Implantable Contact Lens – EVO ICL

Deciding on the vision correction procedure that’s right for you is an important one. The VISIAN ICL/LASIK/PRK COMPARISON – (Printable PDF) provides a general comparison of the major differences between the Visian ICL, LASIK and PRK. It is NOT an exhaustive list, nor is it a substitute for the advice of your doctor. ONLY AN EXTENSIVE EXAMINATION BY YOUR EYE CARE PROFESSIONAL CAN PROVIDE THE INFORMATION NECESSARY TO DETERMINE WHICH PROCEDURE IS UNIQUELY SUITED FOR YOU. To determine if you are a suitable candidate, contact us to schedule a complimentary evaluation.

The Visian ICL™ was U.S. FDA approved in December 2005, the Toric ICL was FDA approved in December 2018, and the EVO ICL (fenestrated -no Peripheral Iridotomy necessary, larger diameter optic in lower myopic ranges) was FDA approved in March 2022. The ICL is intended for use in adults with healthy eyes and stable spectacle and / or contact lens prescriptions. It is designed for:

• The correction of Myopia ranging from -3 to -15 diopters (D) at the spectacle plane
• The reduction of Myopia ranging from -15D to -20D
• 1 to 4 diopters of astigmatism correction
• Adults 21 years of age or older with a stable refractive history within 0.5D for 1 year before implantation

The Hyperopic ICL™ is NOT U.S. FDA approved and is NOT available in the USA. However, The Hyperopic ICL has been available for use in Canada and many other countries for many years.

The Visian ICL™ may reduce or eliminate your dependence on glasses or contact lenses. In a clinical study of 294 patients implanted with the Visian ICL™, 95 percent had 20/40 or better vision (considered standard vision necessary to obtain a driver’s license), and 59 percent had 20/20 or better after three years.

There is not much patients need to do to prepare for vision correction with EVO Visian ICL. During your consultation with your eye doctor, you will undergo a thorough eye exam and discuss why EVO Visian ICL may be a great option for you. Your procedure will be scheduled, and a member of our team will advise you of any preoperative guidelines, as well as postoperative instructions. You will come to our surgery center. You may receive a mild sedative. Topical numbing drops are used. The brief procedure is painless. You will use antibiotic/steroid eye drops for a week. You should not swim for a week. Otherwise, there are no restrictions.

One eye is operated on at a time. The second eye may be implanted with the ICL later the same day, the next day, or a week or more after the first. In the interim, you can generally continue contact lens wear in your untreated eye, if applicable. Your doctor will help you decide which strategy is best for you.

The ICL is not noticeable after it is implanted. It does not attach to any structures within the eye and does not move around after it is in position.

No. The ICL is designed to remain in place within the eye without maintenance. We recommend an annual eye examination to make sure that everything is fine.

No. It is not possible for an untrained observer to "see" this implant in your eye when looking at you from any distance. In fact, it is difficult for an ophthalmologist to detect this implant in a non-dilated pupil when looking through a slit lamp set for low magnification. It only becomes more obvious after the pupil is pharmacologically dilated during a routine eye examination.

The Visian ICL is a specially designed US FDA approved clear, transparent lens intraocular implant. As an early participant in the US FDA ICL Myopia study which began in 1998, Dr Erdey has over 24 yrs experience with this implant. It is indicated to reduce or eliminate corrective lenses. It is placed BEHIND the iris, it does NOT change iris color in the way "tinted" soft contact lenses can. It is not possible for an observer to "see" this implant in your eye when looking at you from any distance.

Another implant, the HumanOptics Iris Reconstruction lens is US FDA approved and ONLY indicated to reverse complete or partial aniridia (congenital or traumatic iris loss). It is custom designed to “match” the iris color and texture of the contralateral eye. It is ABSOLUTELY CONTRAINDICATED for cosmetic iris color change! This iris implant should NOT be confused with other potentially dangerous and blinding intraocular cosmetic opaque implants designed to be implanted in FRONT of the iris to change iris color. These have not been studied or approved. There is NO long term safety data. They are available to the uninformed in several unregulated international markets and many who have travelled to receive them have developed severe ocular complications including iris atrophy, glaucoma, optic neuropathy, cornea decompensation etc requiring explantation of the implant and other heroic surgical measures to save the eye. Please review the references below:

https://www.sciencedirect.com/science/article/pii/S2451993618300367

https://www.karger.com/Article/FullText/492745

No. The Visian ICL is made of a porcine copolymer clinically proven to be biologically “inert”. This means the body’s immune system does not react to it once implanted in the eye.

• In patients with myopia of -3.0 to -15.0 Diopters (D), the vast majority do not require corrective lenses after ICL implantation. However, in patients with extreme myopia, -15 to -20 D or higher (“Coke-bottle” spectacles), use of corrective lens after ICL implantation may be necessary to correct any residual refractive error. In either case, complete independence from corrective lenses while very common, is not guaranteed. Glasses or contact lenses may only be needed occassionally (ie. driving at night or other activities performed in low light conditions). In certain cases, supplemental Laser Vision Correction to “fine tune” the result may be considered.
• Individuals in their teens to mid 20’s may naturally develop gradual changes in their spectacle or contact lens prescription due to continued growth of the eye. Implanting the ICL after your spectacle or contact lens prescription has remained stable for a year or more reduces the possibility that dependence on corrective lenses could again develop. Supplemental Laser Vision Correction to “fine tune” the result could be considered in those few who experience a refractive shift years after ICL implantation.
• In patients age 43 or older with presbyopia the ICL is capable of reducing or eliminating the need for distance glasses, but reading (near vision) glasses will still be required.
• As the eye ages, cataract formation may shift the refraction of the eye. If such a patient had an ICL implanted years earlier without subsequent need for distance corrective lenses, they may once again require glasses because of changes in the power of the crystalline lens induced by the cataract. More dramatic shifts in an eye’s refraction accompanied by optical degradation due to cataract formation are easily reversed by removal of the ICL followed by cataract surgery with an intraocular lens.

Many patients who developed cataracts years after they had a cornea refractive procedure (LASIK, PRK, RK) have had successful cataract surgery and intraocular lens (IOL) implantation with good results. However, the required implant power is more challenging to predict because the modified corneal curvature cannot be accurately measured. Further, the optics of the combination (modified cornea with an IOL) are generally not as optimal as a similar patient who develops a cataract years after ICL implantation. In the latter case, the ICL is easily removed, the original corneal curvature is preserved (never modified) and cataract surgery with an intraocular lens is implanted, yielding superior optical results.

No surgical procedure is risk-free. There are potential complications associated with the surgery itself. These include: irritation of the conjunctiva, corneal swelling, eye infection, non-reactive pupil and irritation of the iris. In the vast majority of cases, these complications are short term, transient in nature, and will be treated by the doctor performing the surgery.

Other complications that can occur are associated with the correction of your vision; these include: halo and/or glare around lights, under or over correction of your vision (which may require retreatment), and induction of higher order aberrations that can impact quality of vision. Again, the vast majority of these complications will be treated by the doctor performing your surgery. Unlike cornea-based procedures (LASIK, PRK), the Visian ICL procedure does not cause or exacerbate dry eye and the ICL can be removed if needed.

Early complications reported at the time of surgery or within the first week after Visian ICL surgery include: removal and reinsertion of the Visian ICL at the time of initial surgery; removal or replacement of the Visian ICL after surgery; pupillary block resulting in raised eye pressure, which may necessitate the creation of an additional peripheral iridotomy to improve fluid flow.

Potential Complications that can occur after the first week post surgery: The proximity of the ICL to the natural crystalline lens raises the possibility of the development of small cloudy areas or opacities on your natural crystalline lens, which may or may not cause visual symptoms. In a very limited number of cases (1.7% of eyes that received an ICL at seven-year follow-up in the US FDA Study) these opacities can become more widespread and develop into a cataract. Most cataracts occurred in those with very high myopia (> -15.0 Diopters). Experience also suggests that the development of visually significant cataracts is somewhat higher in patients who receive an ICL above age 46 (“off FDA label”). However, cataracts are considered far easier to fix than corneal complications following LASIK surgery.

Other rare complications include cornea endothelial cell loss (a loss that occurs naturally with age) from the back surface of the cornea (which may require ICL explantation and could result in a corneal transplant) and an increase in the pressure inside of the eye (post-op drops are used to minimize pressure increase).

Current evidence supports ICLs as being a very effective option for most patients who are suitable candidates. Your doctor will provide a more thorough discussion of the risks and benefits of this procedure during your office visit. With this information, you can make an informed decision about choosing this or other options available to reduce or eliminate your myopia (nearsightedness).

The US FDA labeling for the ICL is for use at "age 21" or older. Refractive surgery (ICL, LASIK, PRK) can occasionally be offered to younger patients “off label” if refractive stability is demonstrated but there is no guarantee future refractive shifts will not occur, requiring glasses in certain lighting conditions or surgical enhancement.

The refractive elements in the younger eye are usually still maturing, often requiring periodic changes to the spectacle or contact lens prescription until “stability” occurs. Generally, if there is no documented prescription change after at least one year, it is reasonable to consider ICL implantation.

The Visian ICL is designed to correct pre-existing myopia with or without astigmatism. It does NOT restore the natural loss of accommodative amplitude with increasing age (Presbyopia). This causes glasses dependence (readers) for the near vision tasks you describe. While there are several promising options under development for this condition, cataract patients with mature cataracts can consider advanced intraocular lenses with optics designed to improve simultaneous uncorrected distance, intermediate and near visual acuity.

When younger, the spectacle/contact lens prescription can shift until a healthy eye’s optical elements have achieved maturity - generally sometime during the low to late 20’s. Once stability is reached, the prescription stabilizes. If there is NO significant change in prescription for a year or more, refractive surgery (Visian ICL, LASIK, PRK etc) can be considered. Some who demonstrate a period of refractive stability and subsequently have LASIK or the ICL can still gradually experience a refractive shift causing some dependence on glasses because of continued maturation of the eyes optical elements. Glasses, contact lenses, or repeat LASIK enhancement can be considered in these cases.

When older, the prescription can again gradually shift for a variety of other reasons, usually due to early cataract formation. If ICL, LASIK, PRK had been performed years earlier, once a cataract is “mature” enough to qualify for removal an intraocular lens implant is placed with a power chosen to neutralize the original refractive error with an adjustment made to compensate for the modified corneal curvature. If an ICL had been implanted years earlier, the ICL is first removed and cataract surgery performed. The intraocular lens power is chosen to neutralize the original refractive error. This calculation is much simpler and more accurate than if LASIK/PRK had previously been performed. In either case, the final prescription should remain stable thereafter.

In rare patients who received LASIK, the prescription can shift due to corneal instability. Your eye doctor can diagnose this and advise corrective options.

Unfortunately NO Medical Health Insurance company classifies Refractive Surgery (ICL, LASIK, PRK) as a covered benefit.

"Eye" insurance generally covers cost of refractions, glasses or contact lens and does not cover medical or surgical eye conditions

Richard Erdey, MD implants first EVO+ Visian ICL in Central Ohio!

3/28/2022 Staar Surgical announces U.S. FDA approval Of EVO (fenestrated) Visian Implantable Collamer lenses.

North American Visian Excellence Group, Colorado Springs, CO. 8/17-18/2013

Read: Erdey Searcy Eye Group News 7/20/2011

Read: National News Release - 3/1/2010

Read: Columbus Dispatch 3/3/2006

View: 10TV 5PM News 3/2/2006

Dr. Erdey is among the first to implant the ICL following U.S. FDA approval. His patient, Laurel Santino, MD, an Obstetrician practicing in Lancaster , is interviewed.

View: 10TV 11PM News 3/2/2006

Read: Review of Ophthalmology 2001 -

Read: Review of Ophthalmology 2001 -

View: NBC4 News 1998