Numbers With Nuance: EU Clinical Trial Spotlight at ESCRS 2025

The session cracked open the future, showing how evidence is already reshaping everyday sight.

On Day 3 of the 43rd Congress of the European Society Of Cataract & Refractive Surgeons (ESCRS 2025), the EU Clinical Trial Spotlight Symposium felt anything but quiet. Chaired with verve and rigor by Prof. Mor Dickman (The Netherlands) and Dr. Joaquín Fernández (Spain), the session stitched together fresh randomized data, post-market evidence and a candid look at how real-world registries can (and should) reshape cataract and refractive care. 

It was a morning of numbers, yes, but more importantly, of clinical nuances: who truly benefits, under what conditions and how we talk to patients about the inevitable trade-offs.

READ MORE: Eyeing Big Data

A full visual range, minus the drama?

Kicking off, Dr. Cathleen McCabe (United States) brought the room a prospective, multicenter, randomized controlled pair of trials on Bausch + Lomb’s (Ontario, Canada) EnVista Envy—a full visual range intraocular lens (IOL) built on an apodized diffractive anterior surface and an aspheric, biconvex optic. 

The design choices here matter. The diffractive steps taper as they march toward the periphery, redistributing light toward distance vision as the pupil dilates and aiming to temper dysphotopsias—the halos, glare and starbursts that can sour even excellent acuity.

And she brought the data to prove it. Two parallel, multicenter, prospective, randomized controlled trials across the United States and Canada compared the EnVista Envy (an apodized diffractive full-range IOL) against a standard monofocal lens. 

READ MORE: How Bausch + Lomb is Safely Returning enVista® IOLs to the Market Weeks after TASS Recall

At distance, the Envy met non-inferiority versus monofocal performance. At intermediate, the advantage was striking: 95% achieved 20/40 or better, compared with just 50% in the monofocal group.¹ 

Near acuity added a transformative edge, delivering a four-line gain—the kind of difference that changes how patients interact with phones, menus and dashboards in daily life. Underpinning the toric results was excellent rotational stability, driven by broad capsular bag contact and haptic compression, which maintained performance across a wide dioptric range.¹

But the mood lift came from the subjective side. Dr. McCabe delivered the line many surgeons wanted to hear: “Greater than 80 percent of patients with Envista Envy had little to no bothersomeness to dysphotopsias, meaning halos, glare and starbursts.” 

In an arena where “premium” too often reads as “compromise,” those patient-reported outcomes landed. She was careful, though, to remind us that diffractive optics still demand thoughtful case selection—especially in eyes with optic nerve or macular concerns—and that our shared vocabulary (continuous vs. smooth range) is evolving as fast as the tech.

EDOF without rings—and without flinching

From diffractive to different. Dr. José Manuel Díez del Corral (Spain) stepped up next with interim, real-world results from the multicenter post-market Prelude study of Johnson & Johnson’s (New Jersey, United States) TECNIS PureSee, an EDOF IOL that avoids diffractive rings and instead sculpts a smooth, continuous power change within a central 2.4-mm posterior zone. 

The engineering ambitions are straightforward: extend depth of focus, preserve contrast and keep the dysphotopsia profile near-monofocal.

WATCH NOW: Dr. Naren Shetty Dives Deep into J&J’s TECNIS PureSee™ IOL’s Clinical Performance

Across 466 eyes at three months, binocular outcomes were crisp at distance (mean ≈ logMAR −0.02), strong at intermediate (~0.12), and—crucially—better-than-“functional” for near (~0.22–0.25), with an overall spectacle independence of 85% and low bothersomeness for halos, glare and starbursts (>90% reporting none or only a little).²

It’s the kind of data that changes pre-op chair time: surgeons can have more affirmative conversations with patients who dread rings and glare, without pretending any lens is completely symptom-free.

A monofocal that behaves well when pupils misbehave

If you thought monofocals were done surprising us, Dr. Seth Pantanelli (United States) had other ideas. Presenting interim results from the PRECISE trial (NCT06428955) on ZEISS’s (Jena, Germany) CT LUCIA 621P IOL, he spotlighted an aspheric profile that varies with pupil size: negative spherical aberration centrally to neutralize the cornea under small pupils, sweeping toward neutral/positive peripherally for mesopic dilation or decentration. 

The data aligned neatly with the design story. Binocular distance hovered near 20/20 in both photopic and mesopic conditions, and an eyebrow-raising ~90% achieved functional intermediate vision (≈20/32 or better). 

That’s not a “monofocal plus” claim; it’s an acknowledgment that modern aspheric engineering can preserve distance quality while giving patients meaningful arm’s-length function, particularly relevant in the age of dashboards, laptops and supermarket shelves. Refractive predictability was tight, too, with the bulk of eyes landing within ±0.50 D.³

Take-home: in patients where diffractive optics raise red flags (ocular surface fragility, suspicious maculae, vocational night driving), a thoughtful monofocal may deliver more of the day-to-day function than we used to give it credit for, without inviting a dysphotopsia debate.

Turn down the pressure, turn up the comfort

From optics to operating rooms, Dr. Matthew Rauen (United States) brought a clinically intuitive question under a hard light: what happens when we bring intraoperative IOP closer to physiologic levels during phaco? 

Using Alcon (Geneva, Switzerland) Centurion’s active fluidics platform, he presented data from a comparative study that evaluated intraoperative low versus high IOP in contemporary phaco systems.

READ MORE: Alcon Rolls Out UNITY VCS and CS Systems for Cataract and Vitreoretinal Surgery

The findings are persuasive and practical. Lower IOP conditions correlated with less corneal thickening, better endothelial cell preservation, reduced early anterior chamber flare and cells, less disturbance at the anterior hyaloid/Wieger’s space interface, and, importantly for patient experience, meaningfully lower intraoperative discomfort, with fewer rescue analgesics.⁴ 

Reverse pupillary block occurred less often and less intensely. Efficiency didn’t tank: case times and aspiration durations were similar, while cumulative dissipated energy trended lower.⁴

Dr. Rauen’s discussion with the chairs ventured into culture change. If lower IOP improves tissue respect and comfort without hurting flow or control, why cling to 80 mmHg just because “we’ve always done it”? 

His closing philosophy could have been the session’s north star: “I think less is more.” Expect fluidics-forward platforms to keep pushing this envelope—and expect patient-experience metrics (ask them!) to become standard endpoints, not afterthoughts.

Registries: the common language we’ve been missing

Finally, Dr. Anders Behndig (Sweden) zoomed out to infrastructure—the scaffolding that turns promising studies into durable practice. Post-marketing surveillance, by FDA definition, is about scientifically valid, real-world collection and interpretation. Registries do exactly that, at scale, across ordinary patients and edge cases alike.

Dr. Behndig outlined the ESCRS Registries ecosystem—URIQUO (adult cataract/refractive), ECCTR (cornea) and EUREQ (pediatric cataract)—and, crucially, an industry task force meant to co-create standardized datasets and Patient Reported Outcome Measures Dataset (PROMS) that actually capture what today’s lenses promise (think: dedicated intermediate vision items, glare/halo bother, night-driving function). 

Instead of each company spinning up boutique databases, the call is to partner with a shared platform; leverage governance, minimize duplication and make the resulting evidence generalizable and comparable. It’s not about regulatory box-ticking, Dr. Behndig argued; it’s about public value—faster learning loops, sharper guidelines and better patient matching.

Less pressure, more physiology

As the session closed, you could feel the Copenhagen clarity seep into the clinical psyche: fewer buzzwords, more mechanisms; fewer assumptions, more patient-reported truth; fewer heroic pressures, more physiology. The promise isn’t perfect vision—it’s predictable vision, across lighting, life and the long tail of real-world variation.

Editor’s Note: The 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2025) is being held from 12-16 September in Copenhagen, Denmark. Reporting for this story took place during the event. This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.

References 

1. Shultz MC, Wiley WF, Liang E, Epitropoulos AT, Whitman J. Visual and patient-reported outcomes of a novel full visual range IOL versus a monofocal IOL: A randomized multicenter US trial. Am J Ophthalmol. 2025:S0002-9394(25)00465-9.

2. Alfonso-Bartolozzi B, Martinez-Alberquilla I, Fernández-Vega-Cueto L, et al. Optical and Visual Outcomes of a New Refractive Extended Depth of Focus Intraocular Lens. J Refract Surg. 2025;41(4):e333-e341. 
3. The study can be found on clinicaltrials.gov with ID number NCT06428955. 
4. The study can be found on clinicaltrials.gov with ID number NCT06325397.