’s now the focus of litigation between the two companies.
• PayPal Holdings Inc. will soon allow businesses to accept more than one hundred cryptocurrencies at checkout.
• Roche Holding AG plans to test whether an experimental medicine can prevent Alzheimer’s disease symptoms in high-risk people, its latest investment in one of the most failure-prone areas of drugmaking.
• Arrowhead Pharmaceuticals Inc. said Monday that it’s owed a $100 million milestone payment from Sarepta Therapeutics Inc. within the next two months, pressuring the beleaguered biotech company just days after it stopped selling its biggest drug due to safety concerns.
• EssilorLuxottica SA posted better-than-expected revenue in the second quarter, as the world’s biggest eyewear maker showed strong gains in Europe and pressed ahead with its smart-glasses initiative.
• Warner Bros. Discovery Inc. announced the names of the two companies resulting from a planned separation of the streaming and studios business from its cable-TV networks.

What Bloomberg Strategists say…

“A European trade deal and new China talks will go a long way to bolster risk sentiment in the days ahead, with the Aug. 1 deadline now largely irrelevant. With some level of framework in place for Europe, China and Japan, investors are gaining more visibility into the contours of global trade — and so far, they’re not particularly worried.”

—Tatiana Darie, Macro Strategist, Markets Live

For the full analysis, click here.

Some of the main moves in markets:

Stocks

• The S&P 500 was little changed as of 4 p.m. New York time
• The Nasdaq 100 rose 0.4%
• The Dow Jones Industrial Average fell 0.1%
• The MSCI World Index fell 0.3%
• Bloomberg Magnificent 7 Total Return Index rose 0.8%
• The Russell 2000 Index fell 0.2%

Currencies

• The Bloomberg Dollar Spot Index rose 0.8%
• The euro fell 1.3% to $1.1592
• The British pound fell 0.6% to $1.3355
• The Japanese yen fell 0.6% to 148.56 per dollar

Cryptocurrencies

• Bitcoin fell 0.6% to $118,128.17
• Ether fell 0.6% to $3,802.22

Bonds

• The yield on 10-year Treasuries advanced two basis points to 4.41%
• Germany’s 10-year yield declined three basis points to 2.69%
• Britain’s 10-year yield advanced one basis point to 4.65%

Commodities

• West Texas Intermediate crude rose 3% to $67.10 a barrel
• Spot gold fell 0.6% to $3,317.25 an ounce

©2025 Bloomberg L.P.

Introduction

A recent systematic review and meta-analysis considering 28 randomised controlled trials from the past 5 years comprising 2465 patients analysed the efficacy and safety of various presbyopia-correcting intraocular lenses (IOLs), including standard monofocal, bifocal, trifocal, extended depth-of-focus (EDOF) and enhanced monofocal IOLs after cataract surgery.¹ This study found that both trifocal and EDOF IOLs showed better uncorrected intermediate visual acuity (UIVA) than monofocal IOLs. They concluded that EDOF and enhanced monofocal IOLs have improved visual quality at intermediate distances and are a good choice if there are more activities in daily life at intermediate distances. The report published by the American Academy of Ophthalmology indicates that most multifocal and EDOF IOLs that were compared with a control monofocal IOL showed that patient-reported spectacle independence was superior to the monofocal IOL.²

Different EDOF IOLs have recently appeared on the market aiming to improve visual acuity at intermediate distances compared to monofocal IOLs. Several reviews and meta-analyses have been published showing their outcomes in comparison to trifocal models.^3,4 The Isopure 1.2.3. IOL (Beaver-Visitec International, Inc. [BVI], Waltham, USA) is an aspherical lens with an optical design based on an isofocal concept⁵ aiming to give patients good distance visual acuity with improved UIVA whilst inducing minimal photic phenomena. Different in vitro studies^6–10 have analysed this IOL and using an adaptive optics simulator it has been found that the Isopure IOL shows a good balance between depth-of-focus and visual acuity at distance.⁸ Different clinical studies have analysed this lens^11–22 and two studies with the largest sample of patients supported the optical bench assessments showing excellent distance-corrected visual acuity for far vision with improved unaided intermediate vision performance.^13,16 A new Isopure IOL model, named Isopure Serenity, has been launched on the market. This model is optically identical to the Isopure 1.2.3. IOL but with a different haptics platform. The Isopure Serenity shows a POD double C-loop posterior angulated haptic platform, which differs from the MICRO closed loop quadripode posterior angulated haptic of the Isopure 1.2.3 model. To our knowledge, there are no published studies reporting the clinical outcomes achieved either with this new IOL or with Japanese eyes. Therefore, the aim of the current study is to assess the visual and refractive outcomes in Japanese patients diagnosed with cataracts implanted with the Isopure Serenity IOL.

Methods

Study Design and Patients

In this clinical study, we prospectively examined 38 eyes from 19 patients at the Nihonbashi Cataract Clinic (Tokyo, Japan) between June 2024 and February 2025. The study was carried out in accordance with the tenets of the Declaration of Helsinki and was approved by the Nihonbashi Cataract Clinic Review Board. The inclusion criteria were cataracts, male or female adults aged 45 years or older on the day of treatment who were implanted with the Isopure Serenity IOL, maximum time between first and second eye treatment of 30 days, capacity to understand and sign the informed consent form and privacy authorisation and willing and able to conform to the study requirements. The exclusion criteria included age of patient <45 years at the day of surgery, time between first and second eye treatment >30 days, patients who underwent previous intraocular or corneal surgery other than IOL implantation, patients showing glaucoma, patients with diagnosed degenerative visual disorders (eg AMD), patients in whom surgical complications occurred (eg posterior capsule rupture) and patients in whom in-the-bag implantation was not possible.

Intraocular Lens

All eyes were implanted with the posterior chamber premium hydrophobic Isopure Serenity IOL (non-toric or toric model). This IOL is made of GFY hydrophobic acrylic material (refractive index = 1.53 and Abbe number = 42) with blue light and UV filter. The aspheric refractive optic design, based on an isofocal refractive concept, displays polynomial surface design parameters to extend the depth-of-focus compared to monofocal IOLs. The IOL shows the posterior angulated POD double C-loop haptic platform with RidgeTech. The optical zone of the lens is of 6.00 mm and the overall diameter is 11.4 mm. The spherical power ranges from +10.00D to +30.00D (in 0.50D steps) and from +31.00D to +35.00D (in 1.00D steps), and the cylindrical power at the IOL plane is of 1.00, 1.50, 2.25, 3.00, 3.75, 4.50, 5.25, and 6.00D.

Surgical Procedure and IOL Power Calculation

In this prospective study, the surgical procedure considered a phacoemulsification technique by means of the Centurion Phacoemulsification device (Alcon Labs, Fort Worth, TX, USA) through a 2.2 mm clear corneal incision with topical anaesthesia by an experienced surgeon (TA) using Phaco Prechop technique²³ following the standard procedure previously published.^24–26 In the case of toric lenses, the toric axis was marked by the Akahoshi Intra-operative Axis Marker with CCC Guide (ASICO AE-2933). IOL power was calculated using the Barrett Universal II formula and the target refraction was emmetropia in all eyes. The IOLMaster 700 swept-source OCT device (Carl Zeiss Meditec AG, Germany) was used to perform the optical biometry obtaining K1, K2, axis K1, axis K2, axial length, anterior chamber depth, lens thickness and white-to-white distance.

Visual and Refractive Measurements

At 3 months post-surgery the following visual metrics were recorded for distance, using the Sloan ETDRS tests (Precision Vision, Woodstock, IL, USA) on a LogMAR scale: monocular uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA); for intermediate (at 80 and 66 cm): UIVA and distance-corrected intermediate visual acuity (DCIVA); and for near (at 40 cm): uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA). Visual acuity at difference vergences was obtained by means of the photopic binocular best-corrected distance defocus testing for spherical additions ranging from –4.00D to +1.00D in 0.5D steps. Refraction (sphere, cylinder and axis) was recorded and the spherical equivalent (SE) was calculated. In addition, the vector analysis for outcome reports was conducted using the double-angle plot tool²⁷ considering the preoperative corneal astigmatism obtained from the IOLMaster 700 optical biometer and the refraction obtained at the last postoperative visit. Any adverse event or complication during surgery and follow-up were also recorded.

Statistical Analysis

For visual acuities and refraction parameters, the mean, standard deviation (SD), minimum and maximum values were calculated using the Excel software (2019, version 16.43, Microsoft Corporation, Redmond, WA, USA). Standard graphs for reporting refractive and visual acuity outcomes for IOL-based refractive surgery were plotted.²⁸

Results

Thirty-eight eyes of 19 patients implanted with the Isopure Serenity IOL were recruited in this study. Fourteen patients were female (73.68%). Patients’ demographics and preoperative characteristics are shown in Table 1. The mean patient’s age was 69.16 ± 10.28 years (ranging from 47 to 88 years). Neither surgical complications nor adverse events related to the IOL were reported in our sample during the study.

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

In order to report the refractive and clinical outcomes of this sample, we have constructed the standard graphs for IOL-based surgery. Specifically, for accuracy, Figure 1 was created showing the distribution of SE (Figure 1A) and refractive cylinder (Figure 1B) after the surgery. Note that the highest percentage of eyes, 65.79%, was for the range between ±0.13D followed by 18.42% for the +0.14 to +0.50D range. About 100% of the eyes were within ±1.00D and 89.47% of the eyes within ±0.50D. At 3 months, the mean SE and refractive cylinder were 0.12 ± 0.35D (ranging from 1.00 to –0.75D) and –0.11 ± 0.33D (ranging from 0.00 to –1.50D), respectively. For the vector analysis assessment, Figure 2 was plotted, showing the preoperative corneal astigmatism before the surgery (Figure 2A) and the postoperative refractive astigmatism at 3 months post-IOL implantation (Figure 2B). We may observe that the mean absolute of the corneal astigmatism before surgery was 0.58 ± 0.36D and that of the refractive astigmatism was 0.11 ± 0.33D after the intervention, showing its reduction.

Figure 1 Distribution of postoperative spherical equivalent refraction (A) and refractive cylinder (B) at three months post-Isopure Serenity intraocular lens implantation.

Figure 2 Double-angle plots for preoperative corneal astigmatism (A) and postoperative refractive astigmatism (B) at three months 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.

For visual acuity outcomes, Figure 3 was plotted. This figure shows the cumulative proportion of eyes at 3 months post-surgery with a given UDVA and CDVA (Figure 3A), UIVA and DCIVA (Figure 3B) and UNVA and DCNVA (Figure 3C) values. At the last follow-up visit (3 months), 34 (89.47%) and 37 eyes (97.37%) had 20/20 or better UDVA and CDVA, respectively, with 36 (94.74%) and 37 eyes (97.37%) achieving 20/25 or better UDVA and CDVA, respectively (see Figure 3A). Specifically, the mean values for UDVA and CDVA were –0.05 ± 0.08 and –0.08 ± 0.05 logMAR, respectively. Table 2 shows the mean values for all the visual acuity measurements. For intermediate visual acuity (see Figure 3B), 22 (57.89%) and 16 eyes (42.11%) achieving 20/32 or better DCIVA at 80 and 66 cm, respectively, with 31 (81.58%) and 23 eyes (60.53%) achieving 20/40 or better DCIVA at 80 and 66 cm, respectively. The mean values for DCIVA were 0.23 ± 0.13 and 0.28 ± 0.13 logMAR at 80 cm and at 66 cm, respectively (Table 2). At near vision (see Figure 3C), 10 (26.32%) and 10 eyes (26.32%) had 20/32 or better UNVA and DCNVA, respectively, with 23 (60.53%) and 21 eyes (55.26%) achieving 20/40 or better UNVA and DCNVA, respectively. The mean DCNVA (40 cm) was 0.35 ± 0.14 logMAR (Table 2). In addition, in order to evaluate the change in visual acuity at different vergences (defocus values), Figure 4 was created. This figure shows the postoperative photopic binocular through-focus, best-corrected visual acuity from 1.0D to –4.0D at 3 months post-surgery. As expected, the best visual acuity is obtained at distance focus (0D of vergence) with a reduction in its value with increased lens power. Values of about 0.20 logMAR showed a depth-of-focus of about 1.75D.

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 3 Cumulative proportion of eyes at three months 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).

Figure 4 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 at three months post-Isopure Serenity intraocular lens (IOL) implantation. Error bars represent standard deviation. The right y-axis shows Snellen feet acuity.

Discussion

New EDOF IOLs are increasingly being used by cataract and refractive surgeons. This type of IOL aims to provide a continuous range of vision offering good visual acuity at far and intermediate distances. As we have indicated, the Isopure 1.2.3. IOL has been widely studied in different clinical reports^11–22 showing good outcomes in terms of accuracy and visual acuity. The current study constitutes the first report on clinical outcomes with a new model, the Isopure Serenity IOL. The objective is to assess the refractive and visual performance of this lens in Japanese eyes and to compare it with previously published literature with the Isopure 1.2.3. IOL, specifically with two multicentre studies with the largest sample of patients of this IOL model: 183 eyes of 109 patients at 4 months carried out in Spain¹³ and 130 eyes of 65 patients at 4–6 months carried out in the Philippines, the Czech Republic and Spain.¹⁶

Analysing the refractive outcomes of the Isopure Serenity IOL obtained in the current study, 100% of the eyes were within ±1.00D and 89.47% of the eyes within ±0.50D (see Figure 1). The mean SE and refractive cylinder were 0.12 ± 0.35D and –0.11 ± 0.33D, respectively. These results are in agreement with those found by previous literature with the Isopure 1.2.3. IOL for Bernabeu-Arias et al¹³ with 95.7% of eyes within ±1.00D and 73.2% of eyes within ±0.50D and a mean postoperative SE of –0.12 ± 0.42D and a refractive cylinder of –0.46 ± 0.43D, and Ang et al¹⁶ with 99.23% of eyes within ±1.00D and 84.62% of eyes ±0.50D and a mean SE of −0.06 ± 0.36D and a refractive cylinder of −0.47 ± 0.37D. Then, we can consider both IOL models to be similar in terms of refractive accuracy. It should be considered that our cohort also includes Isopure Serenity toric IOLs. The Isopure Serenity shows a POD double C-loop posterior angulated haptic platform, which is the main difference with the Isopure 1.2.3. IOL model. This platform has been evaluated as showing excellent stability. This correlates with our good refractive outcomes in terms of spherical equivalent and astigmatism (see Figures 1 and 2). For example, a laboratory study assessing its mechanical stability using digital image correlation reported an axial displacement and tilt of 0.09 ± 0.06 mm and 0.76 ± 0.50 degrees against 0.09 mm and 1.74 degrees for a compression diameter of 9.50 mm.²⁹ Similar results were obtained for the other compression diameters. The results obtained are also comparable to in silico values (0.09 ± 0.06 mm versus 0.03 mm for a diameter of 9.50 mm), providing adequate mechanical stability for all the compression diameter range tested (11.00 to 9.50 mm).³⁰

Now focusing on visual acuity, we also found good outcomes (see Figure 3), with 89.47% and 97.37% of eyes having monocular UDVA and CDVA ≥20/20, respectively. Bernabeu-Arias et al¹³ found percentages of 50.82% and 76.57%, respectively, and Ang et al¹⁶ found values of 56.2% and 84.6%, respectively. The mean values in our cohort for UDVA and CDVA were –0.05 ± 0.08 and –0.08 ± 0.05 logMAR, respectively, and for Bernabeu-Arias et al¹³ 0.06 ± 0.12 and 0.01 ± 0.06 logMAR, respectively, and for Ang et al¹⁶ 0.06 ± 0.11 and –0.01 ± 0.08 logMAR, respectively. In general, our values were slightly better to those reported in both previously published cohorts. The outcomes for intermediate vision showed 57.89% and 42.11% of eyes achieving ≥20/32 DCIVA at 80 and 66 cm, respectively, with 81.58% and 60.53% of eyes achieving ≥20/40 DCIVA at 80 and 66 cm, respectively. The cumulative outcomes for monocular conditions in the Bernabeu-Arias et al¹³ study were 76.58% and 51.27% of eyes achieving ≥20/32 DCIVA at 80 and 66 cm, respectively, and in the Ang et al¹⁶ 94.6% and 71.5% of eyes achieving ≥20/32 DCIVA at 80 and 66 cm, respectively. In this case, the cumulative values in our cohort were lower than these two studies. Note that possible differences in the measurement method, pupil size of the patients or the specific-population ocular characteristics of the population may play a role in these differences. The mean values for DCIVA were 0.23 ± 0.13 and 0.28 ± 0.13 logMAR at 80 cm and at 66 cm, respectively. These values for the Ang et al¹⁶ study were better compared to ours, being 0.15 ± 0.11 and 0.19 ± 0.12 logMAR, respectively. In contrast, at near vision, 60.53% and 55.26% of eyes achieved a value ≥20/40 of UNVA and DCNVA, respectively, but with lower values in the Bernabeu-Arias et al¹³ study: 33.88% and 21.52% of UNVA and DCNVA, respectively, and similar to that found in the Ang et al¹⁶ study: 58.5% for DCNVA.

To ascertain how visual acuity changes with vergence (distance), Figure 4 shows the defocus curve under binocular conditions. This figure correlates with classical figures of defocus curve in this type of IOL showing a peak of best visual acuity located at 0D of defocus (far vision) and a smooth transition reduction with increasing negative lens power (closer distance to the eye). The good outcome is expected due to this lens maintaining good visual acuity at distance (>20/20 at 0D) while improving intermediate visual acuity (ranging from 20/32 to 20/20 between −1D and −2D vergence). Considering a 0.2 logMAR threshold, this lens offers a depth-of-focus of about 1.75D. Bernabeu-Arias et al¹³ and Ang et al¹⁶ also measured the binocular defocus curve showing both a peak at 0D with reduced values with closer distances. Bernabeu-Arias et al¹³ consider the depth-of-focus in their cohort to be about 1.50D, and Ang et al¹⁶ about 1.75D. The value obtained in our cohort is in agreement with these two studies. This amount of depth-of-focus provides our patients with good visual acuity at intermediate distances being useful for some daily life activities.

We want to indicate that our study has several limitations. The first is that we have included only one group, as this is a non-comparative design, and, therefore, the comparison was made with published literature by other authors. Our follow-up was 3 months and in spite of the fact that we consider this period long enough to study the performance of the lens, a longer follow-up is always desirable to confirm the early values. The analysis of centration and tilt of the IOL should be also analysed in future studies. And finally, it is interesting to consider other analyses that include quality of vision and patient satisfaction and photic phenomena questionnaires.

Conclusion

In conclusion, the present study shows that the new isofocal Isopure Serenity IOL with double C-loop haptics results in accurate refractive outcomes with excellent visual performance for distance vision and functional intermediate vision in Japanese eyes. This new IOL model performs similarly to the Isopure 1.2.3 IOL model, being an effective option to provide our patients with functional intermediate vision.

Disclosure

The author reports no conflicts of interest in this work.

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