Visian and Verisyse Phakic Lens Implants
For people who are very nearsighted (-10 to -20 diopters of myopia) we offer a promising new procedure: a lens implant that is intended for patients who are not suitable candidates for refractive surgery like LASIK and PRK.
Depending upon the architecture of the eye (including the size of the pupil and the thickness of the cornea,) LASIK and PRK can be used to correct up to approximately -10 diopters of nearsightedness. People with a higher degree of nearsightedness often are not safe surgical candidates. In September of 2004, the Food and Drug Administration approved the first implantable lens designed to help people who are too nearsighted for these cornea refractive surgeries.
In the past, being told that you were not a candidate for LASIK simply meant that there were no other options to surgically correct your vision. But now, phakic lens implants such as the Visian ICL™ and the Verisyse IOL™ can be used to permanently correct your vision.
The word "phakic" means that your natural lens is left in the eye. This is important because your natural lens plays a critical role in helping your eye adjust between seeing objects that are near and far. Both the Visian and Verisyse are considered phakic lenses, and although very similar, each has unique properties. We will recommend the correct lens for you upon a thorough and complete examination.
About the Visian ICL
The implantation procedure for the Visian ICL involves a procedure similar to that of cataract surgery. The main difference is that, unlike cataract surgery, the Visian ICL procedure does not require the removal of the eye’s crystalline lens. And unlike the LASIK or PRK refractive procedures, the Visian ICL procedure does not involve the removal of sensitive eye tissue.
The Visian ICL (implantable contact lens) is the first lens of its kind to be approved by the FDA for use in the United States. It is based on many years of research and development in adapting the proven technology of the IOL (intraocular lens) used for cataract surgery. The IOL cataract procedure is familiar to ophthalmologists and is performed safely on millions of patients each year. While the technology is similar, the Visian ICL procedure differs from cataract surgery as the natural lens is not removed from the eye. Instead, the Visian ICL is placed in front of the natural lens and the two work together to correct your vision.
The entire procedure for the implantation of the Visian ICL will take about 15 to 30 minutes. Most patients say it is relatively painless because of the numbing agents used.
How does Visian compare with LASIK?
During clinical trials, researchers compared the outcomes of Visian patients to those of LASIK patients with similar prescriptions. The patients involved in the study were very nearsighted (8-12 diopters of nearsightedness prior to surgery), and their visual outcomes were measured at regular intervals post-operatively. The result showed that Visian provided superior post-operative visual acuities when compared with LASIK population. For Visian patients, 52% of patients demonstrated post-operative uncorrected visual acuities of 20/20 or better, while only 36% of LASIK patients were able to achieve 20/20 vision or better following surgery. Additionally, patients who received the Visian lens also reported a better quality of vision than those who had undergone LASIK, and the Visian ICL has been shown to induce significantly fewer higher order aberrations than LASIK. In fact, symptoms such as glare, halos, double vision, night vision difficulty and night driving difficulty were largely absent or mild after 3 years post-operatively.
About the Verisyse™ ICL
The Verisyse™ Phakic IOL is used to treat moderate to severe myopia, the medical term for nearsightedness. With over 18 years of use and 150,000 procedures performed worldwide, results prove that the Verisyse™ design is safe and effective for very nearsighted people who are tired of thick glasses and are not candidates for Custom LASIK.
How does Verisyse compare with LASIK?
Verisyse clinical investigators conducted a randomized comparison of Verisyse with LASIK in myopic patients correcting between -9D and -19.50D of nearsightedness.3 Sixty-one patients (90 eyes) were studied with a mean refraction of -13.50D. Thirty percent of patients received the Verisyse in one eye and LASIK in the other eye. Results provided in the table below demonstrate that both patient groups ended with similar refractions post-operatively. However, the extreme flattening of the cornea that occurs with LASIK in this highly-nearsighted population has caused some surgeon concerns about vision qulaity post-LASIK. As demonstrated in the chart, patients with extreme nearsightedness did better with Verisyse in their visual acuity, lines of vision gained, and minimal loss of contrast sensitivity.
How effective is the Verisyse Lens?
Patients who choose the Veryisyse lens usually have been frustrated with glasses and contacts for a very long time. Their degree of nearsightedness is such that it was often difficult for them to be fitted with glasses or contacts. FDA trial data indicates the vision improvement with Verisyse is substantial. This chart shows the vision Verisyse patients have in their first implanted eye at 3 years post-op without the use of any glasses or contacts.
About the Verisyse™ procedure
Depending upon your individual measurements and visual needs, your surgeon will recommend either the Visian or Vesisyse lens. The phakic lens implant procedure is performed on an outpatient basis and takes about 15 to 30 minutes. Usually, one eye is treated at a time.
- Drops will be placed in your eye in order to reduce the pupil size.
- Your surgeon will use an instrument to comfortably hold your eyelids open during the procedure.
- A local anesthetic is given to numb your eye, so the procedure is virtually painless.
- A small incision is made in the cornea for the phakic lens can be gently inserted.
- The Visian ICL is placed behind the iris (the colored part of the eye) and in front of your natural lens. If your surgeon is implanting the Verisyse IOL instead, it is centered in front of the pupil (the black part in the center of your eye), and is gently attached to the iris to hold the lens in place.
- The small incision is closed with microscopic stitches that dissolve on their own.
- A temporary shield is placed over your eye to protect it during the time just after the procedure.
Are you a candidate for phakic lens implant surgery?
A series of tests performed in our office will help you decide if the Visian or Verisyse procedure is right for you. In general, the requirements for phakic lens implant surgery are:
- Your eyes are healthy with no eye disease, iris, pupil, or corneal abnormality, or history of retinal detachment.
- Your nearsightedness can be corrected with lenses between -5.0 to -20.0 diopters.
- You have 2.5 diopters or less of astigmatism.
- Your eyes are stable and your nearsightedness has not changed more than 0.50 diopters for 6 months prior to surgery.
- You are not currently pregnant or nursing.
Frequently Asked Questions
How many patients have had phakic lens implant procedures?
The Verisyse™ Phakic IOL design has been successfully used in Europe for 18 years. More than 150,000 phakic procedures have been performed worldwide. In the United States, clinical studies of the Verisyse procedure began in 1997 and the lens was approved in 2004. Rigorous clinical investigations have been conducted using the Visian lens over the past 3 years, and the FDA approved its use in the United States in 2005. Over 50,000 Visian Lenses have been implanted worldwide.
Is the procedure painful?
Local anesthesia is used to numb your eye prior to surgery so most patients experience no pain during the procedure. Although some discomfort is normal during the healing process, the vast majority of patients experience little or no pain after the procedure.
Can I see well up close and at a distance after the procedure?
Most people who have the Visian or Verisyse procedures see well up close and at a distance because their natural crystalline lens is left in place allowing natural adjustments to focus on near and distant objects.
Will I be able to see or feel the lens in my eye?
Once implanted, the lens is virtually undetectable, and you enjoy a cosmetic appearance that is natural. Typically, only your doctor will be able to tell that vision correction has taken place.
Does the lens require maintenance?
Unlike contact lenses, the lens does not require any maintenance. It is extremely important to attend all follow-up appointments and schedule annual exams with your surgeon to help ensure your long-term eye health.
Can the lens slip or fall out?
Once implanted, the lens will not slip or fall out. It is designed to remain in your eye permanently, and you will not be able to feel it.
How long does the lens last?
The Visian and Verisyse lenses are designed to provide permanent vision correction. As long as patients don’t suffer from other vision health problems (such as cataracts) that may affect the lens, it will provide high quality vision for life.
Exactly where is the lens placed in the eye?
The Visian ICL is placed in the "posterior chamber," behind the iris (the colored part of the eye) and in front of the eye’s crystalline lens. The lens does not touch any internal eye structures and stays in position. The Verisyse is placed just in front of the pupil and is gently attached to the iris to hold the lens in place.
What is the track record of the Visian ICL?
Extensive research and development preceded the introduction of the Visian ICL. It is now being used by more than 50,000 patients worldwide. The Visian ICL provides excellent and stable outcomes and the satisfaction rate among patients is extremely high – above 99% (FDA U.S. Clinical Trial).
What is the Visian ICL made of?
The Visian ICL is made of Collamer, an advanced lens material that is highly biocompatible. Collamer does not cause a reaction inside the eye and contains an ultraviolet filter that provides protection to the eye.
What if my vision changes?
Both the Visian and Verisyse lenses offer treatment flexibility. If your vision changes dramatically, the lens can be removed and replaced, or another procedure can be performed at any time. You can wear glasses or contact lenses if necessary. The lens does not help presbyopia (difficulty with reading in people over 40), but you can add reading glasses if needed.