ICL (Implantable Contact Lens): How this works.

Read: Columbus Dispatch 3/3/2006 -
Front page: "Quick Fix for Nearsightedness"

View: 10TV 5PM News 3/2/2006 -
Dr. Erdey is among the first in the U.S. to implant the ICL following FDA approval. His patient, Laurel Santino, MD, an Obstetrician practicing in Lancaster , is interviewed.

View: 10TV 11PM News 3/2/2006 -
Dr. Erdey's patient, Janet Knotts, relates her experience since receiving the ICL 8 years ago (1998), as part of the US FDA Study. 

Read: Review of Ophthalmology 2001 -
The Posterior-Chamber Implantable Contact Lens by Richard A. Erdey, M.D.

View: NBC4 News 1998 -
Dr. Erdey's patient, Lisa Carson, is the first in Ohio to receive myopia ICL in 1998

 


The Implantable Contact Lens (ICL™) is a lens made of a highly biocompatible Collamer® material that is permanently implanted into the eye, providing an alternative to glasses, contact lenses and Laser Vision Correction (PRK/LASIK) surgery. It is similar in design to implants inserted routinely during cataract surgery. The implant focuses light rays onto the retina resulting in clearer vision (How this works). It is the only minimally-invasive foldable lens of its kind approved for the U.S. market by the Food and Drug Administration. As a result of the unique foldable design, the ICL procedure allows an incision up to 50% smaller than competing technology, and its placement in the eye in front of the natural lens and behind the iris provides a more aesthetically pleasing outcome. (Click video clip above to play). This sutureless procedure is typically painless and visual rehabilitation is usually rapid.

Richard A. Erdey, MD has been an investigator for Staar Surgical’s Visian ICL™ U.S FDA Study since 1998. (View: NBC4 News – Dr. Erdey’s patient is first in Ohio to receive myopia ICL in 1998) His interest in the ICL continued to build throughout the approval process; it was driven by superior clinical outcomes, the stability and safety of the procedure and the high patient satisfaction rate. (Read: The Posterior-Chamber Implantable Contact Lens by Richard Erdey, M.D).

Gregory D. Searcy, MD
also maintains an active interest in this technology.

The ICL offers patients opportunities to achieve higher quality visual outcomes, particularly in those cases where laser vision correction is unsuitable because of moderate to severe myopia and / or corneas that are too thin to safely withstand laser reshaping.

STAAR Surgical's Visian ICL™ is approved for sale in 41 countries, including the European Union and Canada. It has successfully been implanted in more than 40,000 eyes worldwide.

Implantable Collamer Lens (ICL) FAQ’s :

· Who are the best candidates for the ICL?
· What are the U.S. FDA indications for the ICL?
· What will it accomplish?
· What preparation is required?
· Can both eyes be implanted with an ICL at once? If not, how long must I wait before surgery is performed on the second eye?
· Is the ICL better than Laser Vision Correction (PRK / LASIK)?
· Can the ICL dry out or become soiled or damaged like contact lenses?
· Can I feel the ICL once it is in place?
· If I receive an ICL will I always remain free of corrective lenses?
· What should I expect if I eventually require cataract surgery and I have an ICL?
· Are there risks to ICL implantation?



Who are the best candidates for the ICL?

People with thick glasses, excessively dry eyes, or corneas that are too thin or flat for LASIK are among the best candidates for the ICL. To determine if you are a suitable candidate, contact us to schedule a complimentary evaluation.

 
 
What are the U.S. FDA indications for the ICL?

The Visian ICL™ was U.S. FDA approved in December 2005. It 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) with less than or equal to 2.5D of astigmatism at the spectacle plane
· The reduction of myopia ranging from -15D to -20D with less than or equal to 2.5D astigmatism at the spectacle plane
· Adults 21 years of age or older with a stable refractive history within 0.5D for 1 year before implantation

The Visian ICL™ is not yet approved for patients with hyperopia. A toric version for patients with myopia and astigmatism is still in FDA trials; initial results are very promising!

 
 
What will it accomplish?

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.

 
 
What preparation is required?

Prior to placement of the Implantable Contact Lens, it is necessary to make two small holes in the colored portion of the eye (the iris) to ensure that intraocular fluid does not build up behind the iris or the ICL, resulting in secondary glaucoma.

 
 
Can both eyes be implanted with an ICL at once? If not, how long must I wait before surgery is performed on the second eye?

For safety, one eye is operated on at a time. Once you are comfortable with the visual results of the first eye (generally 1-4 weeks) then the second eye may be implanted with the ICL.

 
 
Is the ICL better than Laser Vision Correction (PRK / LASIK)?

In general an ICL is better suited in patients requiring correction of severe myopia (nearsightedness) because, it spares the excessive cornea flattening associated with LASIK. In these circumstances, it is not unusual for an ICL to provide better visual quality than LASIK. In fact, certain ICL-implanted patients are actually able to see better than they could with glasses or contacts. LASIK rarely provides such an optical benefit in this patient population.

Also, if a -10.0 D myope were treated with LASIK, about 40% of the cornea thickness must be removed by the excimer laser to achieve the corneal flattening required to neutralize the refractive error. Thinning and flattening the cornea this much may lead to night vision disturbances such as glare/haloes, degrade the sensitive optics of the eye in all lighting conditions, and potentially lead to a severe instability and distortion of the cornea called Keratoconus.
The ICL may also be preferable in older patients that may be expected to develop cataracts; the ICL can easily be removed should cataract surgery become necessary.
On the other hand, in younger, less nearsighted patients with corneas that are not too thin, Laser Vision Correction is preferred.


 
 
Can the ICL dry out or become soiled or damaged like a contact lens?

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.

 
 
Can I feel the ICL once it is in place?

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.

 
 
If I receive an ICL will I always remain free of corrective lenses?

After ICL implantation, glasses or contact lenses may be worn if necessary. Some people may still need glasses for night driving and other activities preformed in low light conditions even after ICL implantation. Some may benefit by having supplemental Laser Vision Correction to “fine tune” their result. The ICL does not help presbyopia--the need for reading glasses due to age. If a dramatic shift in the prescription occurs due to progressive cataract formation, the ICL can be removed and cataract surgery with lens implantation may be performed.

 
 
What should I expect if I eventually require cataract surgery and I have an ICL?

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 excellent results. However, the required implant power is sometimes difficult to predict, and the optics of this combination are typically not quite as good as the same theoretical patient who develops a cataract years after ICL implantation. In the latter case, the ICL is easily removed, the original corneal curvature is preserved and cataract surgery with an intraocular lens is implanted, yielding superior optical results.

 
 
Are there risks to ICL implantation?

No surgical procedure is risk-free. The proximity of the ICL to the iris and natural lens raises the possibility of late onset pigment dispersion syndrome or lens opacities (cataracts). Fortunately, both are rare. Lens opacities occurred in < 1% of patients in the FDA Study at three-year follow-up and are considered far easier to fix than corneal complications following LASIK surgery. 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).

 
 



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