What is a “Phakic IOL or ICL”?
The word “phakos” is Greek for lens of the eye. “IOL” is an abbreviation which stands for “intraocular lens”. An IOL is a lens that is placed inside the eye. The term “phakic IOL” means an artificial lens that is placed permanently inside a patient’s eye to correct high amounts of nearsightedness without removing the patient’s own natural lens. It is also known as the “implantable contact lens” (ICL).
The “phakic IOL” is a lens made of either medical-grade plastic (polymethylmethacrylate), or a new high technology co-polymer consisting of a combination of soft contact lens material and collagen. The phakic IOL acts in concert with the patient’s own lens and cornea to allow light rays to focus on or near the retina, thereby diminishing or (possibly) eliminating the patient’s very high degree of nearsightedness.
The intraocular lens has been used since the late 1970s to optically correct the eye once the natural lens of the eye has been removed during cataract surgery. I have performed over 10,000 implantations of IOLs in association with cataract surgery in my own Federally-certified and State-licensed ambulatory surgery center since 1983.
There are two lenses that have been approved by the FDA to be implanted into the eye without removal of the patient’s own natural lens. One lens is designed to be placed behind the iris (the colored portion of the eye) just vaulting the top of the patient’s own natural lens. The other is physically hooked to the iris which is anatomically over the patient’s lens, but below the patient’s cornea. I specialize in the implantation of both lenses.
Why would one contemplate having a phakic IOL?
Phakic IOLs are designed for patients who desire reduced dependence or (possibly) elimination of glasses or contact lenses, but who are not candidates for LASIK, PRK, LASEK, or EPI-LASIK due to a very high amount of nearsightedness and/or a thin, flat or irregularly shaped cornea. Unlike corneal procedures such as LASIK, PRK, LASEK, and EPI-LASIK, the diminution or elimination of nearsightedness is accomplished not by operating on the surface of the cornea, but by optically correcting the eye by placing a permanent artificial lens inside the eye. For the very nearsighted patient (-11.00 and above) the phakic IOL may be optically better than LASIK or PRK/LASEK/EPI-LASIK in that there is better contrast vision, improved corneal architecture, and no chance to have an irregular optical surface from microfolds. Studies have shown better vision with and without glasses following phakic IOL versus LASIK surgery for these patients. (Reference: D.R. Sanders, J.A. Vukich, Comparison of ICL and LASIK for Moderate to High Myopia. Cornea May 2003; Vol. 22, #4, p324-331)
Who would be a good candidate for this procedure?
Patients who are very nearsighted, and/or those patients who have corneas which are abnormal with respect to being too thin, too flat, or irregularly shaped would be good candidates, provided that the anatomy of their eye can safely accommodate the lens. For example, patients must have enough room to implant the lens (the anterior chamber depth), and patients should not have coexisting ocular conditions such as cataract, glaucoma, chronic inflammation (uveitis), or scarring inside the eye. Patients with abnormal corneas may undergo the procedure, however, generally cannot have LASIK to “fine tune” or adjust the vision following implantation.
What are the alternatives to phakic IOLs?
The alternatives to correct high amounts of nearsightedness and astigmatism include: (1) Glasses, which are the time tested, tried-and-true method with the highest degree of safety. (2) Contact lenses are also safer than any form of surgery, although there is a small risk of developing a sight-threatening infection. (3) Corneal surgery such as LASIK, PRK, LASEK and EPI-LASIK. However, in patients with high degrees of nearsightedness and astigmatism in combination with a thin or flat cornea it may be impossible to safely achieve full correction of the nearsightedness and/or the astigmatism with corneal surgery. Additionally, the quality of vision with respect to visual acuity as well as contrast acuity may not be as good in the higher degrees of nearsightedness with LASIK, PRK, LASEK or EPI-LASIK as it is with the phakic IOL procedure.
What can I expect before the surgery?
Two very small openings must be placed in the iris (colored part of the eye) using the YAG laser. Each opening measures about 0.5mm in diameter and ensures that the pressure between the chamber behind the iris and the chamber in front of the iris is equalized once the lens is implanted. These small openings are generally placed a week or two prior to implantation of the phakic IOL. The procedure to create the small openings is painless and is performed at our Hayward surgical facility.
What can I expect during surgery?
The surgical procedure for the phakic IOL is performed in our Federally-certified and State-licensed ambulatory surgery center in Hayward. This ensures that the highest quality surgery is performed in the safest and most controlled setting using our dedicated surgical team. The surgery itself takes less than one-half hour and is performed while the patient is awake, but relaxed. The surgery is not painful. An anesthesiologist who administers mild intravenous sedation and monitors the patient is present throughout the case to ensure that there is no discomfort and that the patient is both physically and emotionally comfortable. After anesthetizing the eye, a small (3mm or 6mm) incision is made where the white meets the colored portion of the eye. Additional tiny incisions are made to manipulate the lens safely into position. The lens is then placed through the incision and positioned either below the iris or attached to the iris. In cases using the 6mm incision (required for the AMO Verisyse lens), microscopic sutures are placed and painlessly removed in the office about 3 weeks later The above illustration shows the Verisyse lens implanted in the eye. In the case of the 3mm incision (Staar Visian ICL) no sutures are placed. The patient is then observed post-operatively at the Center to ensure that the lens is in proper position and that the pressure in the eye stays low. The patient is seen the following day and follow-up visits are arranged to ensure proper healing. The patient is instructed in the use of eyedrops which are employed for about one month.
What results can I expect?
The data submitted to the FDA for the Staar Visian lens was based on the results of a multi-center U.S. clinical trial which included 526 eyes followed for up to three years. The data showed that 52% of all eyes were 20/20 or better, 68% of all eyes achieved 20/25 or better vision, and 89% achieved 20/40 or better vision without the use of glasses or contact lenses following the implantation of these lenses. The patient satisfaction rate based on a survey on each patient demonstrated a satisfaction rate of 99.4% at three years post-operatively. The data indicated that 95% of patients with good pre-operative vision and targeted for “zero” post-operative correction had vision without glasses or contact lenses of 20/40 or better after receiving the phakic IOL. 57% had visual acuities without glasses or contact lenses equal to or better than their vision with the best possible glasses or contact lenses pre-operatively. Three year FDA data for the Verisyse lens was similar in that 92% of patients had 20/40 vision or better and 44% had 20/20 or better without glasses or contact lenses. Our own personal experience with both of these lenses is as good or slightly better than the FDA data. It is important to realize that in the FDA trials LASIK, LASEK/PRK/EPI-LASIK or AKs were not performed to enhance, adjust, or “fine tune” the phakic IOL results. Therefore with an adjustment (if your corneal health allows) your results could be better than the FDA trial results.
What if my best possible vision before surgery is not 20/20?
The FDA studies showed that a small percentage of patients actually enjoyed better vision without glasses than they had with glasses before the procedure. However, one must understand that for most patients the best one can expect is vision without glasses to be the same as the vision with glasses before the procedure. For example, if your glasses vision is 20/50 before the phakic IOL, then the best you can hope for is 20/50 vision without glasses after the phakic IOL.
What happens if I do not achieve full correction of my nearsightedness and astigmatism from the phakic IOL?
Although the lens powers are accurate, they are not perfect. Additionally, each individual and each eye heals differently. Accordingly, patients may experience residual nearsightedness, astigmatism, induced astigmatism, or induced farsightedness. Once the eye measurements are stable, which takes a few months following phakic IOL surgery, additional surgery may be required in order to “fine tune” the vision. The additional surgery is not mandatory and “fine tuning” may be achieved with a thin pair of glasses or contact lenses. Depending upon the health of the patient’s cornea, residual myopia, induced farsightedness and/or astigmatism can be treated using LASIK, PRK, LASEK or EPI-LASIK. For patients whose corneas are irregular and abnormal, additional corneal surgery may not be possible and further correction with prescription glasses or contact lenses may be necessary.
Does the lens ever need to be removed or replaced?
The lens is designed to last and to stay in position forever. However, in some cases if the lens is not in the proper position, it may be necessary to reposition the lens or possibly remove it and replace it with a new lens. Sometimes, if there is an associated complication, the lens must be removed, but not replaced.
Are there potential risks of this type of surgery?
Of course, all surgery has potential risks and complications. Although most complications are minor, some can be serious such as the development of a cataract which may require additional surgery. Some complications may even be sight-threatening such as bleeding, infection or retinal detachment. The FDA studies of both the Verisyse and the Visian phakic IOLs over at least a three year period demonstrated an extremely low complication rate. If it were an unsafe or dangerous procedure, the FDA would not have approved the phakic IOL!
What is the cost of the procedure?
The exact cost of the procedure depends on a number of factors referable to your eye and your specific needs. The factors which go into determining the cost of the procedure include the use of our Federally-certified, State-icensed surgery center, an M.D. anesthesiologist, the surgeon fee, the cost of the lens implant, all supplies, follow-up for a one-year period, and all post-operative medical and optometric care. If additional laser or astigmatic surgery is required, an additional charge will be necessary. Because of the significant expenses associated with performing this type of surgery, including the number of staff and the surgical setting required, the cost to the patient is substantially more than corneal refractive procedures such as LASIK, PRK, LASEK and EPI-LASIK.
A summary note from Dr. Mandel
You are considering the implantation of a phakic IOL because you are very highly nearsighted and out of the range where corneal surgery would be as safe and effective. Alternatively, you have a moderate amount of nearsightedness, but because of the condition of your cornea, you are not a good candidate for corneal refractive surgery. The above information serves to answer some basic questions regarding the phakic IOL. It is designed to educate you so that you may formulate further questions for me and my staff, and to help you make a decision about undergoing surgery.
As you are aware, your eye is not perfect now and we cannot make the eye perfect. The purpose of the phakic IOL is to help improve your vision such that you are able to wear much thinner glasses or more easily tolerate low-power contact lenses, or (hopefully) enjoy excellent vision without the use of glasses or contact lenses for most tasks.
No surgeon can guarantee that you will have the result that you desire and/or that you will not incur complications from surgery. What I can guarantee is that I will perform the best possible surgery based on my years of experience as a cataract, cornea, and refractive surgeon. I will inform you of the pros and cons of the procedure, as well as the realistic expectations in your case, and fully delineate in writing the potential risks and complications of the procedure. Fortunately, although complications can occur, the FDA studies of both the AMO Verisyse lens and the Staar Visian lens have shown them both to be very effective and to have a very good safety profile – otherwise the FDA would not have approved the lenses.