New IOLS in the US and Beyond

New lenses and materials are debuting across the globe. Here are some highlights from recent additions to the market.

By Lisa B. Samalonis, Contributing Editor

New intraocular lenses, approved for use here and abroad, provide improved visual quality for patients across an increasing range of vision — and also for patients with astigmatism. What follows are research updates on some of the latest technologies.

Small-aperture IOL

Earlier this fall, AcuFocus Inc.’s extended depth of focus IOL, the IC-8 small aperture IOL, received CE Mark approval in Europe (Figure 1). The lens is designed to improve depth of focus, providing the patient good distance, intermediate and near vision. The IC-8 builds on the company’s small aperture platform, the KAMRA inlay. Research with the KAMRA inlay demonstrates that the small-aperture effect provides improved near vision that is predictable and reliable while also maintaining distance vision.¹ According to AcuFocus, the IOL is designed to address common visual limitations (incomplete range of vision, disabling visual quality degradation from induced glare and halo, and loss of binocular contrast) and return high quality, continuous functional vision.

Figure 1: The Acufocus IC-8 small aperture IOL is designed to provide excellent visual quality across a broad range of vision for presbyopic patients with cataracts.
COURTESY: ROBERT ANG, MD

Early results from monocular implantation of a small aperture IOL show improved range of vision after cataract extraction of a mean J1 at near, and 20/20 at both intermediate and distance at 12 months. Patients report a few symptoms, which is comparable between IC-8 and fellow monofocal IOL implanted eyes.¹

This new IOL is a single-piece, hydrophobic acrylic lens. The surgeon implants it monocularly in the non-dominant eye, thereby allowing more patients to benefit from small aperture optics. As for specs, the opaque mask is 5 microns thick; has 3,200 microperforations; is 3.23 mm in diameter; and has a 1.36-mm aperture. It is made from polyvinylidene fluoride and nanoparticles of carbon.

“The platform is a hydrophilic acrylic similar to the other lenses in use today. It is foldable, so surgical technique and familiarity with the material make it easy for surgeons to adapt,” says Robert Edward Ang, MD, with the Asian Eye Institute in Makati City, Philippines.

“Because of the pinhole effect, near vision is improved without sacrifice of distance vision and induction of unwanted glare,” he explains. “There is a mild decrease in contrast, but not as much as a multifocal lens. Also, because of the pinhole effect, this lens is more forgiving in terms of tolerance to residual refractive error and astigmatism.”

Dr. Ang has performed 15 surgeries to date, with nine eyes with one-year follow-up. The patients’ refractive outcome at one year is -0.14 D spherical equivalent. The mean uncorrected distance vision is 20/25, intermediate is 20/20 and near is J2. “Patients are very satisfied with their vision with almost no glare and minimal halos,” he says. “Five of the patients had previous cataract surgery with monofocal IOL implanted in the fellow eye and they report good overall distance, intermediate and near vision without the need for spectacles, no problems with depth perception, no glare and slight halos at night.”

The company reports that it has designed a tight roll-out of the product in Europe. AcuFocus has not yet applied for a premarket approval application in the United States, according to the FDA website.

Extended range of vision IOL

Positive data from numerous recent clinical studies on the Tecnis Symfony Extended Range of Vision IOL (Figure 2) showed that after implantation, cataract patients experienced a full range of continuous, high-quality vision after surgery, with a rate of halo and glare comparable to a standard monofocal lens.²

Figure 2: The Tecnis Symfony IOL’s diffractive echelette design elongates the eye’s focus and results in a continuous, extended range of vision.
COURTESY: ABBOTT MEDICAL OPTICS

Abbott received the European CE Mark and launched the Tecnis Symfony IOL there in May 2014 for the treatment of people with cataracts who may also have presbyopia. The IOL’s diffractive echelette design elongates the eye’s focus and results in a continuous, extended range of vision, Abbott says.³ Additionally, the design does not split light, resulting in reduced glare and halos.

According to Gerd U. Auffarth, MD, professor and chairman, department of ophthalmology, Ruprecht-Karls University of Heidelberg, Germany, the study² shows the Tecnis Symfony IOL offers a substantial improvement in the range of vision for patients, while still minimizing undesired halos or glare. “There was a high degree of patient satisfaction and spectacle independence in everyday life. People found it easy to drive during the day or night, watch television or use a computer. These types of results can make a huge difference for people and their everyday quality of life,” he explains, adding that there were no unexpected medical findings or device-related adverse events.

The company is conducting a three-month study of 150 people, with 111 enrolled at 14 sites across Europe. One hundred and six people have undergone cataract surgery and received the new IOL (Model ZXR00) in both eyes. Data from 82 people examined one month following surgery showed that 99% of patients had binocular uncorrected vision of 20/40 or better at far and intermediate distances. Eighty-one percent achieved 20/20 or better for distance visual acuity and 65% reached 20/20 at intermediate visual acuity. Eighty-eight percent of patients had binocular uncorrected vision of 20/40 at near distances.

In addition, subjects maintained functional vision (20/40) throughout the range from distance to near vision (through 2.0 D of defocus on average).²

Post-implantation, 72% of people reported never or rarely needing eyeglasses. Also, patients could perform daily activities without eyeglasses at far distance (98%), at intermediate distance (96%), and at near distance (73%). Abbott is also conducting an ongoing post-market observational study with more than 400 people across Europe, including the United Kingdom, France, Germany and Spain. The lens is currently not approved in the United States.

“Abbott is currently enrolling patients for clinical studies in the United States so that the product can be submitted for FDA approval,” says Krysta Pellegrino, Abbott Medical Optics, director of public affairs.

Multifocal toric

Alcon Laboratories Inc.’s AcrySof IQ ReSTOR Multifocal Toric Posterior Chamber Intraocular Lens combines the optical properties of a +3D multifocal IOL (MFIOL) with the optical properties of a toric IOL. The IOL’s proposed indication is for primary implantation in adult patients for visual correction of aphakia and pre-existing astigmatism, secondary to removal of a cataractous lens. The lens is designed for patients who might or might not have presbyopia, but do want near, intermediate and distance vision, the reduction of residual refractive cylinder and increased spectacle independence.

Bret L. Fisher, MD, medical director, Eye Center of North Florida in Panama City, participated in the ReSTOR Toric US registration study and Alcon’s blue light filtering post-market study. “The overall benefit of the … Toric is that it combines the wide range of functional uncorrected vision of the current ReSTOR IOL with stable, predictable, effective correction of astigmatism. This allows surgeons to offer the benefits of multifocality to a wider range of patients.”

The lens uses the performance and refractive stability of the Acrysof acrylic one-piece platform and the apodized, diffractive aspheric optics of the latest generation of the ReSTOR 3.0 add multifocal lens.

“Blue light filtration also contributes to the excellent visual performance of the lens, while the addition of toricity to the IOL allows the lens to be used to correct a substantial amount of corneal astigmatism,” Dr. Fisher explains. “This new lens better addresses the needs of patients with astigmatism by allowing them to have the option of achieving high rates of spectacle independence with excellent uncorrected distance, near and intermediate vision.”

Rosa Braga-Mele, MD, MEd, FRCSC, professor of ophthalmology, University of Toronto agrees that the combined platform of a diffractive MFIOL and a toric component allows a larger range of patients who want their vision, both near and far, corrected through cataract presbyopia treatment to take place. She appreciates the ReSTOR Toric IOL’s wide availability, from t2 to t6, that allows her to treat corneal astigmatism tfrom 0.75 D to about 2 D “in a very precise manner.”

“This has allowed me to treat more patients wishing to have an MFIOL, as I know that the accuracy and stability of the toric component of this lens will allow more stable and predictable visual outcomes that are needed to optimize the MFIOL component and minimize any visual side-effects,” Dr. Braga-Mele says. “Due to the design of the Acrysof platform there is tremendous confidence in the stability of this IOL both for toric alignment and for IOL centration.”

Dr. Braga-Mele notes that some of her happiest cataract patients are the ReSTOR Toric IOL recipients, due to the clear distance vision the lens delivers and the correction of their astigmatism. Another significant benefit: They can read most type without resorting to glasses.

The IOL broadens the choices for patients with astigmatism. Dr. Braga-Mele has implanted 100s of these toric IOLs. “It has a wide range of toric IOL choices that treats a wide range of corneal astigmatism. Also, due to the design of the platform and the IOL material with its fibronectin component, it offers a tremendous amount of predictability and stability with great rotational alignment,” she says.

As for the IOL’s prospective approval for the US market, Alcon reports it is working with the FDA as the company finalizes its review, and hopes to have a decision in January. The agency’s Advisory Committee recommended approval for the lens at its November 14 meeting. It reviewed data from a clinical study that involved more than 570 patients.

Toric IOL with Expanded Power

Bausch + Lomb launched an expanded power range of Trulign Toric IOL at the American Academy of Ophthalmology meeting in October (Figure 3). The lens, available in mid-range powers between 17.0 D and 25.0 D, now comes in 10.0 D to 16.5 D (in half diopter steps). Additional powers, from 25.5 D to 33.0 D, are expected later this year.

Figure 3: The Trulign Toric IOL is now available in an expanded power range from 10.0 to 16.5 (in half diopter steps).
COURTESY: BAUSCH + LOMB

“The release of lower power Trulign IOLs allows surgeons to offer toric treatment with an expanded range of vision to a larger percentage of our patient population who are astigmatic,” says Kurt Weir, MD, in practice in Oklahoma City, OK. Many high myopes have significant amounts of astigmatism, he notes, and before these lower power IOLs were released, the only option surgeons had for these patients was a single-focus monofocal toric IOL.

“The Trulign’s greatest benefit to our patients is its ability to not only correct astigmatism, but to provide expanded range of vision due to its hinged flexible design. The aspheric optic provides high quality distance vision and its expanded range allows intermediate and some near function as well. The four-point haptic design of the IOL and its vaulted position make this the most stable toric design with very high rotational stability,” Dr. Weir says.

The ability of the Trulign Toric IOL to reduce or eliminate preoperative astigmatism is significant, concurs Robert Weinstock, MD. “My patients are enjoying a reduced dependency on glasses for many activities with their Trulign implant following cataract surgery, and it is helping to significantly enhance their quality of life,” he says.

With new IOLs and expanded ranges of power both domestically and abroad, surgeons now have more IOL options to customize treatment for their individual patients. OM

REFERENCES