The Advantages of Visian ICL

There are many unique advantages of STAAR® Surgical Company's Visian ICL™. For years, the only method of permanent vision correction that didn't involve glasses or contact lenses was corrective laser eye surgery. With the advent of the Visian ICL, however, that's all changed. Now, you can enjoy "High Definition Visian™" – vision correction that's sharper, clearer, more vivid, and has greater depth and dimension – in a simple, 15-minute outpatient procedure. Read on for more information why the Visian ICL could be the best vision correction procedure for you!

High Definition Visian™
Quality of Vision Excellence – High Definition Visian™ The Visian ICL offers vision correction that's sharper, clearer, more vivid, and has greater depth and dimension than other procedures. The main advantage of the Visian ICL over traditional corrective laser eye surgery is that patients may experience significant improvement in quality of vision after the lens is implanted 1. When compared to the results of corneal refractive surgery, the Visian ICL may produce superior vision quality as evidenced by fewer higher order aberrations 2. Patients experience a nearly immediate visual recovery and "Wow!" results.

Technologically Advanced Lens Material
Unlike other phakic IOLs, the Visian ICL is made from Collamer, a technologically advanced lens material exclusive to STAAR Surgical Company. Because of the collagen base in Collamer, it is biocompatible with the eye and may provide superior optical performance 3. Learn more about the composition and advantages of Collamer.

Exceptional Patient Experience
Simple, Safe & Invisible Lens
Because the Visian ICL is implanted in the posterior chamber, behind the iris, unlike other phakic IOLs, the lens is invisible to both the patient and any observer. Also, its positioning in the eye maintains normal iris function, promotes stability, and may reduce potential complications. The entire lens insertion procedure can take as little as 15 minutes!

The "Wow" Factor
After the simple 15-minute outpatient procedure, patients experience an immediate improvement in vision quality and are "Wowed" by the results. In fact, the quality of vision achieved is many times better than any previous vision correction solution.

Comfort From The Start
Short Recovery Time
The recovery time for the Visian ICL is very quick and comfortable, and may be as little as a day, due to the very small size of the incision required. The incision needed to implant the foldable Visian ICL is tiny and located on the far edge of the cornea, where there is little danger of it interfering with vision. Once the lens is implanted, sutures are typically not needed to close the incision, further simplifying the procedure. Read more about the safety of the Visian ICL.

Reduced Risk of Complications
Patients undergoing corneal refractive procedures, such as LASIK and PRK, may be susceptible to side effects associated with corneal surgery including dry eye and thinning of the cornea. The LASIK procedure involves removal of tissue from the cornea, which means some of its complications may be more difficult to correct than the possible complications of the Visian ICL. All surgical procedures carry some risk; however, the side effects or complications related to the Visian ICL, in most cases, can be corrected by your own surgeon.

Solution For Life
Removable
One of the most common concerns that people have about corrective laser eye surgery is that the procedure permanently changes the eye, and what will happen if a complication arises. One of the important advantages of the Visian ICL is that while it can permanently correct your vision, in the unlikely event that an ICL patient experiences negative side effects after surgery, the lens can be removed and/or replaced if necessary. Also, concerns involving the cornea typically do not apply to the Visian ICL, as no natural tissue is removed or changed (reshaped) in any way during implantation.

Unique UV Blocking
Long-term exposure to UV radiation can damage the eyes; and longer term or more intense exposure increases the chance of eye disorders including the development of cataracts and some retinal problems. As an added feature, the Visian ICL advanced lens material contains a UV blocker that actually prevents harmful UVA and UVB rays from entering the eye, possibly preventing the development of UV related eye disorders.

Patient Preferred Technology Proven Track Record
Over 15 years of research and development has made the Visian ICL a leader in phakic IOL technology. There have been over 200,000 Visian ICL implants performed worldwide. And when asked about the procedure, over 99% of the patients were highly satisfied.

Wide Treatment Range
The Visian ICL has proven to be effective in patients within a wide range of refractive errors both Myopic and Hyperopic. In fact, the Visian ICL can correct a large range of refractive errors between +10 to – 18 with or without astigmatism of up to 6 Dioptres and including mixed astigmatism. Before now, some of these individuals were not candidates for surgical eye correction but with Visian ICL they are now correctable. Clinical studies have shown how the Visian ICL is truly a breakthrough myopia treatment in terms of vision correction results. Because implantation of the phakic IOL does not require any structural alteration of the eye, results are predictable and very stable 3. Read more about the results of ICL corrective eye surgery.

Now that you have read about some of the advantages of the Visian ICL, you may wish to learn more about its use as an alternative to corrective laser eye surgery; contact STAAR Surgical Company for clinical trial results and more. To find out if you are a good candidate for the phakic IOL, find a qualified Visian ICL surgeon near you who is qualified to perform the Visian ICL procedure.

1. Sarver EJ, Sanders DR, Vukich, JA. Image quality in myopic eyes corrected with laser in situ keratomileusis and phakic intraocular lens. J Refract Surg. 2003;19(4):397-404.

2. Martin RG, Sanders DR. Higher order aberrations following implantation of four foldable lens designs. Presented at: American Society of Cataract and Refractive Surgery (ASCRS); June 21-26, 2003; New Orleans, La.

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

Clinical Results

Data from research, reviewed and approved by the FDA, show that corrective eye surgery using the Visian ICL is safe and effective for the correction or treatment of myopia. It also shows that the Visian ICL has distinct advantages over refractive surgical procedures such as PRK and LASIK, and has a lower chance of resulting in unwanted visual distortions (called “higher order aberrations”) compared to LASIK.

Clinical Trial of Visian ICL for Moderate to High Myopia: Three-Year Follow-Up In the 2004 ICL clinical trial three-year follow-up reviewed by the FDA "support the safety, efficacy, and predictability of Visian ICL surgery to treat moderate to high myopic errors."

The three-year data, based on the assessment of 526 eyes of 294 patients, also produced the following refractive results:

• 99 percent of patients were satisfied/very satisfied with their results.
• 98.3 percent of patients had uncorrected visual acuity of 20/40 or better.
• Once vision was corrected, the correction was stable and did not change over the follow up period.
• Additionally, the incidence of glare, halos, double vision, night vision problems, and night driving difficulties remained unchanged from before surgery.

Comparison of ICL and LASIK for Moderate to High Myopia

Visual acuity, or the vision readable at a particular distance, is not an accurate measurement of visual quality. While two individuals may see 20/20 (visual acuity), each individual's quality of vision may differ. This “quality of vision” was quantified and studied in the article authored by Edwin T. Sarver, PhD et al.

A comparison of higher order aberrations, or distortions, in vision that may result from vision correction surgery, were objectively measured following LASIK and Visian ICL surgery. The results were then calculated and simulated retinal images (what the patient would see) were compared.

A study entitled Comparison of Implantable Contact Lens and Laser Assisted in Situ Keratomileusis for Moderate to High Myopia conducted by the Center for Clinical Research features a two-year clinical study comparing the results of ICL and LASIK corrective eye surgery. It reports the following:

The Visian ICL creates favorable outcomes in stability and provides high-quality vision even to those patients requiring high corrections.

The Visian ICL has some advantages over LASIK; the patient’s pupil size is less important and a patient doesn’t need to have thick corneas to successfully undergo myopia treatment with the Visian ICL.

Since the Visian ICL allows for corrective eye surgery with no permanent structural change to the cornea, it can be removed if the patient dislikes the results – an option not available to LASIK patients.

The discussion in the report states that the "dramatic improvement of the ICL over the LASIK procedure is not unexpected since it is more accurate to manufacture the exact correction with a lens implant than to ablate the correction onto the corneal tissue, which is then subject to corneal healing. This is especially dramatic in view of the fact that 23% of the LASIK cases required enhancement surgery compared with only 4.3% in the ICL cases… The ICL offers the moderate to highly myopic patient a viable alternative to corneal laser refractive surgery.

VISIAN ICL Myopia Treatment

As studies show, corrective eye surgery with the Visian ICL presents a low risk of complications, predictable outcomes, excellent vision correction, and a low incidence of high-order aberrations – lower than currently offered by refractive surgical procedures such as LASIK. The Visian ICL has some advantages over PRK and LASIK corrective laser eye surgery, and can improve the vision of those who may not be good LASIK candidates. Professionals wishing to learn more about the Visian ICL clinical results in patients with mild, moderate, or severe myopia should contact STAAR® Surgical Company.

1. 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

2. Sarver EJ, Sanders DR, Vukich, JA. Image quality in myopic eyes corrected with laser in situ keratomileusis and phakic intraocular lens. J Refract Surg. 2003;19(4):397-404.

3. Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. J. Cornea Ext Dis, 2003;22(4):324-331.

Quick comparisons to help you evaluate your vision correction options and to see if the Visian ICL might be right for you.

There is always some degree of risk associated with any surgery, and refractive procedures are no different. Both corneal refractive surgery (LASIK and PRK, for example) and the implantation of lenses like the Visian ICL have individual and shared features and risks. For example, LASIK and PRK share complications like dry eyes, but only LASIK has the risk of corneal flap complication. Similarly, Visian ICL and the other phakic intraocular lens are each implanted into the eye, but each has a different lens placement. Below, the similarities and differences of refractive procedures are outlined.

• Similarities of All Refractive Procedures
• Corneal Refractive Surgery: LASIK and PRK
• Comparison of Phakic IOLs
• Learn More about the Visian ICL

Similarities of All Refractive Procedures
All refractive procedures are designed to improve some degree of "refractive error," which may include nearsightedness, farsightedness, or astigmatism. In addition to sharing the common goal of vision improvement, the procedures also share possible risks.

Some possible complications shared by all refractive procedures include:

• Overcorrection
• Undercorrection
• Infection
• A degree of residual refractive error

Corneal Refractive Surgery: LASIK and PRK
Both LASIK and PRK are laser eye surgeries used to correct myopia (nearsightedness), hyperopia (farsightedness), and astigmatism by reshaping the cornea. In doing so, sensitive eye tissue is surgically removed. Because of the similarity between the procedures, PRK and LASIK share additional possible complications.

Some shared possible LASIK and PRK complications include:

• Post-PRK or LASIK dry eyes
• Glare and halos surrounding lights (especially at night)
• Difficulty seeing in low-light situations

PRK Complications
In addition to the shared risks listed above, there are other possible PRK complications.

Delayed Healing
Because PRK surgery requires that the outer layer of the cornea be removed during the procedure, there is an increased healing time for the eye. The recovery during the first few days after surgery may be more painful than LASIK recovery, due to the removal of the epithelial cells.

Other Complications
Additional PRK complications include an increased sensitivity to light and the development of corneal haze. Corneal haze is a gray-white opacity that develops where the cornea was reshaped. In most cases, the haze will disappear within nine months; however, some occurrences of corneal haze do not disappear.

LASIK Complications
Although LASIK has a quicker recovery time than PRK, it has additional complications. Unfortunately, LASIK complications like corneal flap errors, diffuse lamellar keratitis, and ectasia can be quite serious and may be difficult to correct.

Corneal Flap Complications
There are several LASIK complications involving the corneal flap, including an incorrectly cut flap, failure of the flap to adhere correctly, and a wrinkle developing in the flap. These flap-related LASIK complications can cause irregular astigmatism leading to distorted vision. These LASIK complications can occur in both traditional LASIK and INTRALASE® procedures, although studies show a lower occurrence of flap complications when LASIK is performed with the INTRALASE laser.

Diffuse Lamellar Keratitis
Diffuse lamellar keratitis (DLK) is a serious possible LASIK complication. DLK, which can occur in both traditional and INTRALASE procedures, involves cells getting under the corneal flap. As a reaction to the foreign material, the eye becomes inflamed and begins to scar. Without prompt treatment, DLK can cause permanent vision loss.

Ectasia
Probably the most serious LASIK complication, corneal ectasia is the progressive thinning of the cornea that may lead to the need for a corneal transplant. Although rare, as the length of time since LASIK was first introduced grows, there is an increase in the number of LASIK patients who have developed ectasia. New patient criteria may curb some ectasia occurrences by screening out people now deemed inappropriate for LASIK surgery. Ectasia is primarily a LASIK complication, however, in rare occasions, it may also occur with PRK.

Comparison of Leading "Phakic IOLs"
The Visian ICL and the Verisyse (Artisan) P-IOL are both "phakic IOLs" (intraocular lenses) approved by the FDA for vision correction. View the potential risks and complications of the phakic IOLs.

Both phakic intraocular lens implants:

• Correct vision by complementing the eye's natural lens rather than replacing it.
• Are able to correct or reduce a broader range of nearsightedness than LASIK, including severe myopia (up to -20 diopters of nearsightedness).
• Are referred to as implantable contact lenses (ICLs).
• Are removable if necessary.
• Contain an ultraviolet blocker.

Difference Between the Visian ICL and Verisyse (Artisan) P-IOL
Although the Visian ICL and the Verisyse (Artisan) phakic intraocular lens share some characteristics, there are several notable distinctions between them. These differences include:

• Lens placement - The Verisyse (Artisan) P-IOL clips onto the iris and is visible to everyone, while the Visian ICL is placed in the posterior chamber making it invisible to the naked eye.
• Lens material - The Visian ICL is made from Collamer; Verisyse (Artisan) P-IOL is made from a plastic called polymethylmethacrylate (PMMA). Collamer is found only in STAAR products, including the Visian ICL. Because it contains collagen, a protein found naturally in the human body, Collamer it is uniquely biocompatible. In addition, Collamer possesses a unique feature; a UV blocker that provides a lifetime of protection.
• Flexibility - The Visian ICL is made of a soft foldable material and can inserted into the eye through a micro self sealing incision. The Verisyse (Artisan) lens is made out of a rigid plastic material and can only be implanted through a much larger incision. A smaller incision size is preferable because it is less likely to induce astigmatism and results in faster wound healing.
• Procedure time - The Visian ICL procedure is a short outpatient treatment that can be completed within 15 minutes. The Verisyse (Artisan) procedure requires a longer surgery time due to the need to suture the larger incision required for the implantation of this rigid non foldable lens.
• Treatment range -The Visian ICL offers treatment of a wider range of myopia (-3.0D to -20.0D).

See how the Visian ICL compares to LASIK and PRK

To learn more about the various refractive procedures, including the Visian ICL, meet with a qualified Visian ICL surgeon or contact STAAR Surgical Company today.

Visian ICL Vs LASIK and PRK

Deciding on the vision correction procedure that's right for you is an important one. Let the table below show you how the different options compare and ask your eye care professional about the details.

Quality of Vision Visian ICL LASIK PRK High definition vision Excellent Good Good Clarity of vision Excellent Good Good Contrast Excellent Good Good Night vision Excellent (1) 24% reported a reduction (2) Over 16% reported a reduction (3) Predictable outcomes Highly predictable (1) Less predictable with higher vision correction (4) Less predictable with higher vision correction (5) Patient Experience Visian ICL LASIK PRK Outpatient procedure Yes Yes Yes 15-20 minute surgery Yes Yes Yes Local anesthesia Yes Yes Yes Minimally invasive Yes, 3 mm opening Yes, 7-9.5mm corneal flap Yes The “Wow” of immediate visual acuity Yes Yes Blurry fluctuating vision up to 3 months 1-2 day short recovery time Yes Yes, with additional 1-2 weeks for “flap” healing Delayed visual recovery up to 4 wks. Contributes to “Dry Eye” No Yes, over 29% report some occurence (3) Yes, occurences during the recovery period Future Vision Versatility Visian ICL LASIK PRK Removable Yes No, corneal tissue cannot be replaced No, corneal tissue cannot be replaced Vision correction flexibility Yes, removability does not limit future treatment options Limited if additional treatments involve the cornea Limited if additional treatments involve the cornea UV protection Yes, blocks 100% of harmful UVA and UVB light (6) No No Patient Types Visian ICL LASIK PRK Mild to moderate nearsightedness Yes Yes Yes High nearsightedness Yes Limited by corneal thickness and pupil size Limited by corneal thickness and pupil size Thin cornea Yes Limited range of nearsighted correction Limited range of nearsighted correction Large pupil Yes Greater chance of increased unwanted aberrations Greater chance of increased unwanted aberrations

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References
1. UV-absorbing collamer implantable contact lens (ICL) for the correction of myopia. PMA #P030016. Presentation to the Ophthalmic Devices Advisory Panel. October 3, 2003.
2. Hill JC. An informal satisfaction survey of 200 patients after laser in situ keratomileusis. J Cataract Refract Surg. Jul-Aug 2002;18(4):454-459.
3. Jabbur NS, Sakatani K, O'Brien TP. Survey of complica- tions and recommendations for management in dissatisfied patients seeking a consultation after refractive surgery. J Cataract Refract Surg. Sept 2004;30(9):1867-1874.
4. Dan Z Reinstein, Jonathan D Carr, William B Threlfall, Randall Cook, Emma Cremonesi, Hugo FS Futton. Multi-center LASIK outcomes in myopia using the Technolas 217C in over 20,000 eyes. ASCRS 2001 Submissions. April 2001:2.
5. Rajan MS, Jaycock P, O'Brart D, Nystrom HH, Marshall J. A long-term study of photorefractive keratectomy; 12-year follow-up. Available at www.ncbi.nlm.nih.gov/sites/entrez . Accessed May 2008
6. Data on file: STAAR Surgical Company. ©2008 STAAR® Surgical Company 10-0004-35

Frequently Asked Questions about the Visian ICL™

To help you determine whether you might be a good Visian ICL candidate, STAAR® Surgical Company has provided useful Visian ICL information, including the answers to the following frequently asked questions:

How do I know if I’m a suitable Visian ICL candidate?

Candidates for the Visian ICL are between 21 and 45 years of age, suffer from myopia(nearsightedness) or Hyperopia (longsightedness) ,and want to experience superior vision correction. The ideal Visian ICL candidate has not undergone any ophthalmic surgery and does not have a history of eye disease such as iritis, glaucoma, or diabetic retinopathy.

Anyone seeking clearer vision may be a Visian ICL candidate, including those with special or extreme vision correction needs. Consumers should contact a qualified Visian ICL surgeon for more information, including an assessment of their candidacy.

Without a enough anterior chamber depth or endothelial cell density may not be a good Visian ICL candidate.

Where is the Visian ICL placed?

A qualified ophthalmologist will insert the Visian ICL through a small micro-opening, placing it inside the eye just behind the iris in front of the eye's natural lens. The Visian ICL is designed to stay in position with no special care. Learn more about the Visian ICL surgery procedure.

What is the track record of the Visian ICL?

Prior to being placed on the market, the Visian ICL was subject to extensive research and development. Today, more than 40,000 people worldwide enjoy the benefits of the device. In US clinical study, over 99 percent of patients were satisfied with their implant. The Visian ICL has a track record of stable, consistently excellent clinical outcomes. The lens has been available internationally for over 15 years. More Visian ICL information is detailed on our corrective surgery clinical resultspage.

Does it hurt?

No, most patients state that they are very comfortable throughout the procedure. Your ophthalmologist will use topical anesthetic drops prior to the procedure and may choose to administer a light sedative as well.

What is the Visian ICL made of?

The Visian ICL is made of Collamer®, a highly biocompatible advanced lens material which contains a small amount of purified collagen. Collamer does not cause a reaction inside the eye and it contains an ultraviolet blocker that provides protection to the eye. Collamer is a material proprietary to STAAR Surgical Company.

What if my vision changes after I receive the Visian ICL?

One advantage of the Visian ICL is that it offers treatment flexibility. If your vision changes dramatically after receiving the implant, your surgeon can remove and replace it. If necessary, another procedure can be performed at any time.

Patients can wear glasses or contact lenses as needed following treatment with the Visian ICL. The implant does not treat presbyopia (difficulty with reading in people 40 and older), but you can use reading glasses as needed after receiving the Visian ICL.

What type of procedure is involved in implanting the Visian ICL?

The surgical procedure to implant the Visian ICL is simple and painless. As a Visian ICL candidate, your surgeon will prepare your eyes one to two weeks prior to the procedure by using a laser to create two very small openings in the colored part of your eye which lies between the lens and the front chamber of your eye. This allows for the natural passage of fluids between the two areas, thereby avoiding the build up of intraocular pressure following the treatment.

The implantation procedure itself takes about 15 minutes and is performed on an outpatient basis, though you will have to make arrangements for someone to drive you to and from the procedure.

You can expect to experience very little discomfort during the Visian ICL implantation. You will undergo treatment while under a light topical or local anesthetic, perhaps with the addition of a mild sedative. Following surgery, you may use prescription eye drops or oral medication. The day after surgery, you will return to your surgeon for a follow-up visit. You will also have follow-up visits one month and six months following the procedure.

Can the Visian ICL be removed from my eye?

Although the Visian ICL is intended to remain in place permanently, a qualified ophthalmologist can remove the implant if necessary.

Is the Visian ICL visible to others?

No. The Visian ICL is positioned behind the iris (the colored part of the eye), where it is invisible to both you and observers. Only your surgeon will be able to tell that vision correction has taken place.

Will I be able to feel the Visian ICL once it’s in place?

The Visian ICL is designed to be completely unobtrusive after it is put in place. It stays in position by itself and does not interact with any of the eye’s structures.

Where can I get further information about the Visian ICL?

If you are a potential Visian ICL candidate who is interested in obtaining further Visian ICL information, you should contact a qualified Visian ICL surgeon . Physicians should contact STAAR Surgical Company, the maker of the Visian ICL, to learn more.