The risks for Implantable Collamer Lenses (ICL's) compared to those of refractive surgery are pretty much the same - severely downplayed (but not really any different!). Note the different sources for ICL risks below saying pretty much the same things, and compare to the risks associated with LASIK:
Possible Risks ICL's
Potential Complications of the Visian ICL™ and Other Refractive Procedures
As with any type of surgery, the Visian ICL (Implantable Collamer® Lens) carries the risk of complications. To help educate prospective patients, the following information outlines some of the most common risks of the Visian ICL implant procedure and those of corneal refractive surgery. For detailed information regarding all possible complications, please ask your doctor.
•Complications Common among Refractive Procedures
•Complications with Corneal Surgery
•Visian ICL Complications
•Complications Common among Refractive Procedures
Refractive procedures, from LASIK surgery to implantable contact lens insertion, share possible complications.
Overcorrection and Undercorrection
The most common complications with any refractive procedure are overcorrection and undercorrection. A skilled surgeon will take meticulous measurements before surgery to determine the right amount of correction; however, these measurements are not always perfect. No matter the refractive procedure, undercorrection can be fixed with an additional procedure, which could include a second LASIK or PRK surgery or the removal and replacement of the Visian ICL. Continued use of glasses or contact lenses is also a possibility.
Because all of these procedures involve some form of manipulation (no matter how slight), there is a risk of an infection. Although it is not a common complication, it is important to realize that an eye infection may range from delaying the healing of the eye to serious damage, including possible loss of visual acuity.
Halos and Night Glare
The most common side effects of corneal refractive surgery are halos and glare around lights at night. These problems range in severity from being barely noticeable to severely limiting a person's visual acuity. In many cases, severe halos and night glare can be reduced with a second surgery, but it is often difficult to eliminate these effects completely.
Loss of Visual Acuity
Although extremely rare, there is the possibility that a refractive procedure can cause damage to the eye including loss of visual acuity.
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Complications with Corneal Surgery
Corneal surgery, including LASIK and PRK, requires that a small portion of the cornea be removed to change the shape and focusing ability of the eye.
There is increasing concern in the ophthalmic community regarding dry eye and the decision to perform LASIK. Dry eye is a common disease that often causes patients to seek LASIK because of difficulty wearing contact lenses. According to Toda, et al, in the August 2002 Archives of Ophthalmology, “more than 75 percent of the patients undergoing LASIK have preoperative dry eye.” 1
Additionally, some 59.4 percent of those patients who do not have dry eye preoperatively will end up with it postoperatively2. There is also general consensus that worsening of preexisting dry eye occurs after LASIK.
Problems with the Corneal Flap
Some of the complications of LASIK eye surgery stem from the corneal flap. It may be too thin or too thick or sometimes irregular. Diffuse lamellar keratitis, or DLK, describes another flap-related problem that develops when epithelial cells migrate beneath the flap. These complications are not associated with the Visian ICL surgery as the cornea remains untouched.
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Visian ICL Complications
Some complications associated with the Visian ICL differ from those associated with LASIK or PRK. For a complete discussion of all complications, please ask your ophthalmologist.
Damage to the Crystalline Lens
Since the Visian ICL is placed inside the eye, potential risk touching the eye's natural lens may result. Damage to the natural lens may cause an opacity of the lens, in the most serious case, requiring removal and replacement of the natural lens with a synthetic lens. These opacities, requiring surgical intervention, occurred in less than 1 percent of the Visian ICL patients3.
Complications of Iridotomy
One to two weeks prior to the implantation of the Visian ICL, the surgeon will perform a procedure called an iridotomy. Using a YAG-laser, the doctor will make one or two small openings near the edge of your iris. Complications from the iridotomy are rare, but could possibly include natural lens or corneal damage, inflammation, temporary increase in intraocular pressure, bleeding, and scar formation.
Increase in Eye Pressure
In some cases, there may be an increase in eye pressure. If this occurs, a surgeon may quickly remedy the problem with additional medications or surgical intervention.
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Advantages over Laser Refractive Surgery
Many patients who compare the side effects of laser refractive eye surgery and implantable contact lens complications decide that the benefits of the Visian ICL far outweigh the rare risks associated with it. Because implantation of the lens does not physically change any part of the cornea or other part of the eye, side effects such as halos and glare are almost nonexistent. Also, should any problems with the lens arise, the Visian ICL is completely removable. Learn more about the advantages of our phakic IOL.
If you are interested in undergoing the Visian ICL procedure, find a qualified Visian ICL Surgeon in your area who can discuss the risks and benefits as they pertain to your individual medical history and goals. To learn more about the clinical trials that assessed the safety of the Visian ICL, Contact STAAR® Surgical Company today.
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1. Toda I, Asano-Kato N, Hori-Komai Y, Tsubota K. Laser-Assisted In Situ Keratomileusis for Patients With Dry Eye. Archives of Ophthalmology. 2002;120(8):1024-1028
2. Yu E, Leung A, Rao S, Lam DSC. Effect of laser in situ keratomileusis on tear stability. Ophthalmology, 2000; 107:2131-2135
3. ICL in Treatment of Myopia (ITM) Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia. Ophthalmology. 2004;111:1683-1692
Implantable Contact Lens Risks
When considering refractive surgery of any kind, you should be aware of each procedure's possible complications. Potential ICL risks include:
Overcorrection – This complication occurs if the prescriptive power of the implanted ICL is too strong. In most cases it can be corrected with corrective eyewear or with an ICL replacement.
Undercorrection – The opposite of overcorrection, undercorrection is the result of an implantable contact lens with too weak of a prescription. Correction methods are similar to those of overcorrection.
Infection – During most surgeries, there is a potential of an infection. Severe infection during ICL implantation is rare.
Increased intraocular pressure – Pressure may build in the eye after an ICL procedure. The sooner a surgeon is alerted to this complication, the greater the chance of avoiding serious damage.
Repositioning or removal of lens –ICLs have the potential, however slight, of needing to be repositioned. The frequency of this complication may vary by implantable contact lens models.
Damage to crystalline lens – Because implantable contact lenses are implanted into the eye, there is a potential that the eye's natural lens may be damaged during the procedure. If the damage is severe, the crystalline lens may need to be replaced with an intraocular lens.
Cataract development – Over 50 percent of the population will develop cataracts by the age of 65, however, it is believed that the use of some implantable contact lenses may cause cataracts at an earlier age.
Halos, glare, and double vision – Updated ICL models greatly diminish the risks of halos, glare, and double vision.
Retinal detachment – Less than 1 percent of patients in the clinical studies for both the Verisyse™ phakic IOL and the Visian ICL™ were affected by retinal detachment. It should be noted, however, that the occurrence of retinal detachment increased as the degree of myopia increased.
Vision loss – Extremely rare, there is a possibility of vision loss from this refractive procedure. Typically the loss of visual acuity is due to bleeding, severe inflammation, or an untreated infection.
It is important to note that several of the ICL risks listed above are potential complications of all refractive procedures, including:
Risks of Lens Implantation
As with any surgical procedure, complications are rare but can occur after implantation of phakic IOLs.
The FDA warns of other potential complications such as sometimes severe vision loss. Problems also can develop with night driving and may include halos, increased eye pressure (intraocular pressure) that can damage the eye's optic nerve and inadequate lens power that may not properly correct vision. After surgery, your doctor will continue monitoring your endothelial cell counts, an indicator of how healthy your corneas are and how well they heal afterward.
At the 2006 Joint Meeting of the American Academy of Ophthalmology (AAO) and Asia Pacific Academy of Ophthalmology, a researcher said that — when comparing studies of the Verisyse and Visian ICL — the following complication rates were noted:
|Acute glaucoma||1.6 percent||0.19 percent|
|Endothelial cell loss||6.6 percent||5.0 percent|
|Cataracts||9.8 percent||1.8 percent|
|Retinal detachment||1.47 percent||0.46 percent|
|Notes: Buratto L. "Phakic IOLs: which approaches are likely to be effective and safe?" Program and abstracts of the 2006 Joint Meeting of the American Academy of Ophthalmology and Asia Pacific Academy of Ophthalmology; November 11-14, 2006; Las Vegas, Nevada. Refractive Surgery Subspecialty Day.|
In Visian ICL studies performed after approval, patients had lower rates of glaucoma and endothelial cell loss and higher rates of retinal detachment and cataracts, compared with clinical trials.
All complication rates were lower for the Verisyse in studies conducted after initial FDA approval.
Because phakic IOLs are a relatively new technology, long-term effects and potential risks of lens implantation are unknown.
I WHAT ARE THE RISKS?
As with any refractive surgical procedure, there are certain risks and complications associated with the INTACS procedure. These risks include infection, shallow placement of the INTACS inserts into the tunnel, deposits in the tunnel where the INTACS inserts are placed, haze in the incision area, visual symptoms (including discomfort, burning, itching, tearing, double vision, increased sensitivity to light, glare and halos around lights, fluctuating vision, and reduced vision at night), shallow segment placement, a non-infectious healing response and developing blood vessels in the cornea. It is important to discuss these risks with your doctor before you make the decision to have your surgery. If the results of your INTACS procedure are not satisfactory, you may need to have
the INTACS inserts removed or replaced. If your INTACS inserts are removed, you may need to have a corneal transplant procedure. The long-term safety risks of using INTACS inserts in the keratoconus population are unknown. There may be other risks associated with INTACS inserts that cannot be foreseen at this time.
Other Possible Complications: Other possible risks include corneal ulcer formation; endothelial cell loss (loss of cell density in the inner layer of the cornea, possibly resulting in corneal swelling); ptosis (droopy eyelid); corneal swelling; retinal detachment and hemorrhaging. Complications could also develop that require further corrective procedures including either a partial (lamellar) or full-thickness corneal transplant using donor cornea. These complications include loss of corneal disc; damage to the corneal disc; disc decentration; progressive corneal thinning (ectasia). Sutures may also be required, which could induce astigmatism. It is also possible that the instrument that creates the tunnel goes too deep and passes through the back of the cornea and enters the anterior chamber of the eye which may require suturing. This would preclude inserting the INTACS inserts until the eye healed. It is also possible the instrument could create a tunnel that was too shallow and exit the front of the cornea, which may preclude inserting the INTACS inserts until the eye healed. There are also potential complications due to anesthesia and medications that may involve other parts of your body. Since it is impossible to state all potential risks of any surgery or procedure, this Informed Consent form does not provide a comprehensive listing of every conceivable problem that you may encounter.
Employment Risk: You should be aware that having this surgery may affect future employment opportunities with certain military or law enforcement agencies.
Later-Discovered Complications: The INTACS procedure is a relatively new technique. You should be aware that other complications might occur that have not yet been reported. Longer-term results may reveal additional risks and complications. After the procedure, you should continue to have routine check-ups to assess the condition of your eyes. INTACS inserts may not prevent the need for corneal transplant at some point in the future. It is unknown how INTACS inserts will affect the course of your keratoconus. This is why it is important we continue long-term follow-up on you, either in our clinic or through other health care providers, if you live far away.
Risks of Not Undergoing the INTACS Procedure: The risks of not having the surgery are limited to those associated with your current visual condition. These include but are not limited to the dangers that may be associated with losing your glasses or contact lenses, the risks of corneal distortion and/or infection from wearing contact lenses, and the risks of trauma to the eye caused by breakage of glasses or contact lenses in the eye.
Although no procedure is risk free, the risks of serious damage to the eye from ICR surgery are minimal and include the possibility of infection introduced at the time of surgery, surface cells of the eye (epithelium) growing into the tracks where the rings have been implanted requiring removal of the ring, and the remote possibility of permanent damage to the cornea or the inside of the eye. Any surgery on the eye can result in a permanent decrease or loss of vision. Fortunately, severe complications are exceedingly low. Side effects of the ICR include glare, halos, difficulty with vision at night, and fluctuation of vision throughout the day.
Even if a complication does not occur, as with all surgical refractive procedures, patients may not be 100% satisfied with the result and/or may require the use of glasses to "fine tune" the vision for distance tasks such as driving by day or night. Additionally, if monovision is not performed, patients over 40 having both eyes corrected for distance will require reading glasses just as they would if they had not had surgery but continued to wear contact lenses.
If for any reason a patient is not satisfied with the vision following implantation of the ring segments, they can be removed. In almost all cases the eye is returned to (or very close to) its original refraction (amount of nearsightedness). In some cases following removal, the amount of nearsightedness and/or astigmatism is not identical to pre-operative levels and a new spectacle (or contact lens) prescription is required. In some cases following removal, the amount of nearsightedness and/or astigmatism is slightly more or slightly less than pre-operative levels. In some cases following removal of the segments there will be a small amount of astigmatism (curvature of the cornea) actually induced by the surgery where none had existed before the surgery.