Implantable Contact Lens (ICL)

...Implanted and Reversible

Millions of nearsighted Americans may be able to achieve quality vision thanks to the recent approval by the U.S. Food and Drug Administration of the Visian ICL™ Implantable Collamer Lens. This lens works like an implantable contact lens and is best suited for individuals who have moderate to severe nearsightedness.

“Many nearsighted patients previously not candidates for LASIK vision correction will benefit from the new Visian ICL” says Dr. David C. Brown, Medical Director and Founder of Eye Centers of Florida. “Thanks to the ICL, we can help individuals achieve vision they have always dreamed of having” he also adds. Click here to See Video.

Dr. Brown has played an active part in the development of the Implantable Collamer Lens (ICL) and has been performing this procedure in Europe, the Caribbean and in clinical trial studies since 1989. He is one of the first ophthalmologists in the country to perform this procedure in the US and one of just a few now performing it in the state of Florida.

Although this lens was just approved for use in the US, more than 40,000 Visian ICL’s have been implanted worldwide to date. The Visian ICL is a small foldable lens that is implanted through an incision so tiny that it closes without stitches. Due to the small incision, the procedure is minimally invasive and no corneal tissue is removed. This surgery is now being performed at Eye Centers of Florida’s SurgiCare Center in Fort Myers.

Once the lens is in place, it is designed to remain in the eye permanently. Unlike a regular contact lens, the Visian lens does not dry out or need to be cleaned. Best of all, should a patients needs change, it can be easily removed or replaced. As the lens does not attach to any structures within the eye, it will not move around after it has been implanted. Most patients typically do not feel any different but are amazed at the immediate improvement in their vision.

Nicola Tisdale of Port Charlotte had the procedure done two years ago as part of a clinical study program at Eye Centers of Florida. Originally, she wanted to have LASIK surgery but Dr. Brown felt that she was a better candidate for the ICL. “I was quite nearsighted and also had extremely dry eyes so I couldn’t wear contact lenses,” says Nicole. “I had worn glasses since the seventh grade and was so nearsighted I couldn’t see the clock next to my bed when I woke up”. “If my glasses weren’t where I had put them the night before, I wouldn’t be able to find them” she said smiling”!

Nicola now has excellent vision and hardly remembers the surgery other than waking up and being able to see without her glasses. “I just had a baby after getting my new implantable lenses and it was so terrific to wake up in the middle of the night to feed my baby and not to have to worry about finding my glasses,” says Nicola, age 35.

“Now I can go to theme parks, ride roller coasters and not worry about my glasses flying off,” she said. “I can now swim underwater and have been so thrilled that I’ve recommended them to my aunt who lives up north. I told her she should come down on vacation and see Dr. Brown” comments Nicola. “The staff was wonderful and I highly recommend my new lenses” she also added.

The Visian ICL is made of Collamer, a highly biocompatible material that contains pure collagen. According to the manufacturer, collamer is very stable, does not cause a reaction within the eye and filters out ultraviolet rays. Because Dr. Brown positions the lens behind the eye’s iris, it cannot be seen by the naked eye.

Eye Centers of Florida is the first provider of the new ICL in Southwest Florida and anticipates many patients will soon be wearing ICL’s. “I hear from my very nearsighted patients every day how exciting it would be to be free from glasses and contact lenses,” states Dr. Brown. “Many of these patients are not candidates for LASIK”, he added. “We are very excited about the new Visian ICL because it offers hope to our patients with impaired vision”.

What to Expect with the ICL procedure:

Step 1: A tiny incision is made under topical anesthesia.

Step 2: The lens is injected into the eye.

Step 3: The ICL gently unfolds and is
placed behind the iris.

Step 4: The ICL immediately after
placement.

Frequently Asked Questions:

1. What is an ICL?

ICL stands for Implantable Contact Lens. The ICL is designed to correct visual problems much the same way as an external contact lens. However, unlike an external contact lens the ICL is placed inside the eye behind the iris (colored part of the eye) and in front of the eye's natural crystalline lens.

2. For what type of person is the ICL most appropriate? Is this procedure for anyone who wears glasses or contacts?

Currently, STAAR Surgical, the developer of the ICL, is evaluating lenses designed to correct either near- or far-sightedness (also known as myopia or hyperopia). Eventually, the company will introduce new versions of both lenses that will also correct astigmatism. In clinical studies to date, patients have been enrolled with the ICL across all ranges of myopia and hyperopia. That is, patients with mild myopia or hyperopia have been treated as well as patients with moderate to severe myopia and hyperopia. Eventually, STAAR believes that the lenses will be approved for all levels of myopic and hyperopic correction. This can be compared to conventional or laser surgery techniques like RK or PRK which are designed only to address low levels of myopia and not hyperopia.

3. What are the patients' initial reactions to the ICL? Fears? Expectations? How does the ICL work?

STAAR's initial experience with the ICL is that patients with moderate to severe degrees of visual disablement are usually quite anxious to undergo a surgical procedure to correct their refractive problems. This is perhaps because spectacles are generally unsightly and uncomfortable and many patients cannot tolerate contact lenses. Further, because the ICL surgery is exceptionally similar to that which is employed 1.7 million times a year for cataract surgery, the patients are generally quite comfortable with the concept of an implantable lens to correct their refractive problems.

The ICL is implanted using a surgical technique that allows for an ultra-small incision in the eye, usually no more than 2.5mm, under topical anesthesia. This means the patient is completely awake and alert during the procedure with only a small amount of ocular drops applied to alleviate pain. This allows the surgeon to close the wound after ICL placement with no sutures and the lack of anesthesia allows the patient to have an almost immediate recovery of vision. In any case, the patient can usually obtain excellent vision as soon as the ocular dilation drops wear off (generally 4-24 hours).

4. How long does the implant procedure take?

The procedure to implant the ICL essentially involves making a micro-incision in the corneal periphery of the eye, instilling a viscoelastic agent to maintain shape of the globe, and then injecting the ICL. Because of the micro-incision employed, no sutures are required and the entire procedure should take anywhere from 5 to 15 minutes.

5. How long before the ICL takes affect?

Theoretically, the refractive effects of the ICL are immediate. However, because some patients have varying susceptibility to ocular dilation drops used during the surgery, they may find that a return to excellent vision is delayed until those drops wear off (4-24 hours). However, many patients report excellent uncorrected vision while still in the operating room.

6. When was the ICL approved by the FDA?

The Implantable Collamer Lens, sometimes referred to as the Implantable Contact Lens, was approved in late December 2005.

7. How many of these ICL procedures have been performed?

As of 1998, approximately 1000 surgeries, all performed outside of the United States, have been done using STAAR's ICL. Results with respect to predictability and safety have so far been excellent.

8. What kind of pain to the patient is involved?

Patient pain during the ICL procedure should be quite minimal. Prior to an incision being made in the eye, the patient is given topical anesthetic drops to numb the eye and might otherwise feel a small amount of pressure sensation during surgery. However, because of the micro-incision employed, postoperative pain should be nonexistent which can be compared to laser refractive procedures wherein significant post-op regiments of ocular pain-killing medications are required to alleviate otherwise substantial ocular discomfort.

9. What risks are involved with the ICL procedure during surgery and postoperatively?

As with any operative procedure, there are complications of surgery in general which could be related to anesthesia, drug reactions or other factors, which may involve other parts of the body. With regard to specific risks associated with the ICL surgery, the most likely potential complications would be premature cataract formation or corneal damage which could lead to reduced vision, infection which
could lead to loss of the eye or secondary glaucoma due to blockage of the pupil. However, STAAR has taken steps to ensure that the rate of occurrence of these complications is nonexistent, or at worst, minimal in the clinical studies.

10. How does the ICL compare to RK and PRK?

RK (Radial Keratotomy) and PRK (Photorefractive Keratectomy) are surgical procedures designed to change the spherical curvature of the cornea. While in some cases they can be quite effective for low to moderate myopia, neither procedure is effective at treating high myopia or hyperopia. Further, because they are dependent upon the variable healing response of the human cornea, predictability is not always acceptable. And, achievement of excellent visual results generally takes several weeks or months as hazing of the cornea dissipates and the eye stabilizes. Finally, both procedures are associated with substantial postoperative pain which can only be alleviated with significant postoperative regimens of steroidal painkillers.

The ICL on the other hand, is designed to address the full range of myopia and hyperopia. Since the lens is implanted inside the eye, using technology that is very similar to that used for cataract surgeries performed millions of times every year, variable healing responses are not an issue. This makes predictability of the ICL procedure superior to that of corneal refractive surgical procedures. That is, the technology employed to determine the appropriate power of the ICL to be implanted is identical to that used quite effectively by ophthalmologists performing cataract surgery everyday. Unlike corneal refractive procedures which require "touch-up" secondary surgical procedures to-fine tune the visual results, the immediate postoperative vision for the ICL patient should be equivalent to his/her long term postoperative vision. Since the ICL can be implanted through a minimally invasive surgical wound under topical anesthesia, patient rehabilitation and a return to excellent uncorrected vision is almost immediate, as compared to corneal refractive procedures which sometimes require weeks or months before a return to excellent vision.

Corneal refractive procedures such as RK and PRK impart a permanent change to the cornea to create a refractive effect. The ICL on the other hand simply involves the placement of a refractive lens within the patient's optical pathway. This means that if the surgeon miscalculates the appropriate ICL power, the lens could be removed and replaced with a new lens of an appropriate power with little or no detrimental effect on the eye.

11. Can both eyes be implanted with an ICL at once?

For myopes (nearsighted) the Implantable Contact Lens can be implanted in both eyes on the same day or it can be done on consecutive days. For hyperopes (farsighted) the ICL is still in clinical trials.

12. What does the procedure cost?

The cost of the ICL procedure to the patient at Eye centers of Florida is $3,000-3,100 per eye. The surgical fee includes all pre-op care for up to 6 months.

13. Does insurance reimburse the cost of the ICL procedure?

In some cases, yes. Insurance companies who currently reimburse PRK procedures would be anticipated to reimburse for the ICL procedure.

14. Are there any physical limitations to the patient following the ICL procedure?

STAAR anticipates no physical limitations on the patient subsequent to the ICL procedure. That is, the patient should be able to have a complete return to normal activity immediately following ICL implantation.

15. Are any other related surgical procedures required for the ICL?

Yes. Approximately one week prior to ICL implantation, two laser iridotomies will be made. This involves use of a non-invasive YAG laser to make two small incisions in the patient's iris (colored part of the eye) to ensure an adequate fluid pathway in the eye to prevent a buildup of intraocular pressure (secondary glaucoma) due to blockage of the pupil by the ICL.
These laser iridotomy procedures are routinely performed for various other reasons by ophthalmologists and are usually quite benign.

16. Is the ICL a permanent implant?

The ICL is designed to be placed in the patient's eye and remain there permanently or at least until the patient's natural crystalline lens develops a cataract through the normal aging process. Depending on the age of the patient at the time of ICL implantation this could be 20-30 years. However, with the exception of removing the ICL with the cataractous lens, which has developed due to old age, there should be no reason to ever remove an ICL.

17. Does receiving an ICL mean the patient will always be completely free of spectacles?

Not necessarily. Patients who required reading glasses or bifocals prior to implantation of the ICL-will likely continue to require some sort of vision correction for near vision. And younger patients who receive the ICL will still continue to require reading glasses once they reach middle age. The ICL is not designed to correct or alleviate natural aging of the crystalline lens which is first observed during middle age when patients begin to require bifocals or reading glasses. However, correction for residual myopic or hyperopic refractive problems should be minimal or nonexistent after placement of the ICL.

Are you a candidate for the Implantable Contact Lens?

If you’ve been considering LASIK - let us show you a better way to see
...even BETTER THAN LASIK.
While our LASIK technology remains the state-of-the-art treatment for low to moderate
nearsightedness, the new FDA-approved implantable contact lenses can provide a higher quality of vision for the highly nearsighted, with absolutely no removal of any precious cornea.

Call Eye Centers of Florida today for your *Free Evaluation 1.866.393.2345

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