The RayOne Galaxy Spiral IOL: What the FDA Trial and Published Studies Show

On September 24, 2026, the FDA approved the RayOne Galaxy and RayOne Galaxy Toric, a new presbyopia correcting lens implant from the British manufacturer Rayner. Rayner calls it "the world's first spiral IOL," and the launch has generated a lot of excitement, along with a lot of marketing language. Patients are already asking me about it.

The good news is that this lens arrives with real data. The FDA's 87-page Summary of Safety and Effectiveness is public, and several independent studies have been published. In this guide I go through what those documents actually show, including a few findings the press releases leave out, and how the Galaxy compares with the PanOptix, Vivity and PureSee lenses we already know well.

What Is the RayOne Galaxy?

During cataract surgery the cloudy natural lens is replaced with an artificial intraocular lens (IOL). A standard monofocal lens focuses at one distance. Presbyopia correcting lenses try to add computer and reading vision as well.

Most lenses that give strong reading vision, such as PanOptix, Odyssey and Envy, use microscopic concentric rings (a diffractive design) that split light into separate distance, intermediate and near focal points. The Galaxy takes a different approach. Its front surface carries a smooth, continuously changing spiral profile rather than rings, and Rayner describes it as non-diffractive. The goal is a continuous spread of focus from far to near, with less of the ring-shaped halo that diffractive lenses produce around lights at night.

Two points are worth knowing before reading any marketing:

• How it works is more nuanced than "the spiral." A detailed 2026 laboratory study by Dr. Damien Gatinel's group measured the lens with high-resolution interferometry and found that most of its extended focus comes from a carefully designed, rotationally symmetric optical profile (spherical aberration). The spiral itself contributes a smaller share. That does not make the lens less effective; it simply means "spiral" is not the whole story.
• The FDA classifies it as a multifocal (trifocal) lens. Rayner's materials use the phrase "full range of vision." The FDA-approved indication does not. It states that the lens "mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity."

The Galaxy (model RAO605G) is for eyes with less than 1.0 diopter of corneal astigmatism. The Galaxy Toric (model RAO615X) corrects roughly 1.0 to 3.0 diopters of corneal astigmatism. The lens is made of Rayner's hydrophilic acrylic material and comes preloaded in its injector. Rayner reports more than 200,000 implantations in 75 countries since its European approval in 2024.

What the FDA Trial Showed

The U.S. pivotal study was a randomized trial at 10 U.S. centers. 230 patients were randomized to receive the Galaxy in both eyes or Rayner's own monofocal lens (RayOne Aspheric, RAO600C) in both eyes, and were followed for four to six months. Testing was performed by examiners masked to which lens the patient had. Here are the key results, with logMAR scores converted to the familiar eye-chart equivalents.

The range of vision is real

The Galaxy improved reading vision by almost three lines on the eye chart compared with the monofocal lens, a large and highly significant difference. On the defocus curve, which tracks how sharp vision stays as objects move closer, Galaxy patients kept vision of about 20/32 or better all the way to roughly 40 cm (16 inches). Monofocal patients dropped below that level at about arm's length.

There is a distance trade-off

This is the part the headlines skip. Average best-corrected distance vision was slightly worse with the Galaxy, by about three letters on the chart. That passed the FDA's test for being "comparable," but the percentages tell the practical story: 43.6% of Galaxy eyes saw 20/20 or better with their best glasses, compared with 79.3% of monofocal eyes, and 29.4% of Galaxy patients saw 20/20 without glasses, compared with 68.8% of monofocal patients. Most Galaxy patients still saw well for driving, but crisp 20/20 distance was less common. That is a typical trade-off for lenses that deliver real reading vision.

Halos and night vision

On the validated Quality of Vision questionnaire, most visual symptoms occurred at similar rates in the two groups. Halos were the exception. At six months, 10.9% of Galaxy patients reported seeing halos "very often." Of the patients who noticed halos, 82% said they were not bothersome or only a little bothersome, and about 5.5% of all Galaxy patients were very bothered by them. In a separate, non-validated questionnaire, 26% of Galaxy patients reported trouble with night driving "often" or "always," compared with 16% of monofocal patients. The FDA cautions that this second questionnaire is descriptive only, but the direction is clear: the Galaxy is gentler than many older multifocals, and it is not the same as a monofocal at night.

Contrast sensitivity

Contrast sensitivity, the ability to see faint shades of gray in dim light, met the FDA's standard: it was no more than 0.3 log units worse than the monofocal at every spatial frequency tested. That means the loss stayed within an acceptable range. It does not mean contrast was identical.

Safety, and a finding worth knowing about

Overall complication rates were similar between the two groups, and no lens had to be removed because patients disliked the optics in either group. One retinal detachment occurred in a Galaxy eye, which is within the background rate after cataract surgery and not evidence of a lens-specific risk. In second eyes, one lens exchange in the Galaxy group was judged related to the lens.

The finding I discuss with every patient is the YAG laser rate. Within six months of surgery, 21.4% of Galaxy first eyes needed a YAG laser capsulotomy for posterior capsule clouding, compared with 7.0% of monofocal eyes (24.3% vs 7.9% in second eyes). A YAG laser capsulotomy is a quick, painless office procedure, so this is not a reason to avoid the lens. It is a reason to expect that a follow-up laser treatment is more likely. The FDA label now warns that patients with multifocal lenses may need YAG "earlier or more frequently," because even mild capsule haze is more noticeable with these optics.

What the FDA trial did not measure

• Glasses independence. The FDA summary does not report how many patients were fully free of glasses. Any specific "spectacle independence" percentage for the Galaxy comes from somewhere else.
• The toric version. There was no separate clinical trial of the Galaxy Toric. The FDA approved it based on the Galaxy trial combined with an earlier trial of Rayner's toric lens platform.
• A head-to-head comparison with other premium lenses. The control was a monofocal lens, so the trial cannot tell us whether the Galaxy is better or worse than PanOptix, Odyssey, Envy, Vivity or PureSee.

What the Published Studies Show

The European clinical series (Abela-Formanek et al., 2025)

Published in the Journal of Refractive Surgery, this two-part study by eleven European surgeons had healthy volunteers compare simulated Galaxy and RayOne Trifocal optics, then followed patients at 10 sites for three months after Galaxy implantation in both eyes. With distance glasses, average vision was about 20/19 at distance, 20/22 at intermediate and 20/24 at near in each eye, and binocular vision stayed at 20/32 or better from distance to about 35 cm. Halo and glare were reported as minor in more than 95% of patients. In the simulation, the Galaxy produced less halo than the trifocal. The study had no randomized control group and is closely associated with the manufacturer, which cites it in its marketing.

An independent Spanish series (Arias Puente et al., 2026)

Published in September 2026 in Graefe's Archive for Clinical and Experimental Ophthalmology, this prospective study followed 98 eyes of 49 patients for three months. With distance glasses, binocular vision averaged about 20/17 at distance, 20/17 at 66 cm and 20/26 at 40 cm, and functional vision (20/32 or better) extended from distance to about 40 cm. Contrast sensitivity improved and halo and glare perception decreased between the first and third months, consistent with the brain's adaptation to a new lens (neuroadaptation). These results are better than the FDA trial's, which is common for small single-center series. There was no comparison group.

The laboratory comparison: Galaxy vs PanOptix vs PureSee (Tommasi et al., 2026)

This optical bench study from the University of Florence tested the Galaxy, Alcon's PanOptix trifocal, J&J's TECNIS PureSee and a standard monofocal under controlled conditions at several pupil sizes. PanOptix showed three distinct focal points, as trifocals do. PureSee showed excellent distance quality with an extended intermediate range. The Galaxy behaved in between: with a large pupil it resembled the EDOF lens, and as the pupil narrowed its focus shifted toward near by about 0.75 diopters. Its measured halo was similar to PureSee and lower than PanOptix, though higher than a monofocal. A second bench study (Kim et al., 2026) found that intermediate and near performance drops notably when the pupil is larger than about 3.5 mm. In practical terms, the Galaxy's reading power is likely strongest in bright light, when the pupil is small.

Bench studies are useful for understanding how a lens behaves, but they test the lens in a laboratory, not in a patient. They cannot replace a clinical trial comparing the lenses in people.

How the Galaxy Compares to Other Premium Lenses

No randomized trial has yet compared the Galaxy directly with another premium lens. What we can do is set the FDA trial results for each lens side by side. These are different trials with different patients and questionnaires, so treat this as a rough guide rather than a ranking.

Reading the published evidence together, here is where I think the Galaxy sits today:

• Reading vision: clearly stronger than the EDOF lenses (Vivity, PureSee) and, on the FDA numbers, not as strong as a diffractive trifocal such as PanOptix.
• Computer vision: excellent, similar to Vivity and close to PanOptix.
• Distance vision: good, but its gap from its own monofocal control was larger than PanOptix's gap from its control.
• Halos: the laboratory studies suggest a halo pattern closer to an EDOF lens than to a trifocal. The FDA questionnaire numbers do not yet show a clear advantage over PanOptix, but the questionnaires were different, so the honest answer is that we do not know yet.

Put simply, the Galaxy is a promising middle option: more reading power than an EDOF lens, possibly with fewer halos than a trifocal. Rayner's claim of "low levels of bothersome dysphotopsia" compared with established lenses has not yet been tested head to head in patients, and its "0% loss of transmitted light" claim is a design statement from the manufacturer that does not appear in the FDA documents. The study that would settle the question, a randomized trial against PanOptix, Odyssey, Envy or PureSee, has not been done.

Our EDOF vs. multifocal comparison explains this trade-off in more depth, and our Lens Simulator & Guide (opens in a new tab) lets you see a daytime scene and a night driving scene through monofocal, EDOF and multifocal designs.

Who Might Be a Good Candidate?

Based on the evidence so far, the Galaxy may suit patients who:

• Want good computer and reading vision without glasses for most daily tasks
• Are worried about halos with a diffractive trifocal but want more reading vision than an EDOF lens provides
• Are comfortable with slightly less crisp distance vision than a monofocal would give, and accept that readers may still help for fine print in dim light
• Have healthy eyes: a clear cornea, a healthy macula and optic nerve, and a good tear film (or are willing to treat dry eye before surgery)
• Have astigmatism within the toric range, which the Galaxy Toric can correct in the same surgery

We are more cautious with any presbyopia correcting lens when a patient has moderate or advanced glaucoma, macular degeneration, an irregular cornea, or does a great deal of night driving and is very sensitive to glare. For those patients a non-diffractive EDOF lens or a monofocal, sometimes with mini-monovision, is often the better plan.

What Does the Galaxy Cost?

Medicare and most insurance cover the standard portion of cataract surgery, which includes a quality monofocal lens. The Galaxy is a presbyopia correcting premium lens, so the upgrade is paid out of pocket, the same as PanOptix, Odyssey, Envy or PureSee. Nationally, premium lens packages commonly add roughly $1,500 to $3,500 per eye beyond the covered portion. Because the Galaxy only became available in the United States in late September 2026, ask us for current pricing at your consultation.

My Take

The Galaxy is a genuinely new optical idea, and its FDA trial was well run: masked, randomized and transparent about its results. The data show a real gain in computer and reading vision, a modest cost in distance sharpness, halos that are mostly mild, and a noticeably higher chance of needing a YAG laser treatment. What we do not yet have is the head-to-head clinical trial that would show whether the Galaxy truly gives trifocal-level reading with EDOF-level nights. Until then, I see it as a promising addition to the menu rather than a replacement for the lenses we already trust.

At Eye MDs of Inland in Upland, every lens recommendation begins with measurements: corneal topography, optical biometry, a tear film evaluation, and imaging of the macula and optic nerve. Then we talk about your day, your night driving, and how you feel about readers. If you are curious about the Galaxy, bring this article to your visit and we will go through whether it, or another lens, fits your eyes best.

Works Cited

1. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data: RayOne Galaxy and RayOne Galaxy Toric (PMA P060011/S045). Approved September 24, 2026.
2. Abela-Formanek C, Amon M, Auffarth GU, et al. Performance of the first spiral refractive intraocular lens for continuous full range of vision. Journal of Refractive Surgery. 2025;41(11):e1213-e1222.
3. Arias Puente A, Carrero Collantes A, Rincón Rosales JL, Infiesta-Valderrey L, Piñero DP. Clinical outcomes of a new presbyopia-correcting intraocular lens with spiral optic. Graefe's Archive for Clinical and Experimental Ophthalmology. Published online September 19, 2026.
4. Tommasi F, Giorgetti A, Gurioli M, Mariñas-Garcia L, Cavalieri S, Ruiz-Alcocer J. Optical performance of a novel non-diffractive presbyopia-correcting intraocular lens as a function of defocus and pupil size. Journal of Refractive Surgery. 2026;42(7):e701-e709.
5. Gatinel D, Entin A, Stern B. In vitro optical characterization of the RayOne Galaxy spiral EDOF IOL using high-resolution Mach-Zehnder interferometry. Biomedical Optics Express. 2026;17(7):3984-4001.
6. Kim DH, Son HS, Wu Z, Auffarth GU, Łabuz G. Estimating range of vision and optical function related to pupil size in a spiral intraocular lens. Journal of Refractive Surgery. 2026;42(6):e514-e521.
7. U.S. Food and Drug Administration. Summaries of Safety and Effectiveness Data for AcrySof IQ PanOptix (P040020/S087, 2019), AcrySof IQ Vivity (P930014/S126, 2020) and TECNIS PureSee (P980040/S176, 2026).
8. Rayner. Rayner announces FDA approval of Galaxy, the world's first spiral IOL. Press release, September 24, 2026.