Where Are We Going With IOL Technology?

To be on the cutting-edge of optometry, we need to also be on the cutting-edge of science and technology. No matter where our specialties or passions lie, technology is constantly advancing to help us improve patient care.

When it comes to cataract surgery, there are many innovative IOL technologies that provide both quality and quantity of vision. We have witnessed these advances over the past 20 years, from the early refractive IOLs to the current trifocal and extended depth-of-focus (EDOF) IOLs, and these will only continue to improve. From today’s advanced monofocal IOLs, to toric IOLs, to multifocal/diffractive/EDOF IOLs, there are many options from which our patients can choose, so it’s important that we stay current on the latest offerings. This article reviews recently approved IOL technologies as well as those in the pipeline.

NEXT-GENERATION MONOFOCAL IOLS

FDA-Approved

• The Tecnis Eyhance IOL (Johnson & Johnson Vision Care) is a monofocal lens with a slightly extended depth of focus that delivers both distance and intermediate vision. The Tecnis Eyhance IOL is limited at the near range of vision because it doesn’t have diffractive rings like other multifocal IOLs, which improves its quality of night vision with much less risk of glare and halos. Ideal patients are those wanting some extended depth of focus with considerations for those with macular degeneration, glaucoma, or other ocular pathologies who wouldn’t be candidates for other presbyopia-correcting IOLs. The Tecnis Eyhance IOL received FDA approval in February 2021.

In one study, 139 patients were bilaterally implanted with the enhanced monofocal IOL (n = 67) or a standard monofocal IOL (n = 72). The enhanced monofocal IOL significantly improved mean monocular and binocular distance-corrected intermediate visual acuity and uncorrected intermediate visual acuity by at least 1 line logMAR versus the standard monofocal IOL at the 6-month visit (all P ≤ .0001).¹

• The RayOne EMV (Rayner) is a UV light-absorbing one-piece IOL intended for placement in the capsular bag using the RayOne injection system. It offers reduced dysphotopsia, which is achieved through a unique aspheric anterior surface that adds to the positive spherical aberration (SA) of the cornea in a controlled manner. This positive SA smoothly transitions to negative SA at the periphery to prevent reduced image quality from positive SA at larger pupil sizes. Patients with larger pupils may not be ideal candidates.² This blended transition between the dominant and nondominant eyes, when compared to monovision achieved with standard monofocals, maintains binocular stereoacuity and reduces asthenopia. The RayOne EMV IOL received FDA approval in March 2021.

• The IPure (Beaver-Visitec International) is the first and only preloaded aspheric monofocal IOL available in both a one-piece and three-piece design. IPure’s patented aspheric optic design provides high contrast sensitivity in various lighting conditions, maintains natural corneal depth of focus, and is less sensitive to natural off-axis conditions, lens decentration, and corneal aberrations. The IPure IOL can provide high quality vision to any patient, but this lens is a great choice in particular for individuals with aberrated corneas, including those with a history of laser vision correction and those with keratoconus.

The IPure is a modified spherical aberration lens, and has the benefits of both a spherical and a negative aspheric IOL. The three-zone aspheric optic of the IPure is designed to increase depth of focus.³ The 2.4-mm central optical zone (zones 1 and 2) has neutral spherical aberration, providing better contrast sensitivity than a standard aspheric IOL. Within zone 1, which is the very center of the optic, the spherical aberration is slightly positive. The peripheral optic zone (zone 3) has -0.18 µm spherical aberration.

In the Pipeline

Because there are so many monofocal IOLs in the pipeline, our overview of this category is limited to only those recently approved.

ACCOMMODATING IOLS

FDA-Approved

There are no newly approved IOLs to mention at this time.

In the Pipeline

• Juvene (LensGen) is a two-part accommodating IOL that is comprised of two components: a base lens and a fluid lens (Figure 1). The natural crystalline lens can change shape as the ciliary muscles contract and the zonules relax. This fluid optic IOL mimics a natural lens by changing shape as the ciliary muscle contracts and relaxes, changing the shape of the modular. The Juvene IOL provides accommodation of up to 3.00 D of continuous range of vision. Other advantages include no posterior capsular opacification for up to 4 years, no splitting of light, and no change in effective lens position.

In the 17 patients (34 eyes) implanted with the Juvene IOL in the Grail clinical study, binocular defocus curves showed a wide range of vision with both eyes corrected for plano distance (best distance-corrected near visual acuity and distance-corrected intermediate visual acuity). Study participants achieved a mean 20/25 intermediate vision at 60 cm and 20/32 near vision at 40 cm.⁴ The Juvene IOL received investigational device exemption approval from the FDA in November 2021 to begin human clinical trials.

• The liquid silicone-filled FluidVision IOL (Alcon, formerly PowerVision) changes shape to allow clear vision at all distances with accommodation of about 2.00 D (Figure 2). As the ciliary muscles constrict when we attempt to focus at near, fluid inside the haptics gets pushed into the optic section of the IOL, causing a change in the curvature of the lens to allow near vision. When focusing at distance, the ciliary muscles relax, causing the fluid to move back towards the haptics, once again changing the shape of the lens to mimic a natural lens with no accommodation.

In a multicenter pilot clinical study involving 27 patients who underwent monocular implantation of the FluidVision IOL, the mean best monocular corrected distance VA in eyes with the lens was stable at -0.05 logMAR (> 20/20) at 6 months’ follow-up. In addition, the average distance-corrected intermediate and near VAs were 0.05 logMAR (20/22) and 0.14 logMAR (20/27) for the same period. The average accommodative amplitude at 6 months, measured by autorefractor, was nearly twice that achieved by the earlier-generation FluidVision lens. The average accommodative amplitude was 2.00 D, although some eyes achieved objective accommodation up to 4.10 D.⁵

• The Lumina (AkkoLens) accommodative IOL consists of two progressive optical elements that change its focal power by moving across each other in a plane perpendicular to the optical axis (Figure 3). Implanted in the sulcus through a 2.8-mm incision using a special injector, the lens’ haptics directly contact the ciliary muscles. This change in shape of the IOL allows 3.00 D to 4.00 D of focal range when accommodating without compromising contrast sensitivity. This IOL also has a decreased risk of glare and halos with night vision compared with multifocal IOLs, which also provide improved near vision.⁶

In a study by Alio et al, uncorrected and corrected distance VAs did not differ significantly between the treatment and control groups (P ≥ .21) over the 12 months. However, the uncorrected near VA was 0.07 + 0.08 logRAD for the Lumina group and 0.37 + 0.19 logRAD for the control group (P < .01) and corrected distance near VA was 0.11 ± 0.12 LogRAD for the Lumina group and 0.41 ± 0.15 LogRAD for the control group (P < .01). Defocus curves showed a statistically significant difference between groups for defocus ranging from -4.50 D to -0.50 D (P < .01) with significantly higher visual acuities for the Lumina group.⁷

• The JelliSee IOL (JelliSee Ophthalmics) is one of the newest accommodating IOLs still in clinical trials (Figure 4). The technology used in this lens aims to mimic natural accommodation and relaxation by allowing the lens to change shape as the ciliary muscles relax for distance viewing and constrict for near viewing. With only a 0.2-mm change in diameter, it can achieve up to 6.00 D of accommodation with smooth transitions at all ranges and minimal dysphotopsias.⁸ The amount of accommodation it provides with such minimal change in shape allows this lens to continue focusing at near even after capsular fibrosis occurs. Anyone who is presbyopic qualifies as a candidate for this IOL, regardless of any corneal, retinal, or macular pathology that would typically disqualify them from most multifocal and EDOF IOLs.

EDOF AND TRIFOCAL IOLS

FDA-Approved

There have been no new approvals in this category in the past 2 years.

In the Pipeline

• FineVision Triumf (BVI) is the first EDOF hydrophobic trifocal IOL to offer a unique, elongated depth of focus covered by longitudinal chromatic aberration (LCA) correction, which provides quality of vision at all distances and reduces the risk of side effects such as photic and negative dysphotopsia phenomena (Figure 5). LCA would be clinically deleterious for contrast sensitivity under white light conditions. The reduction of LCA can be beneficial for the quality of vision, providing patients enhanced image quality across a wide and extended range of focus. The modified energy distribution of the FineVision EDOF technology displays an elongated depth of focus, creating a smooth transition of energy over all distances and offering a “physiological” energy distribution with vision at all distances.⁹

• The RayOne Trifocal (Rayner) is a diffractive trifocal design that has fewer rings on the optic surface for reduced potential visual disturbances and improved night vision (Figure 6). The company’s patented diffractive step trifocal technology reduces light loss to only 11% so that 89% of light is transmitted to the retina with a pupil of 3.0 mm. Half of the light is allocated for the distance and the remaining light is divided between distance and near.

• The Sulcoflex Trifocal supplementary IOL (Rayner) is an adjustable option that allows you to treat an even wider range of patients for presbyopia to meet both their visual and lifestyle needs. Indications for this procedure are for pseudophakic presbyopia correction, post-surgical ametropia, and patients who have experienced a change in their postoperative refraction. The Sulcoflex Trifocal features Rayner’s patented trifocal optics, with a +3.50 D add for near vision and +1.75 D add for intermediate vision.¹⁰

Raynor has also developed the Duet procedure, which involves both a monofocal implanted within the capsular bag, targeting emmetropia, followed by a plano Sulcoflex Trifocal. This procedure can be performed simultaneously at the initial surgery, a few weeks apart once the residual refractive error is determined, or as a standalone procedure with the patient’s original monofocal IOL. The goal of the procedure is to provide increased spectacle independence.¹⁰

IN A LEAGUE OF THEIR OWN

FDA-Approved

• The one-piece, small-aperture IC-8 Apthera IOL (Acufocus) uses a pinhole design to provide up to 3.00 D of functional vision. The small aperture provides an increased depth of focus and depth of field. The design is a monofocal IOL with an embedded black circular mask that blocks out unfocused rays of light to avoid distortion and blur. The pinhole effect created by the smaller aperture allows light rays to focus more precisely on the retina.

In FDA clinical trials, 453 participants were enrolled and followed for 12 months. Outcomes for the Apthera IOL group (n = 343) were compared to a control group (n = 110) receiving a monofocal or monofocal toric IOL OU. Apthera IOL-treated eyes maintained 2.00 D of EDOF and demonstrated 0.91 D of additional range of vision benefit over monofocal IOL eyes at 0.2 logMAR threshold, exceeding the 0.50 D ANSI criterion for EDOF IOLs.¹¹

This IOL received FDA approval in July and is a great option for those who might not be able to qualify for EDOF or multifocal IOLs due to corneal irregularities, such as previous corneal transplants, keratoconus, or distorted vision due to prior iris trauma. This lens is also beneficial for those with mild to moderate astigmatism, as it cancels out the degradation of vision for up to 1.50 D of cylindrical refractive error. Due to its small aperture, side effects of glare and halos are minimal for patients who receive this lens, providing them with excellent nighttime vision. The IC-8 Apthera is the first and only nontoric EDOF IOL approved for the 82% of cataract patients who have as much as 1.50 D of corneal astigmatism.¹²

In the Pipeline

• Perfect Lens (Perfect Lens) uses a femtosecond laser to change the refractive power of any previously implanted IOL. This is a great option for patients who are dissatisfied with their visual outcome or who changed their minds and desire a different refractive goal. The Perfect Lens can be used to change the refractive power of a preexisting IOL by up to 3.60 D and can change a lens from a multifocal to monofocal, and vice versa.¹³ One of its unique advantages includes not only being able to make refractive adjustments, but also being able to reverse those adjustments, if necessary.

A RESPONSIBILITY NOT TO BE TAKEN LIGHTLY

With the current IOL technologies available and more on the way, how do patients choose? This is the perfect opportunity for the comanaging optometrist to step in and help patients navigate their cataract journey.

From the initial diagnosis of early cataracts to the decision to have surgery, we can help create excitement and momentum for our patients through education. The more educated patients are throughout their cataract journey, the higher the satisfaction we will deliver. Just remember: Not all patients will be candidates for advanced technology IOLs, so we have to match the patient to the technology and the technology to the patient. This is our time to help our patients make a once-in-a-lifetime decision that will help improve their quality and quantity of vision.