IOL designs, not to mention material and optics, continues to yield intriguing new presbyopia-correcting technology as the search continues for the ideal combination that can replace natural accommodation and maximize spectacle independence. Three trends — in some cases combined in a single platform — are at the forefront: accommodation without compromise, modularity that allows for postoperative adjustments and shape-changing.

Here’s a look at the US pipeline of presbyopia-correcting IOLs.

FLUIDVISION

The FluidVision lens (PowerVision acquired by Alcon) comprises a hydrophobic acrylic shell filled with index-matched silicone oil. This allows it to change shape to provide clear vision at all distances with accommodation of about 2.00 D, the manufacturer says. As the ciliary muscles constrict with near focus, fluid inside the haptics is pushed into the optic section of the IOL, causing a change in the curvature of the lens. The ciliary muscles relax when focusing at distance, causing the fluid to move back toward the haptics, mimicking a natural lens with no accommodation.

In a multicenter pilot clinical study involving 27 patients who underwent monocular implantation with the FluidVision IOL, the mean monocular BCDVA in eyes with the lens was stable at -0.05 logMAR at 6 months.¹ The monocular distance-corrected intermediate visual acuity (DCIVA) and near VA (NVA) was 0.05 logMAR (20/22) and 0.14 logMAR (20/27) for the same period. The average accommodative amplitude at 6 months was nearly twice that achieved by the earlier-generation FluidVision lens, according to the company. The average accommodative amplitude was 2.00 D, although some eyes achieved objective accommodation up to 4.10 D.

GEMINI REFRACTIVE CAPSULE

Omega Ophthalmics’ Gemini Refractive Capsule was designed to address the possibility of keeping the capsular bag open to not only add additional lens technologies, but also for a drug-delivery system or biometric sensors. The 3-D capsule, implanted through a 2.2-mm incision, accepts a proprietary, exchangeable optic and maintains an open space. With the Gemini capsule inserted into the capsular bag, a standard C-haptic multifocal or monofocal IOL can be placed into the capsule. A piggyback lens could be added later, or the lens could be exchanged. The capsule fills the bag and centers correctly, thereby providing a stabilizing effect for IOLs and making the Z-axis of the IOL more predictable, the manufacturer says.

The first in-human experience from eight patients implanted with the capsule at the time of cataract surgery was reported at the 2018 ASCRS meeting.² At 1, 3 and 6 months postoperatively, mean BCDVA was 0.1 logMAR. At 6 months postoperatively, four of the eight patients with residual refractive errors elected to receive a secondary IOL to improve UCVA. At 1 and 3 months after the piggyback IOL procedure, distance UCVA was 0.13 logMAR.

Additionally, Gary Wörtz, MD, the inventor, founder and CMO of Omega, says, “Omega Ophthalmics has completed 30 implantations of their current device with safety and efficacy data out to 12 months showing excellent results (meeting the primary endpoint and showing no ongoing adverse events).”

“The Omega Gemini Capsule is a platform technology designed to work with the IOLs of today and to adapt to the technologies of tomorrow,” he adds. “We know that the lens capsule is an ideal space to safely house implants inside the eye. With the advancements in lens designs, drug delivery systems and electronics, we have created the platform for future intraocular innovation.”

HARMONI

ClarVista Medical, acquired by Alcon, developed the Harmoni modular IOL system for easy IOL exchange or upgrade. According to the company, the implant is a foldable acrylic dual IOL with hydrophobic base and optic components. The 13.0-mm diameter base has an open central body with an 8.5-mm diameter that serves as a scaffold for the optic. The final lens is formed by placing a 5.8-mm diameter optic within the body; both parts are designed to be placed within the capsular bag. To reduce capsular opacification, the base has a squared edge on the anterior and posterior sides. The large base size prevents central migration of proliferative lens epithelial cells therefore further decreasing opacification, according to the manufacturer.

Harmoni was evaluated in a prospective, multicenter clinical study of 114 subjects who had the study lens implanted in one eye and a standard monofocal in the other.³ At 3 months, subjects could undergo optic exchange if unsatisfied with monovision; 65 eyes had the optic exchanged, and 49 eyes did not. In the exchange cohort, the proportion of eyes with UDVA of ≥20/40 and ≥20/20 increased at 3 months after optic exchange vs preexchange levels by 23% (97% vs 74%) and 40% (49% vs 9%), respectively.

In all cohorts, ≥95% of subjects achieved UDVA of ≥20/40 after ≥12 months. Control and no exchange cohorts achieved CDVA of ≥20/40 by 3 months; 97% of eyes or greater had CDVA of ≥20/40 at 12 months after optic exchange. In the exchange cohort, the proportion of eyes with MRSE within ±0.50 D and ±1.00 D of target changed by 57% and 36%, respectively, from preexchange (20% and 59%, respectively) to 12 months postexchange (77% and 95%, respectively), reaching levels similar to control subjects (72% and 97%, respectively).

JUVENE

A two-piece modular IOL, Juvene (LensGen) consists of a base component with a fixed power optic that fills the capsular bag and a fluid-filled anterior lens that changes power with contraction and relaxation of the ciliary body. An advantage of the Juvene, according to the manufacturer, is that the lens fills the entire capsular bag, anterior to posterior, thereby allowing for more accurate prediction of the effective lens position. Further, this feature increases rotational stability, prevents capsular opacification and can potentially reduce vitreous movement, reducing the rate of posterior vitreous detachment and retinal tears or detachments.

The anterior lens power sits within the base component and is held in place by three tabs. The power of the anterior lens can be selected based on preoperative biometry, and a toric version can be implanted in patients with corneal astigmatism. The platform is similar to the Gemini in that it allows future technology to be placed.

In 12-month data published in 2022, 51 eyes were evaluated. The mean monocular logMAR CDVA, DCIVA and DCNVA were 0.01, 0.08 and 0.24, respectively.⁴ Defocus testing showed visual acuity >20/40 from approximately +1.00 through -2.00 D. Binocular implantation (n=16) provided superior performance over monocular implantation.

More recently, 36-month data found patients who were implanted monocularly had excellent distance, intermediate and near vision.⁵ Bilaterally implanted patients had excellent 20/20 distance, 20/25 intermediate and functional near at J3 or better. The range of vision, the quality of vision and the amplitude of accommodation were consistent from 1 to 2 to 3 years showing that the lens is maintaining its effect over time. The endothelial cell loss was comparable to what is seen in standard cataract surgery.

“The Juvene is a fluid filled modular IOL that provides excellent range of vision and quality of vision without many of the negative effects of diffractive optic IOLs,” says Sumit “Sam” Garg, MD, vice chair of clinical ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine. “The lOL has a long track record of safety and efficacy in human eyes. Three-year data shows the Juvene delivered contrast sensitivity comparable to a high-quality monofocal IOL (Tecnis, Johnson & Johnson Vision).”

OMNIVU

OmniVu (Atia Vision) is a modular shape-changing implant that the company says aims to deliver a premium solution that utilizes the natural accommodative mechanism of the eye to restore the full range of functional vision with minimal visual disturbances. It has two optical component. The accommodating base portion is in direct contact with the open capsular bag for efficient energy transfer from the ciliary muscle to its optic. The static front lens, which is exchangeable, controls the final refractive power of the IOL.

Upon accommodation, fluid moves from the periphery of the base to its center, changing the shape and increasing the power of the optic.

Three-month data on 13 subjects from an ongoing 12-month prospective, non-randomized, open-label clinical trial were recently presented.⁶ Stable refraction within ±0.5 D of plano was seen in 89% of subjects. The mean (±SD) monocular BCDVA was -0.02 (±0.07) logMAR (20/19), DCIVA was 0.01 (±0.10) logMAR (20/20), and DCNVA was 0.22 (±0.11) logMAR (20/33). The mean defocus curve showed visual acuity >20/32 over 0 D to -1.50 D. Subject nondirected symptom assessment reports revealed one subject with a positive dysphotopsia.

“The OmniVu lens system, by Atia Vision, is a truly novel solution for presbyopia in cataract patients,” says P. Dee G. Stephenson, MD, FACS, president and founder of Stephenson Eye Associates, Venice, Fla. “The modular lens design combines a high-quality monofocal, front optics and a fluid-filled shape-changing base. The lens base is designed to harness the natural accommodation mechanism of the eye and aims to deliver a full functional range of vision while preserving natural vision quality. The intentional design aims to overcome the challenges presented to first- and second-generation designs while offering a platform that is upgradeable.”

OPIRA

The sulcus-based, dynamic, shape-changing, accommodating Opira lens (ForSight Vision6) is made of silicone and allows direct contact with the ciliary body. Contractions pump fluid into the anterior optic, changing its shape and power. The lens spans from the ciliary body on one side to the ciliary body on the other side. The company says that the static posterior lens aspect could be used to correct regular astigmatism or for postoperative refractive adjustment.

A clinical study found the lens to be safe and stable, providing continuous monofocal quality vision across the functional near range.⁷ The data included 29 patients who were followed for 2 years after bilateral cataract surgery with implantation of a monofocal IOL in one eye and the Opira in the fellow eye.

Mean Snellen intermediate and near visual acuity in the Opira eyes was approximately 20/20 and 20/25, respectively, an outcome that was superior to the monofocal eyes. Consistent with the VA results, the monocular defocus curve from testing performed at 2 years showed the Opira had an extended range of focus across a large dioptric range.

CONCLUSION

In 2021, 29.7 million cataract surgeries were performed worldwide, including 4.7 million in the US alone, according to a recent report from ResearchAndMarkets.com .⁸ Premium IOL revenues expected to grow at a compound annual growth rate (CAGR) of 9.03% from $1.5 billion in 2021 to $2.5 billion in 2028, compared to a 6.2% CAGR revenue growth for the traditional IOL.

The outlook for premium IOL penetration is strong with the category leaning heavily on modular technology that allows for adapting lenses to patients’ changing visual needs. OM

REFERENCES

1. O’hEineachain R. IOL gives broader range of focus. www.escrs.org/eurotimes/iol-gives-broader-range-of-focus . Accessed May 15, 2023.
2. Quesada G. First-in-man experience with a device to maintain an open capsule long-term after cataract surgery. Presented at: the 2018 ASCRS meeting; April 16, 2018; Washington, DC.
3. Ang RET, Yoo P, Liu J. Visual outcomes after optic exchange of a modular intraocular lens. Multicenter Study. J Cataract Refract Surg. 2021;47:1441-1447.
4. Garg S, De Jesus MT, Fletcher LM, et al. Twelve-month clinical outcomes after implantation of a new, modular, anterior shape-changing fluid optic intraocular lens. J Cataract Refract Surg. 2022; 48:1134-1140.
5. Garg S. 36 Months Grail Study Results after Implantation of a New Modular, Shape-Changing, Fluid-Optic Intraocular Lens. Presented at ASCRS 2023; May 5-8, 2023; San Diego, CA.
6. Waring GW. Prospective, open-label, non-randomized, trial of a presbyopia-correcting, modular intraocular lens system for treatment of cataract. Presented at ASCRS 2023; May 6, 2023; San Diego, CA. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/90138 .
7. Naseri A. ASCRS Innovators General Session. Accommodating IOL. Presented at ASCRS 2021; July 23-27, 2021; Las Vegas, Nevada.
8. Global Intraocular Lens Market Outlook Report 2023-2028: Adoption & Penetration of Premium IOLs Gaining Momentum - ResearchAndMarkets.com . https://www.businesswire.com/news/home/20230421005192/en/Global-Intraocular-Lens-Market-Outlook-Report-2023-2028-Adoption-Penetration-of-Premium-IOLs-Gaining-Momentum---ResearchAndMarkets.com . Published April 21, 2023. Accessed May 28, 2023.