Presbyopia-correcting IOLs present opportunities for patients, surgeons
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The first FDA-approved presbyopia-correcting IOL entered the U.S. market in 1997 when the Allergan Medical Optics Array IOL was launched.
Starting in 1980, 3M Vison Care pioneered the application of diffractive optics to presbyopia-correcting IOLs. 3M Vision Care was divested to Alcon in the early 1990s, and further optical development resulted in the Alcon ReSTOR diffractive IOL family, which has today further evolved into the market-leading PanOptix trifocal presbyopia-correcting IOL. Advanced Medical Optics later acquired diffractive presbyopia-correcting IOL technology from Pharmacia, and today, after acquisition of Abbott Medical Optics by Johnson & Johnson Vision, the J&J Vision Synergy trifocal IOL is its lead presbyopia-correcting IOL.
Over a 25-year period, the leading presbyopia-correcting IOLs in the U.S. market have gravitated from refractive optics to primarily diffractive optics. More recently, a second class of presbyopia-correcting IOLs has evolved to provide excellent distance and intermediate along with useful near vision — extended depth of focus (EDOF) IOLs. One IOL, the Bausch + Lomb Crystalens, has achieved approval and is labeled as an accommodating presbyopia-correcting IOL, but many surgeons today would place it in the EDOF category. The Crystalens is a purely refractive optic, as is the newly approved Alcon Vivity presbyopia-correcting IOL. To round out the U.S. offering, we have the hyper-aspheric Johnson & Johnson Vision Eyhance and the RxSight Light Adjustable Lens refractive optic monofocal IOLs, which provide good quality distance vision with some enhanced intermediate and near vision, but less than the amount required to be labeled as an EDOF IOL. Coming soon is the AcuFocus IC-8 IOL, which utilizes small-aperture optics to achieve EDOF status. This lens seems especially well suited for the patient with a complex cornea and regular or irregular astigmatism.
I have been involved in the evolution of presbyopia-correcting IOLs since 1980 when I joined 3M Vision Care as its chief medical officer and we began investigating the application of diffractive optics to IOLs. I have consulted widely in this field for 40 years. Here are a few personal thoughts.
Adoption of presbyopia-correcting IOLs has been slower than expected in the U.S. and even slower globally. The 3M diffractive multifocal IOL was launched outside the U.S. in 1985 and 1986, and 35 years later, less than 5% of IOLs implanted worldwide are presbyopia-correcting IOLs. In the U.S., with the largest presbyopia-correcting IOL adoption rate in the world, we were at just more than 9% market penetration in 2021, according to Market Scope.
Several studies confirm that the patient’s refractive outcome is the key metric when measuring patient satisfaction after performing refractive cataract surgery, whether for astigmatism treatment, presbyopia management or both. Both spherical equivalent and residual astigmatism must be within 0.5 D of target and preferably within 0.25 D of target for high patient satisfaction. A meta-analysis of outcomes with presbyopia-correcting IOLs performed at Optical Express by Steve Schallhorn, MD, suggests the preferred target for a presbyopia-correcting IOL in the distance eye is slightly hyperopic rather than slightly myopic. In this same study, mild with-the-rule astigmatism was also the patient-preferred outcome. These data support the fact that a highly skilled surgeon with the training and equipment to enhance refractive outcomes after surgery is required to build a successful refractive cataract surgery practice. A quality refractive outcome is the dominant factor in patient satisfaction, and patient satisfaction is the dominant factor in practice growth. I believe these exacting patient refractive outcome requirements are a challenge for many ophthalmic surgeons and represent the greatest barrier to presbyopia-correcting IOL adoption.
No more than 30% of cataract surgeons in the U.S. are comfortable with performing a refractive outcome enhancement using incisional or laser refractive corneal surgery. I hope growth in the ability to adjust IOL power postoperatively, as pioneered by the Light Adjustable Lens, will become more prevalent, as this approach will be more readily adopted by many cataract surgeons. IOL designs such as the IC-8 Apthera small-aperture IOL that mask up to 1.5 D of astigmatism will also help.
Refractive cataract surgery remains an outstanding opportunity for every cataract surgeon and for the industry that supports us. Market Scope data suggest that approximately 5 million refractive cataract surgeries were performed globally in 2021. These refractive cataract surgeries generated just more than $12 billion in incremental revenues to the operating surgeons and more than $2 billion for industry. Many believe a reasonable target for refractive cataract surgery in 2030 is 30% of U.S. cataract cases. If this penetration is reached, the economic impact to our profession will be significant.
Cataract surgery remains the most common surgical procedure performed by the comprehensive ophthalmologist. Growth in refractive cataract surgery remains the top opportunity to enhance an ophthalmology practice’s financial viability and sustainability. The other two (outside of adding medical retina) are increasing the use of MIGS in combination with cataract surgery when indicated and enhancing the volume of patients seen in the clinic. These vital few opportunities are worth careful consideration by all of us as we face an ever more challenging external environment.
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