Medical device manufacturer Rayner announced it has concluded recruitment for the U.S.-based investigational device exemption (IDE) study of the RayOne Galaxy intraocular lens (IOL), a new premium lens solution.
First up: Rayner.
Based in the United Kingdom—with U.S. headquarters in Memphis, Tennessee—Rayner specializes in offering an ophthalmic product portfolio of IOLs (including monofocal, trifocal, toric, and a range of other types) as well as:
See here for more product offerings.
And we can’t not mention: Rayner actually launched the first-ever IOL in collaboration with ophthalmologist Harold Ridley, MD, in London in 1949.
Now talk about the RayOne Galaxy IOL.
The RayOne platform consists of both the RayOne Galaxy and RayOne GalaxyToric—both fully preloaded, next-generation IOLs—feature a first-ever spiralized design developed via a proprietary artificial intelligence (AI)-based engine trained on patient outcomes.
Notably: This non-diffractive spiral optic is intended to provide “optimized visual acuity (VA)” with a design that delivers:
- A smooth and continuous full range of vision
- +0.5 D to –2.5 D
- Binocular defocus VA of ≥ 0.2 logMAR across a range of ~4.0 D
- Less halo to minimize dysphotopsia
- 0% loss of transmitted light
- Toric power options
What is it made out of?
The company’s patented material: a single-piece Rayacryl hydrophilic acrylic.
- What this is: A copolymer of hydrophilic and hydrophobic methacrylates.
Properties of this material include:
- Soft and easy to handle
- Low inflammatory response
- Low refractive index (than hydrophobic acrylic IOLs)
- Vacuole free
Other technical specifications:
- Water content (26% in equilibrium)
- Ultraviolet (UV) protection (benzophenone UVA absorbing agent)
- UV light transmission (UV 10% cut-off at 380 nm)
Tell me more about this spiral design.
As we previously reported, a spiral-shaped IOL—similar in design and concept to that of the RayOne Galaxy—was the subject of clinical research published in Optica in early 2024.
Though this study has not been confirmed to involve Rayner’s IOL specifically, it gives a deeper look into the development, efficacy, and overall mechanics of the unique figuration.
And how does it compare to a trifocal IOL?
Rayner noted three key distinctions, with the RayOne Galaxy showing:
- No surface steps or discontinuities
- No discrete annual zones
- A smooth optic surface
Alrighty, let’s get into this IDE study.
We’ll start with the “IDE” portion of the trial, which essentially allows an investigational device (the RayOne Galaxy IOL, in this case) to be used in a clinical trial to collect safety and effectiveness data.
An IDE clinical study is most often conducted to support a premarket approval (PMA), which is the FDA’s review process for evaluating Class III medical devices prior to receiving regulatory approval.
- Important to note: All clinical evaluations of such devices must have an IDE in place prior to a study’s initiation.
Now, what do we know about the study?
The prospective, multicenter, randomized, masked, active-controlled study began implanting the RayOne Galaxy in patients in the United States over a year ago.
Aside from the company’s recent announcement that it has completed recruitment (just 18 weeks after the first IOL explanations), here’s what we know:
- The study is evaluating the RayOne Galaxy IOL and a monofocal control
- Participant demographics: all patients are indicated for cataract surgery
- The last patient follow-up point was 4 to 6 months
- Expected timeline for a data release: Likely not until the potential device approval (tentatively expected in 2026
As an aside: Rayner also previously concluded enrollment in a separate IDE study for its RayOne EMV Toric IOL last year (June 2024) to support a PMA in the U.S.
Gotcha. Well, is there any clinical trial outside the U.S. that has evaluated the IOL?
There is! In fact, a pre-launch clinical evaluation was conducted by 10 surgeons from 10 countries.
Those details: 180 eyes were treated with both the RayOne Galaxy and RayOne Galaxy Toric IOLs.
- Investigators obtained postoperative clinical outcomes at Months 1 and 3.
The interim data (as of Jan. 15, 2025): Rayner reported the RayOne Galaxy IOLs provided:
- A full range of vision—notably: “without the wave-like defocus pattern associated with diffractive trifocal IOL.”
- Mean corrected and uncorrected visual acuities (VA) at all distances of 0.1 logMAR or better
- Binocular defocus curve VA of 0.2 logMAR or better across a ~4.0 D range
- Less halo and glare (compared to current published data on diffractive trifocal IOLs)
- Specifically: A preclinical study involving 30 patients with healthy eyes found “RayOne Galaxy demonstrated a halo size closer to that of an enhanced monofocal IOL than a diffractive trifocal IOL,” according to the company.
The European results definitely sound promising.
They were. In fact, Rayner reported those findings from that study while also launching (as a limited release of selective surgeons) the RayOne Galaxy and Galaxy Toric IOLs at the 2024 European Society of Cataract and Refractive Surgery (ESCRS) Congress in August 2024.
See the company’s clinical data presentation from the meeting.
And more recently: Just last month, the company announced the full commercial release of the IOLs (excluding in the U.S.).
Any feedback from surgeons on the IOLs yet?
Yes! In fact, Francesco Carones, MD, a clinician who participated in the RayOne Galaxy’s pre-launch clinical phase of implantations, noted: “It was immediately apparent that this IOL can provide a long range of focus with minimal compromises on the quality of night vision.”
- As a bonus: See here to hear from surgeons and their patients who have undergone implantations of the IOLs.
And the U.S.-based feedback so far: Vance Thompson, MD, of Vance Thompson Vision in Sioux Falls, South Dakota—who noted that “the first case went very well” after performing the first implantation of the U.S. IDE study—expressed clinicians’ eagerness to implant the IOL following encouraging early experience in Europe.