Technology, education key to changing presbyopia treatment paradigm
Few conditions impact as many people worldwide as presbyopia. Recent estimates have placed the prevalence of presbyopia in the 2 billion range.
“Presbyopia is a near ubiquitous disorder that nearly all living humans go through,” Healio | OSN Presbyopia Section Editor George O. Waring IV, MD, FACS, said. “There are more than 2 billion presbyopes worldwide, each with two eyes. That is more than 4 billion presbyopic eyes that we could help.”
Source: Waring Vision Institute
Waring said that in many parts of the world, people have limited access to vision aids and struggle to function in their daily activities and work.
“There’s even a global health and productivity aspect to this,” he said. “The other aspect is safety. The typical vision aids for presbyopia are bifocals and trifocals. In the United States, falls kill more people than breast cancer and prostate cancer, and one-third of falls are related to multifocal glasses. This is not just about convenience.”
Waring said, “There is an opportunity before us, a dogma shift,” surrounding which patients are candidates for presbyopia correction. Thanks to recent advances in technology and new options on the horizon, that shift may be coming.
Evolution of presbyopia correction
Healio | OSN Presbyopia Board Member Daniel H. Chang, MD, said that because the development of presbyopia correction arose in a similar fashion as refractive surgery, many surgeons see its importance as similarly optional.
“It’s been viewed as something that is merely a lifestyle benefit for the patient,” he said. “Since presbyopia correction is frequently considered a ‘premium’ option, physicians may focus more on the convenience and financial benefits than on the medical and safety benefits of this technology. Therefore, in patients with preexisting ocular pathology, surgeons may worry that the appropriateness of their use of a presbyopia-correcting lens may be questioned.”
However, the safety benefit of a solution that goes beyond multifocal glasses should outweigh those concerns, Chang said. A large part of changing this perception falls on physicians to educate their patients and introduce them to the technology, he said.
“Everybody has presbyopia, and everyone who gets a monofocal lens has presbyopia,” Chang said. “So, everybody should, at least on some level, be considered a candidate, and then you start ruling them out. It’s about meeting the patient’s expectations. If I can provide the patient the vision that they’re expecting to get, they’re going to be happy. If they have a fantastic eye, I should be able to hit that outcome. If they have a bad eye, I can only do so much regardless of what lens I use. It’s all about setting expectations.”
New technology means that addressing presbyopia has become more sophisticated. Waring said there have been proposals to establish a new subsector of refractive surgery to group all the different procedures that surgeons may use.
“It’s relative to all the different types of glaucoma procedures that historically have had a fellowship related to the surgical or intervention of glaucoma,” he said. “We think about presbyopia correction somewhat in the same way because there are so many different ways that we can help people with presbyopia.”
Types of presbyopes
While there are different approaches to address presbyopia, Robert E. Ang, MD, said it is important to think about the types of patients with presbyopia. Grouping patients can help determine the best avenue for correction.
First is the emmetropic presbyope who does not need any correction for distance but has lost near vision, second is the hyperopic presbyope who needs glasses for distance and near to function, and third is the myopic presbyope who needs glasses for distance but has near vision without glasses.
“These groups have different trigger points of when to seek a solution,” he said. “Myopes in general have been disabled for distance for a long time, since they were young. The presbyopia is an additional disability or inability, which they may not realize. I see these patients when they want a solution for their distance vision, but they might not realize that if I solve their distance, I will convert them to a presbyope, and their other disability will come on. Hyperopes and emmetropes come in because they need a solution for reading, and their reason for coming in is really presbyopia.”
Ang said there are solutions for patients with myopia, such as LASIK or an ICL (STAAR Surgical), but surgeons need to educate them on the trade-off that comes with those solutions.
“If they come in at 45 years old, we have to tailor the surgical solutions to compromise some distance vision so that they retain their near vision,” he said. “We have to tell them that we can improve their distance, but they will lose some near. They have to sacrifice some far to retain their reading. That’s where a combination of gain and sacrifice comes in.”
Conversations with patients with hyperopia have a similar component of sacrifice, Ang said. These patients have acceptable distance vision, but they may need to sacrifice to obtain the near vision they desire.
Ang said patients with emmetropic presbyopia can be the trickiest ones to manage because they have no experience with vision correction via glasses or contact lenses.
“Our older solutions, like micro-monovision, all tend to sacrifice one eye for near and leave the other for far,” he said. “Or they have the newer solutions that are designed to improve near vision without sacrificing distance. The tricky part is your practice. As an ophthalmologist now or 5 years from now, I must have a solution for all three of these buckets or else I am forcing them into what I have on offer, and they might not be happy.”
In addition to refractive status, Waring said there are other factors that go into the decision-making process, including stage of lens dysfunction and eye health. Historically, surgeons may have recommended a corneal-based procedure for earlier forms of presbyopia and moved to a lens-based solution for second stage lens dysfunction.
“What we realized is that 5 or 10 years further down the road many of the patients who we performed a blended vision approach in their first stage of lens dysfunction aged through that solution into another stage of eye maturity,” he said. “Now, we’re faced with working around what is often a hyperprolate cornea, which may affect some of our IOL choices. We have evolved over the last decade toward more custom lens replacement as our primary approach for presbyopia for most cases to preserve binocularity, which is where we typically have better uncorrected visual acuity at all distances with improved contrast sensitivity. This also prevents the aging changes that are all but guaranteed and obviates the need for a cataract procedure in the future.”
Waring said lens replacement is growing in popularity as the newest full vision range lenses have been updated with more favorable dysphotopsia profiles and less impact on contrast sensitivity.
“This is all done with a careful risk-benefit analysis, proper informed consent, and counseling on potential side effects and potential need for future treatment such as YAG capsulotomy, laser vision correction enhancement or a refractive vitrectomy for cloudy vitreous syndrome,” Waring said. “All of these can be important over the lifespan of the patient and are additional opportunities to help a patient see well over their lifetime.”
Ang said the new frontier for presbyopia is in patients with emmetropic presbyopia.
“There’s no treatment that specifically addresses emmetropic presbyopia,” he said. “Even though the first eye drop, Vuity (pilocarpine hydrochloride ophthalmic solution 1.25%, AbbVie), was not received well, multiple companies are trailing and hoping to get their eye drops approved. There are coming products in the eye drop space, but there is a void. There’s a big group of patients waiting for a jackpot solution, and that’s the emmetropic presbyope group.”
The newest eye drop solution is Qlosi (pilocarpine hydrochloride ophthalmic solution 0.4%, Orasis Pharmaceuticals).
“Qlosi has the lowest effective concentration of pilocarpine approved and is preservative free, and only one drop needs to be instilled in each eye daily,” Healio | OSN Board Member Mitchell A. Jackson, MD, said. “FDA approval occurred in the fourth quarter of 2023, and the commercial release is expected early this year. In its FDA study, 78% of participants maintained a distance corrected near visual acuity of 20/40 or better at 8 hours. Of the adverse events, the main one was headache at 6.8% vs. 0.7% in the control group.”
Laser scleral microporation
Presbyopia correction has been available for years, but the methods usually come with a trade-off. One method in the pipeline, laser scleral microporation (LSM, Ace Vision Group), could offer surgeons an option that addresses the root cause of presbyopia without the traditional trade-offs.
Ang said the biggest driver of presbyopia is aging, not refractive issues.
“Aging is when parts of your eye grow old and function less,” he said. “Specifically, new studies are showing that the sclera undergoes stiffening as you age. The muscles and zonules that control the lens of the eye in autofocus are attached under the sclera. When you are young, this wall is soft and moves with the lens. When you grow old, if this becomes stiffer, then the muscles cannot be as flexible.”
Ang said LSM softens the scleral wall where the muscles are attached, making it more pliable.
“When the muscle pulls, it retains the ability to be flexible because that’s what you lost,” he said. “We want to loosen this muscle so that the eye can retain its natural ability to focus. That’s the beauty of it. It’s the natural ability without changing anything in the eye. It’s like a potion to stay young, but it’s a laser.”
Jackson said Ace Vision Group is starting trials this year and is seeking 510(k) clearance.
“It is an in-office bilateral procedure that takes less than 10 minutes, similar to LASIK, and can even be done remotely with a technician on site to run the laser,” he said. “The newest commercial version of this technology will allow precise placement of the scleral Er:YAG micropores to avoid subconjunctival hemorrhages and for enhancements to keep up with the aging process until a patient develops cataracts. The current laser will also provide real-time OCT imaging to get exact scleral depth because various cultures differ significantly in scleral thickness, and 85% to 90% pore depth is needed to gain the desired effect.”
Education
One of the biggest barriers to better and more widespread presbyopia correction is education, according to Chang. He said that education needs to start with physicians and medical societies.
“It begins with understanding what the factors and issues are, how they apply and how we can apply them to patients,” he said. “The ESCRS Functional Vision Working Group is working to define some of these terms but also to make the concepts more concrete. ... Hopefully, introducing that to a broader audience can help us consistently talk about these lenses and better understand how to address issues in difficult cases.”
Chang said there has been some disagreement on what to even call presbyopia-correcting lenses. Some have suggested terms such as simultaneous vision IOLs, but that may confuse patients, he said.
“Imagine me talking to a patient and saying, ‘I’m going to put a simultaneous vision intraocular lens in you,’” he said. “They would have no idea what I was talking about.”
Chang prefers the term “range of vision lens” because it is simpler and conveys what the lens does in a way patients can understand. Issues with terminology go beyond technology, however. The terms for what people experience visually can also be confusing and overly complicated, he said.
“We get scientists who want to be very critical, but we need very practical,” he said. “When I talk to a patient or when we go on the podium at conferences, people say words like starburst, but it’s a hard word to say. Everybody says glare and halos. Johnson & Johnson started talking about spiderwebs, which I think is easier to say and understandable.”
Chang said the ESCRS working group has just started to talk about these issues, and there is a lot of work still to be done when it comes to naming conventions and ways to improve education in the presbyopia space. However, he is optimistic because groups are starting to address these issues.
“I know various other groups have talked about this on different levels. No one ever seems to agree because we all have our own little interests,” he said. “ESCRS is not a standards organization, but we’re based on education, advocate for surgeons and find ways to improve our field. The more confusion, the more contracted the field will be. The more consistency and agreement we have, the more the field can grow.”
- References:
- Fricke TR, et al. Ophthalmology. 2018;doi:10.1016/j.ophtha.2018.04.013.
- Orasis Pharmaceuticals announces FDA approval of Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia. https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia/. Published Oct. 18, 2023. Accessed Jan. 8, 2025.
- For more information:
- Robert E. Ang, MD, of Asian Eye Institute in Makati, Philippines, can be reached at angbobby@hotmail.com.
- Daniel H. Chang, MD, of Empire Eye & Laser Center in Bakersfield, California, can be reached at dchang@empireeyeandlaser.com.
- Mitchell A. Jackson, MD, of Jacksoneye in Lake Villa, Illinois, can be reached at mjlaserdoc@msn.com.
- George O. Waring IV, MD, FACS, of Waring Vision Institute in Mount Pleasant, South Carolina, can be reached at gwaring@waringvision.com.
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