Refractive: Hot topics in ophthalmology
December 2022

by Ellen Stodola
Editorial Co-Director

The EVO Visian ICL (STAAR Surgical) was recently approved for the treatment of myopia and astigmatism, with updates to the previous ICL technology. Several physicians discussed the technology with EyeWorld: what’s new, how they’re using the product, and results they’ve seen so far.

Evan Schoenberg, MD, described himself as an “enthusiastic fan” of the EVO ICL. He’s been using it since its FDA approval in March 2022. “I stopped doing the previous version of the ICL about 3 months ahead of the FDA approval when it was clear it was coming down the pipeline because I thought it would be a better solution,” he said. 

“I start talking about the ICL with patients [with myopia of] –7 or above who present for refractive surgery,” he said. “I consider it in lower myopes in certain situations—patients with lower degrees of myopia but who have some cornea contraindications to LASIK/PRK or who are interested in the element of reversibility of the technology.” He added that if a –5 to –6 D patient is approaching cataract age but not quite ready for cataract surgery, he will use it as a bridge until they have surgery. You can do an ICL now and a lens procedure in 5–10 years.

Bennett Walton, MD, has moved all ICLs to the new EVO ICL version. “I expect to be doing more EVO ICL procedures than I did with the former ICL model,” he said. “The optics remain great, but it’s easier on patients because the EVO ICL does not require a peripheral iridotomy (PI) due to its aqueous flow ports.”

The EVO ICL and EVO+ ICL are indicated for patients with myopia or myopia with astigmatism who are 21 years or older and have a healthy corneal endothelium, with an open angle and a 3 mm aqueous depth (defined as endothelium to anterior lens capsule centrally). It’s approved for myopia correction from –3 D to –15 D and myopia reduction up to –20 D, with the toric version approved for up to 4 D of astigmatism in the spectacle plane.

The EVO+ ICL has a larger optical zone than the EVO ICL, Dr. Walton said. In the refractive surgery world, larger optical zones provide better quality of vision. But just as a larger optical zone requires more tissue removal in LASIK, it requires the optical portion of the ICL to extend further. “Therefore, for lower powers of myopia, up to –14 D, the optical zone is increased to as much as 6.1 mm for the EVO+ ICL. For the higher powers, an EVO ICL is used,” Dr. Walton said. “The highest spherical equivalent power available in the U.S. is a –16 D lens, and many ICL surgeons use the –16 D lens to debulk the majority of high myopia. Then LASIK for the residual can be performed.”

In his practice, there is an overlap in LASIK and EVO ICL candidacy. Between 7–9 D of myopia is where the ICL might be favored over LASIK. Once a patient is significantly higher than that, the ICL holds a strong advantage, Dr. Walton said.

Neda Shamie, MD, said that the classic ICL candidate is someone with high myopic correction who wouldn’t otherwise be a candidate for LASIK/PRK. “In our practice, even if a patient has good corneal thickness, if their correction is more than –8.5, we don’t think that the quality of vision that they can gain from corneal-based refractive surgery is good enough; when you change the contour of the cornea to correct –8.5 and more, the contrast and color perception are affected, quality of vision is affected, and glare and halos at night potentially become visually significant,” she said. 

Dr. Shamie has implanted the EVO ICL for lower corrections if the patient has dry eye that does not respond to conservative measures. She has also had a number of patients who are excellent candidates for LASIK, but they don’t like that LASIK involves tissue removal and don’t like that it’s not reversible, so they come in specifically asking for the EVO ICL.

What’s different now?

Blake Williamson, MD, has been thrilled with the launch of the EVO ICL and said his practice was involved in the early stages of the ICL when it came out almost 20 years ago. But it was always challenging because you have to do PIs, he said. PIs are no longer needed with the EVO ICL. Dr. Williamson said his practice switched to doing ICLs on the same day bilaterally. These patients, at the 4-hour pressure check, are routinely better than 20/20, he said. 

With LASIK, there might be flap edema and vision might not be totally crisp right away, Dr. Williamson said. With the ICL, there is no pain the first day, and quality of vision is spectacular, he said. “You’re not altering the shape of the cornea, it’s just enhancing the vision patients already have.” Because of that, Dr. Williamson will offer the EVO ICL in situations he otherwise reserved for LASIK. “It used to be my cutoff was –8.75 to –9 to say we can’t get it all with LASIK,” he said. “I’ve come down to –7, so if a patient is –7.5 and a good candidate for the EVO ICL and has the correct anterior chamber depth, I’m talking to them about the EVO ICL because that’s what I would want in my eye.” He recently did a –3 patient as well; the patient had corneas too thin even for PRK.

As far as the EVO ICL eliminating the need for PIs, Dr. Schoenberg said there is a small hole in the center of the lens, which prevents the possibility of pupillary block. “That sounds like a small thing, but it’s a big deal,” Dr. Schoenberg said. It simplifies the procedure, eliminates one possible source of risk perioperatively, and eliminates long-term risk of the PI occluding, leading to pupillary block. Additionally, data out of Europe demonstrated that the addition of this flow port in the middle of the ICL reduced the rate of some isolated complications. Cataract formation dropped to almost zero. It’s also safer to do a lower vault, which reduces the risk of an angle closure, Dr. Schoenberg said.

However, this does present a potential complication, as the small hole in the center of the lens could be a source of glare. “I treat it as a definitive source of glare for patients,” Dr. Schoenberg said. “I tell patients ‘You’re going to see a circular glow on day 1 and probably for a couple of weeks.’” In most patients, it fades and they stop noticing it, Dr. Schoenberg explained. There is the possibility that patient may not adapt to the glare and would have the visual disturbance long term, but if you were to remove the lens, the glare goes away. 

Roger Zaldivar, MD, said that this is a huge step forward for the ICL safety profile because it avoids the most common complications of anterior subcapsular cataract formation, pigment dispersion, and pupillary block. 

“Perhaps the most important fact to emphasize in the EVO ICL design is the zero cataract formation experienced during the last 10 years,” Dr. Zaldivar said. Patients’ surgical experience has improved remarkably, too, he said.

He also noted that the hole in the lens might cause some minor glare. “We’ve found that 30% of patients experience moderate glare at night in the first 3 months, and it improves considerably in the following months,” he said. 

Dr. Shamie said that the EVO ICL is easy to recommend to patients and much easier to add to the surgical armamentarium if you are a surgeon who has not done ICLs before. In the previous generation of ICLs, the PI and its associated comorbidities were limiting factors, Dr. Shamie said, and you couldn’t tell a patient that this was minimally invasive. It was also previously more labor intensive, as patients had to come in for extra visits and had to potentially be put on steroid drops ahead of time to treat PI-related inflammation.

Proceed with caution

Dr. Zaldivar cautioned against using the EVO ICL in patients with shallow anterior chambers (less than 2.8 mm) or iridocorneal angles of less than 25/30 degrees. “It is slightly more complicated in these because you have to consider the power of the lens and lens rise,” he said. “High power ICLs get thicker in the periphery and tend to need a bigger angle. To facilitate this surgeon decision-making process, we have created a machine-learning solution that will be available soon.”

Dr. Schoenberg also noted the importance of needing proper anatomy for the EVO ICL. It requires open angles and a good enough chamber depth, so the lens doesn’t crowd the angle. You also want to make sure the patient has a healthy endothelium. Even with the larger optic/optical zone of the new ICL, Dr. Schoenberg noted the possibility of glare increases if the pupil dilates beyond the edges of the lens optic.

Dr. Walton said that a patient with iris damage, zonule damage due to trauma, or moderate/severe glaucoma would not be a good candidate for the EVO ICL. Dr. Walton said that for sizing, ultrasound techniques for direct sulcus measurement are becoming increasingly popular.

Dr. Williamson mentioned a few scenarios where he might be hesitant to use the EVO ICL. Again, small anterior chambers are one, with 2.79 mm being his cutoff. For patients close to age 45, you might want to think about a different option because the lens is undergoing some changes. He stressed that it’s important to make sure patients understand how vision changes over a lifetime. Physicians also might want to think twice before using the EVO ICL in patients who have glaucoma, he said, explaining that while pressure spikes aren’t common, they’re possible. 

Dr. Williamson said UBM scanning would be helpful not only for sizing but to identify any irregular anatomy in the sulcus that could affect the ICL placement. If a patient has a ciliary body cyst, it could disrupt proper ICL positioning. He added that you don’t have a to buy an expensive UBM; you can get started with biometry and manual calipers.

Transitioning to the new ICL

The EVO ICL is a minimally invasive procedure done through a small clear corneal incision and takes less than 10 minutes per eye, Dr. Shamie said. It can be done at an in-office surgery suite as well as a surgery center.

Dr. Schoenberg said it has been an easy transition because the surgery is the same, but easier. Because there’s no PI, you no longer need to instill a miotic agent at the end of surgery, so it’s one less surgical step, and there are no induced headaches or additional costs. In addition, physicians might be more comfortable with a somewhat lower vault. The ICL comes with four physical sizes corresponding to how much the white-to-white or sulcus-to-sulcus distance is.

Dr. Zaldivar said the surgery is faster than before, taking 4.5 minutes per eye in his hands. “I always check patients’ vault with intraoperative OCT, and I rotate the lens 90 degrees to decrease vault in the vertical meridian in cases of excessive vault,” he said. If you don’t have intraoperative OCT, check the patient at the slit lamp right after the procedure, Dr. Zaldivar said. Since the launch of the EVO ICL, he has abandoned the use of acetylcholine after the procedure and checks every patient’s IOP 4 hours after the procedure.  

Results

Dr. Williamson said it’s rare to have a patient who isn’t better than 20/20 postop. “It seems like everyone bilaterally is 20/20, and the majority are better than 20/20. It has restored that ‘wow’ factor,” he said. “Most of these patients have been told that there’s nothing that can be done for them, so to tell them that there’s something we can do and have them seeing better than 20/20 hours after the procedure is life changing.

“I think my EVO ICL patients are happier, that makes me happier, and that’s why I’m recommending it so much more,” Dr. Williamson said. He added that it’s nice to have an option that avoids the cornea, making a refractive procedure available to patients who might have a “suspicious cornea.”

Dr. Schoenberg has been impressed so far with results and said that patients are thrilled as well. “I think the vision quality is very good. The reliability of the lens is excellent,” he said. “I love LASIK, but the more treatment you do, the less precise your treatment becomes. With the ICL, the surgery is the same whether you’re treating –3 or –16, so there’s a tight response curve.”

The one thing that can throw off the results is the glare, and he said he has done one explant due to glare. 

Dr. Walton has also been having success with the EVO ICL. “The fact that the ICL can coexist in the moderate myopia world with as successful a procedure as modern LASIK speaks to the amazing optics and materials engineering,” he said. “In the high myopes who still have accommodation or aren’t ready for lens replacement, it’s a phenomenal way to improve quality of life.”

He added that for cataract surgeons and refractive surgeons who are new to the ICL, it’s important to make sure the lens unfolds right side up, with a right-sided leading corner aqueous port. He also said to be gentle, and don’t chase bubbles at the end without viscoelastic in the eye, since a chamber collapse could result in touching the anterior capsule.

In terms of refractive predictability, Dr. Zaldivar considers the ICL among the most predictable refractive procedure available, with 98.4% within 0.5 D of target. “In our hands, it has the highest level of satisfaction, with 99% of patients extremely satisfied,” he said.

“Given the significant improvements in vision and quality of life made possible by the ICL, and the high degree of patient satisfaction, I think the benefits of ICL implantation outweigh the risks,” he said. 

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About the physicians 

Evan Schoenberg, MD
Georgia Eye Partners
Atlanta, Georgia

Neda Shamie, MD
Maloney-Shamie Vision Institute 
Los Angeles, California

Bennett Walton, MD
Slade & Baker Vision
Houston, Texas

Blake Williamson, MD
Williamson Eye Center
Baton Rouge, Louisiana

Roger Zaldivar, MD
Instituto Zaldivar
Mendoza, Argentina

Relevant disclosures

Schoenberg: None 
Shamie: STAAR Surgical 
Walton: None
Williamson: STAAR Surgical 
Zaldivar: None

Contact 

Schoenberg: evan.schoenberg@gaeyepartners.com
Shamie: ns@maloneyshamie.com
Walton: drwalton@visiontexas.com
Williamson: blakewilliamson@weceye.com
Zaldivar: zaldivarroger@gmail.com