The FDA approves the only trifocal IOL for cataract surgery

Physicians have long awaited a trifocal intraocular lens (IOL) for cataract surgery patients, and Alcon has delivered with its PanOptix IOL.

Approved by the FDA in August 2019, the lens uses Enlighten Optical Technology, a design that optimizes intermediate vision without compromising near and distance vision. Available in spherical and toric designs, PanOptix is built on Alcon’s AcrySof IQ IOL platform that has been implanted in more than 120 million eyes globally.

The trifocal IOL can also reduce the effects of presbyopia by providing wearers with improved intermediate and near vision while maintaining comparable distance vision with a reduced need for eyeglasses, as compared with a monofocal IOL. Furthermore, the lens can be used to improve vision after cataract removal in people who have blurred vision due to corneal astigmatism.

Patient Outcomes

I was pleased to have the opportunity to participate in the FDA’s clinical trials for this lens, as trifocal IOLs dominate the European market and physicians there have praised the lens. More than 99% of PanOptix patients in the FDA study said they would choose the same lens again.¹ Since receiving FDA approval, 100 of my patients have had the surgery with similar results.

The FDA study involved a total of 243 patients: 129 patients (256 eyes) were implanted with the PanOptix lens (127 in both eyes and two patients in one eye); and the remaining 114 patients (225 eyes) were implanted with the control lens (111 in both eyes and three in one eye).

After six months of implantation, the average best-corrected distance with clear vision in one eye tested was approximately 20/20 for each group. For intermediate distance, vision in one eye with the PanOptix lens was approximately 20/25 compared with 20/40 for the control group. The vision for near-distance correction with the PanOptix lens was approximately 20/25, compared with 20/63 for the control group.

These results are extremely impressive—no IOL in the United States has demonstrated such good vision at all distances. There weren’t any safety concerns during the study.

Patient Qualifications

Ideal candidates have healthy eyes, or at minimum have no significant macular degeneration, glaucoma, or several irregular astigmatisms.

In my practice, the adoption rate for the PanOptix trifocal IOL is around 20%, and, in general, I have found that about 30% of patients choose an upgraded option.

The trifocal IOL reduces the need for eyeglasses after surgery, which is a main reason why patients choose the lens. Even if a patient doesn’t have pristine eyes, I still think it's worthwhile to have a cautious conversation about the lens’ benefits. Some patients are willing to accept a small risk, such as needing a lens exchange or decreased quality of vision, for increased flexibility of vision.

Most of the patients who don’t choose the lens only do so because it is cost-prohibitive, as insurance doesn’t cover it. Others are okay with wearing glasses.

When patients are indecisive, I tell them to weigh the pros and cons. It’s important for patients to consider if they have any frustrations with their current eyeglasses or contact lenses, such as experiencing dry eyes with contact lenses or having to fumble for glasses if they get up in the middle of the night. They need to determine whether the lens is worth the cost.

Although most of my patients get bilateral cataract surgery, some young patients may only require unilateral cataract surgery. In the latter cases, I determine whether it is feasible to implant the lens in only one eye. I base this on their other eye’s refraction and whether or not they would tolerate a contact lens or LASIK surgery in that eye, which would be necessary to avoid anisometropia.

Ease of Use

I have found that the PanOptix tri-focal lens is easy to place, and it goes in beautifully. The surgical procedure is similar to implanting any single-piece acrylic lens.

My biggest challenge is hitting a refractive target accurately to correct astigmatism. I use wavefront aberrometry on all patients who get this lens as it increases my chances of hitting the refractive target.

I conduct the same type of testing to determine a patient’s eligibility for this surgery as I do for other surgeries.

Indications and Side Effects

According to Alcon, some side effects can be associated with trifocal IOL models that may be worse than with a monofocal IOL due to the design of multifocal IOLs. These include visual disturbances such as glare, rings or starbursts around light sources, and reduced contrast sensitivity (a decrease in the ability to distinguish objects from the background, especially in dim lighting). These side effects may make it more difficult to see while driving at night or completing tasks in low lighting conditions—such as at night, in fog, or in a dimly lit room—after surgery as compared with before surgery.

Although my patients seem to tolerate it well, the most significant side effects are dysphotopsias. Patients complain less about glare and halos early on—which the FDA’s study corroborates. I tell patients to expect halos and glare, which can make it difficult to read small print in dimly lit areas. Most people learn to ignore them, because it is nonuseful information to the brain—much like eyeglass wearers ignore their frames. I tell patients that over time they will pay less attention to these diversions. I have not had to remove the lens from any patient due to complaints.

Furthermore, a toric IOL corrects astigmatism only when it is placed in the correct position in the eye. There is a possibility that the toric IOL could be placed incorrectly or could move within the eye. If the toric lens is not positioned correctly following surgery, the change in astigmatism correction by the IOL, along with any necessary correction with glasses, may cause visual distortions. If the lens rotates in the eye, the patient may need additional surgery to reposition or replace the lens.

I remain impressed with the lens’ rotational stability and its toric component. The Alcon platform has proven to be the most stable in the eye, which gives me confidence that the lens will stay where it was intended and correct the most amount of astigmatism.

There is also a chance that patients may still need glasses for distance, intermediate, and/or near vision. They only get the full benefit of the trifocal IOL when it’s placed in both eyes.

Shaping The Future

Although the previous generation of multifocals was good, no single lens could provide clear vision for distance, intermediate, and near viewing. So, we would combine a low-powered multifocal with a high-powered multifocal. Although that approach worked pretty well, if one lens can do it all, it's a win-win all the way around for me.

I consider the PanOptix IOL to be the first of the next-generation lenses. It makes sense to have both eyes see clearly in the distance, intermediate, and near. It is quickly becoming my first choice for multifocal lenses. ■

Reference

1. Alcon Laboratories, Inc. AcrySof^® IQ PanOptix^® Trifocal Intraocular Lens (Model TFNT00) and AcrySof^® IQ PanOptix^® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50, TFNT60). US Food & Drug Administration. Available at: https://www.fda.gov/medical-devices/recently-approved-devices/alcon-laboratories-inc-acrysofr-iq-panoptixr-trifocal-intraocular-lens-model-tfnt00-and-acrysofr-iq ; last accessed Dec. 13, 2019.