Frequently Asked Questions

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The Implantable Collamer Lens for short-sightedness and astigmatism is a refractive lens also known as a phakic IOL. “Phakic” meaning that the natural lens of the eye is in place, and “IOL” meaning intraocular lens, or a lens inside the eye. The EVO is a posterior chamber implant that is introduced through a small incision in the eye and is placed behind the iris (the coloured part of the eye), and in front of the natural crystalline lens in order to improve your short-sightedness and astigmatism.

The EVO Visian ICL is designed for patients who are between 21 and 60 years old. Those who are short-sighted with mild to severe myopia (-0.5D to -20D). Patients who are long-sighted with mild to severe hyperopia (+0.5D to +10.0D. Those with an astigmatism between 0.5 and 6.0 D. Are looking for a procedure that doesn’t create dry eye syndrome

In order for your surgeon to get the most out of an EVO Visian ICL for you, your eyesight should not have a change in prescription of more than .5D in a year.


Patients who are pregnant and nursing and patients with a narrow angle in the front chamber of their eye, because in this case the space for the EVO lens would be too small. The patient education booklet provides an additional list of conditions that should be taken into consideration when making a decision about the EVO procedure.

The key benefit of EVO surgery is the permanent correction or reduction of your short-sightedness, long-sightedness or astigmatism allowing you to see clearly without eyeglasses or contact lenses or reduce your dependence upon them. In addition to the improvement of your uncorrected vision (vision without eyeglasses or contact lenses), your best corrected vision (best vision with contact lenses/eye glasses) may be improved.

The material is called Collamer® , a collagen co-polymer that contains a small amount of purified collagen which is proprietary to STAAR Surgical; the remainder is made of a similar material to that found in soft contact lenses. It is very biocompatible (does not cause a reaction inside the eye) and stable. It also contains an ultraviolet light filter.

Prior to being placed on the market, the EVO was subject to extensive research and development. Today, more than 1,000,000 lenses have been implanted worldwide. In a US clinical study, over 99.4 percent of patients would have the procedure again. The EVO has a track record of excellent clinical outcomes.

EVO is intended to remain in place without maintenance. The lens can be removed by your eye care professional if needed in the future. If your physician removes the lens, you will lose the benefit of your vision correction.

No. EVO is positioned behind the iris (the coloured part of the eye), where it is invisible to both you and others. Only your eye care practitioner will be able to tell that vision correction has taken place.

EVO is not typically noticeable after it is implanted. It does not attach to any structures within the eye and does not move around once in place.

The EVO surgery is performed on an outpatient basis which means that the patient has surgery and leaves the same day. The procedure itself usually takes 20-30 minutes or less. The patient will need someone to drive them home on surgery day. A light, topical or local anaesthetic is administered. There is very little discomfort during or after surgery. Some eye drops or medication may be prescribed and a visit with your eye care professional is usually scheduled the day after surgery.

Follow all of your eye care professional’s instructions before and after implantation of the EVO lens. Take any prescribed medication and schedule all recommended follow-up visits with your eye care professional, usually on an annual basis after the healing of the surgery. Contact your eye care professional immediately if you should experience a problem.

Important Safety Information

It is important to consider that EVO Visian® Implantable Collamer Lenses (ICL) are approved by the local health authority, which means they have been determined to be safe and effective. As with any procedure, there are risks to consider. If you have any questions or concerns it is always best to speak with a certified EVO Visian® Implantable Collamer Lens (ICL) doctor. The EVO Visian ICL family of lenses include EVO Visian ICL, EVO Visian Toric ICL, EVO+ Visian ICL, and EVO+ Visian Toric ICL and are designed for the correction/reduction of low to high myopia (-0.5 to -20.0 diopters (D)) and the correction/reduction of myopia in patients with up to -20 D of myopia with less than or equal to 6.0 D of astigmatism. The EVO Visian ICL family is indicated for use in phakic eye treatment and for: The correction/reduction of myopia in adults 21 – 60 years of age with power ranging from -0.5 D to -20.0 D at the spectacle plane. With an anterior chamber depth (ACD) equal to or greater than 3.0 mm, as measured from the corneal endothelium to the anterior lens capsule. This extended age range covering over 45 to 60 years of age only applies to the myopic EVO Visian ICL family, and only in countries covered by the jurisdiction of the EU Notified Bodies where the CE Mark is recognised (i.e., the EU, EEA, and EFTA). The EVO Visian ICL family of products currently in inventory do not have the updated Directions For Use (DFU) with this new wording yet, but it will be incorporated over time. EVO Visian ICL surgery does not eliminate the need for reading glasses, even if you have never worn them before. The EVO Visian ICL represents an alternative to other refractive surgeries including, laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), incisional surgeries, or other means to correct myopia such as contact lenses and eye glasses. The EVO Visian Toric ICL is intended to correct or reduce astigmatism (up to 6.0 D) you may have (the EVO Visian ICL is not intended to treat your astigmatism). Implantation of an EVO Visian ICL is a surgical procedure, and as such, carries potentially serious risks. The following represent potential complications/adverse reactions reported in conjunction with refractive surgery in general: additional surgeries, cataract formation, loss of best corrected vision, raised pressure inside the eye, loss of cells on the innermost surface of the cornea, conjunctival irritation, acute corneal swelling, persistent corneal swelling, endophthalmitis (total eye infection), significant glare and/or halos around lights, hyphaema (blood in the eye), hypopyon (pus in the eye), eye infection, Visian ICL dislocation, macular oedema, non-reactive pupil, pupillary block glaucoma, severe inflammation of the eye, iritis, uveitis, vitreous loss and corneal transplant. Before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially the potential benefits, risks and complications. You should discuss the time needed for healing after surgery.

References

References

1. Patient Survey, STAAR Surgical ICL Data Registry, 2018

2. Sanders D. Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for Low Myopia. Cornea. 2006 Dec; 25(10):1139-46. Patient Survey, STAAR Surgical ICL Data Registry, 2018

3. Naves, J.S. Carracedo, G. Cacho-Babillo, I. Diadenosine Nucleotid Measurements as Dry-Eye Score in Patients After LASIK and ICL Surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2012.

4. Shoja, MR. Besharati, MR. Dry eye after LASIK for myopia: Incidence and risk factors. European Journal of Ophthalmology. 2007; 17(1): pp. 1-6.

5a. Lee, Jae Bum et al. Comparison of tear secretion and tear film instability after photorefractive keratectomy and laser in situ keratomileusis. Journal of Cataract & Refractive Surgery , Volume 26 , Issue 9 , 1326 - 1331.

5b. Parkhurst, G. Psolka, M. Kezirian, G. Phakic intraocular lens implantantion in United States military warfighters: A retrospective analysis of early clinical outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481.

*American Refractive Surgery Council