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EVO ICL FDA approval: Now available in the United States

Category: EVO ICL

EVO Visian ICL FDA Approval

EVO Visian ICL, which treats nearsightedness to provide visual freedom from glasses and contact lenses, is available in San Antonio, Texas at Parkhurst NuVision after getting FDA approval. Parkhurst NuVision was the first in the country to perform the EVO ICL post-FDA approval.

What Is EVO ICL?

EVO Visian® ICL (referred to as “EVO”) is an evolutionary innovation in vision correction surgery. EVO ICL is an implantable lens placed just below the surface of the eye that corrects nearsightedness (with or without astigmatism) and gives crisp, clear vision to patients who are seeking freedom from the inconvenience, hassle, and ongoing expense of contact lenses and glasses. The EVO lens has been popular in Europe where over 1 Million EVO lenses have been implanted! As the leading clinical investigator in the FDA study, Dr. Gregory Parkhurst with Parkhurst Nuvision is excited to be the first vision correction surgery practices to offer EVO to his patients and to the US!

EVO ICL Patient Satisfaction

“As the highest volume EVO implanter in the FDA clinical study, and with over 10 years of experience in both my military and civilian career with the Visian ICL, the EVO will be an important technology to help free patients from the burdens of glasses and contacts in a simple 5-minute procedure. I have seen through the clinical study how amazed my patients are with EVO, and I am excited to be able to offer it to everyone seeking visual freedom,” said Gregory Parkhurst, MD.

Myopia, commonly known as nearsightedness, is the most common vision problem in the world, affecting approximately 1.9 billion people—estimated to increase by 50% by the year 2050. Vision correction solutions such as EVO Visian ICL give people the freedom and flexibility to live active lives without the inconvenience or ongoing costs of glasses or contact lenses.

“I had been waiting for EVO ICL and now that I have it, it was one of the best decisions I could have made for myself,” shared an EVO ICL patient. “Being someone that was legally blind without my contacts and now I am just able to get up and see everything is truly amazing. The procedure was so quick and painless. I was even able to go to work the next day. EVO is the greatest gift I could have received.”

EVO ICL Benefits

Long-term vision correction with the EVO ICL is a quick and effective procedure that offers many benefits. EVO can correct vision for a wide range of eye prescriptions and delivers excellent night vision with built-in UV protection. The EVO lens may be an ideal option for patients who don’t prefer to wear glasses and contact lenses and are not candidates for laser eye surgery. EVO is designed to provide permanent vision correction, and for added peace of mind, it is both removable and replaceable if needed.

EVO ICL: Who Is A Candidate?

Each individual patient has unique vision correction and eye care needs, and it is important to understand the benefits and potential risks of any vision correction solution. An Online or in-person consultation with an eye doctor at Parkhurst NuVision in San Antonio can give you the information you need to make an informed decision on vision correction procedures. The EVO ICL is indicated for patients with a prescription between -3.0 up and -20.0 D, and EVO can also treat astigmatism from 1.0 D to 4.0 D. To see if you are a candidate for EVO or one of many other procedures that Parkhurst NuVision offers, please call Parkhurst NuVision at 210-585-2020 or schedule a consultation here.

EVO ICL FDA Study

As the highest volume surgeon in the EVO ICL FDA clinical study, we have been excitedly awaiting the group results. The EVO ICL was approved based on a study that 629 eyes were implanted with the EVO ICL and the EVO+ ICL. The patients in the study had myopia and myopic astigmatism, with the average pre-operative prescription of -7 to -8 diopters of myopia and 2 diopters of astigmatism. The results showed that 90.4% within ± 0.50 D of target and 98.9% within ±1.00 D of target. The mean uncorrected distance visual acuity was -0.059 ± 0.10 logMAR, which means on average these patients were seeing better than 20/20 without glasses (despite having a strong prescription with astigmatism)! No patients developed pupillary block, anterior subcapsular cataracts, or had elevated IOP due to angle narrowing or pigment dispersion. The results from this study, which likely will be presented in more detail at ASCRS in April, concluded that the EVO ICL demonstrated a high level of uncorrected vision (vision with glasses or contacts) and accuracy of refraction correction.

What is the difference between EVO and EVO plus?

The main difference between the EVO ICL and the EVO+ or EVO plus ICL is the size of the optical diameter. The EVO plus ICL has a larger optical zone(5.0 to 6.1mm) compared to the EVO ICL (4.9 to 5.8mm), which may result in less halos around lights at night.

EVO Visian ICL vs Visian ICL

The main difference between the EVO ICL and the Visian ICL is that the EVO ICL has a central port which eliminates the need for a pre-surgical step called a laser iridotomy.

Does the EVO ICL come in one size?

The EVO ICL comes in four different sizes in the US (12.1, 12.6, 13.2, and 13.7). In the pre-operative process, we will take ultrasound measurements to decide which lens is best for you. We still size the EVO ICL using the Parkhurst nomogram, which in a recent article in JCRS, showed that it was the most accurate way to size ICLs.

How soon could I get the EVO ICL?

The EVO ICL is available now. Patients are traveling from all around the country to Parkhurst NuVision to get EVO! If the EVO ICL or EVO plus ICL that you would need is not available yet, that customized lens will need to be manufactured and could take about a month for that lens to be created.

Outside the United States over 1 million procedures have been done. If you are looking to learn more about the long-term data that we already know about the EVO Visian ICL click here. If you have been waiting for the EVO ICL and are interested in flying into San Antonio to get the ICL done, please call us at 210-585-2020 or request an appointment.