AMO VERISYSE Phakic Lens Implant:

Harvard Eye Associates — 30 Years of Lens Implant Experience!

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Frequently Asked Questions:

The information here is provided to help you decide whether to undergo implantation of the Verisyse phakic lens implant for the correction of your nearsightedness (myopia). Please read this information carefully and discuss it with our ophthalmologist during your initial consultation at Harvard Eye.

Our eye surgeons can determine if you are a suitable candidate for the Verisyse Phakic IOL. However, you are the only person who can decide whether the surgery is right for you. Make sure that all of your questions have been answered to your satisfaction before deciding to proceed with lens implant surgery. If anything is not clear to you, the staff at Harvard Eye is available to provide further guidance. Our goal is always to offer the latest advancements and the highest quality of eye care to you and your loved ones.

An IOL is not required to correct nearsightedness. For instance, you may be able to wear glasses or contact lenses instead to correct your vision. Depending on the degree of your nearsightedness and other conditions of your eye, there may also be different refractive surgery options available to correct your vision including Laser Assisted In-Situ Keratomileusis (LASIK).

What Are Implantable Contact Lenses?

Implantable contact lenses, or phakic intraocular lenses (IOLs), are lens implants that work in the eye along with your existing natural lens to correct myopia (nearsightedness). Because the Verisyse implantable contact lens can correct a wider range of myopia than laser refractive procedures, it is often an excellent alternative to LASIK surgery.

What Is The Meaning Of "Phakic"?

Verisyse implantable contact lenses are often referred to as "phakic IOLs", which may cause some confusion when trying to distinguish between the Verisyse lens and another IOL. The term "phakic" refers to your natural lens being in place inside your eye. (The natural lens is also called the crystalline lens.) An eye care professional would refer to your eye as "phakic" only when your natural lens is still in place.

"Pseudophakic" refers to an eye where the crystalline lens has been replaced by a "pseudo" (artificial) lens, as is done during cataract surgery. (An "aphakic" eye would have no lens at all, either natural or artificial.) Therefore, the main difference between the Verisyse implantable contact lens and traditional IOLs is the fact that the Verisyse phakic lens works in conjunction with the eye's natural lens and a pseudophakic IOL replaces the eye's natural lens. Typically, pseudophakic IOLs are used to treat cataracts, although some now address presbyopia. The Verisyse contact lens was designed to treat high myopia (nearsightedness).

What Benefits Does The Verisyse Lens Offer?

The Verisyse Phakic IOL is proven in its ability to correct severe degrees of refractive errors. While a person with a high degree of myopia may not be a good LASIK candidate, the Verisyse lens implant is highly effective in correcting such nearsightedness, as long as it can be corrected with lenses (such as glasses) between -5 and -20 diopters. If you have nearsightedness in this range, the Verisyse lens implant may be an excellent way to improve your distance vision without the use of glasses or contact lenses. Benefits of the Verisyse implantable contact lenses also include a proven record of safety.

Verisyse Convenience

Perhaps, the most sought after benefit of the Verisyse lens is convenience. Previously hindered by glasses and contacts, Verisyse patients are able to enjoy many activities more thoroughly, especially water sports like swimming, snorkeling, and scuba diving.

With a reduced dependence on corrective eyewear, Verisyse patients also experience a freedom from the clutter of contact lens solutions and supplies and from having to keep track of their glasses. Unlike traditional contact lenses, Verisyse implantable lenses are protected from surface wear and tear, and from the dust that causes dryness in traditional contacts.

When Should I Plan My Eye Surgery?

Your vision should be stable for at least six months prior to surgery. Your ophthalmologist should verify that your nearsightedness has not changed more than 0.50 diopters in the past six months.

Can Both Eyes Be Implanted During The Same Procedure?

The Verisyse lens implant may be implanted in only one eye at a time. Your second eye may receive an implant after your Harvard Eye surgeon determines that your first eye has healed sufficiently. It is common to perform the second eye implant surgery within 3 months of the first eye. Your ophthalmologist will discuss this with you in detail.

What Results Should I Expect?

Almost immediately following your Verisyse treatment, you should experience clearer vision. The Verisyse phakic IOL has a proven track record for delivering convenience, safety, and amazing results. The clinical trial for the Verisyse phakic IOL noted that 92 percent of the Verisyse patients achieved 20/40 or better visual acuity without the use of corrective lenses. (20/40 is considered to be the standard vision necessary to obtain a driver’s license.) Additionally, after three years, 44 percent of the trial participants had 20/20 vision.

The following table shows the percentage of patients from the clinical trial who achieved vision of 20/20 or better, and 20/40 or better. Most patients were able to achieve vision of 20/40 or better.

~ Am I guaranteed freedom from glasses or contact lenses?

The Verisyse phakic IOL does not stop the natural aging process of the human lens, whereby we lose the ability to "accommodate" or see both near and far without glasses. This aging process, known as presbyopia causes everyone to need reading glasses at some point in their early to mid-40s. As the Verisyse procedure corrects distance vision only, patients over the age of 40 will still need reading glasses after lens implantation. In some cases, you may need reading glasses after surgery even if you did not need them before.

~ Are adjustments an option?

It is possible that a secondary procedure may be performed to fine tune your vision. During the clinical trial of this lens, the following secondary procedures were performed:

• Lens repositioning

• Secondary refractive procedures (LASIK, AK, LRI or PRK)

• Resuturing of the wound leak, aqueous release, or insertion of punctal plugs

~ Once the Verisyse lens is implanted, can it be removed or exchanged?

The Verisyse lens implant is intended to be a permanent procedure. However, unlike LASIK surgery, no laser is required for Verisyse eye surgery and the procedure can be reversed or improved by performing an additional surgery to remove or exchange the lens. While the Verisyse lens can be removed without an exchange, vision may not return to what it was prior to surgery. Also, as you age, you may need to update your prescription. However, as more information on implantable contact lens procedures is compiled, it appears that most prescriptions remain constant. This minimizes the need to exchange the original implantable contact lens with a Verisyse of a different strength.

~ Will I feel the Verisyse after the procedure?

No. Verisyse eye surgery is a relatively quick and pain-free outpatient surgical procedure. You should not be able to feel a properly implanted Verisyse. At Harvard Eye, our main focus is on your comfort and best possible visual results.

~ Will my Verisyse lenses be obvious to other people?

No. The Verisyse lens implant is tiny in size, completely colorless, and placed on top of the iris, just behind the cornea. In this location it is virtually invisible to others unless they are extremely close and actively looking for the lens. Even then, the lens is difficult to see.

~ Will the Verisyse correct my astigmatism?

It is important to understand that the Verisyse lens does not correct astigmatism, which can cause blurry vision. If you have moderate to high astigmatism, a second procedure, such as conventional or wavefront-guided Lasik, PRK, LASEK, or Epi-Lasik may be recommended for the correction of astigmatism. Patients with symptomatic levels of astigmatism may still need thin glasses after Verisyse lens implantation.

What Complications Are Associated With The Verisyse Phakic IOL?

It is normal that signs associated with minor inflammation may be noticed by your ophthalmologist following your surgery. These types of symptoms usually are present after surgery because they are part of the normal healing process. However, they will decrease as time goes on, with most being completely resolved by 6 months after your implant. If your results with the Verisyse lens implant are not satisfactory, there may be a need for an additional surgical procedure to adjust the lens, exchange the lens or remove the lens. In some cases, you may need reading glasses after implantation of the Verisyse lens implant even if you did not need them before.

Complications associated with the implantation procedure and/or the lens itself are rare. During the clinical trials for this product, the following types of events were reported:

• 1.36% of patients had their IOL exchanged (due to inadequate surgical fixation, the lens optic size was smaller than their pupil size, or a power calculation error).

• 1.51% of patients had their IOL removed (due to inflammatory response, patient anxiety, the lens optic was smaller than their pupil size, postoperative trauma, or surgical trauma).

• 0.60% of patients had to have their IOL reattached (due to inadequate surgical fixation or postoperative trauma).

• 0.45% of patients required repair of their retina.

• 0.15% of patients experienced surgical trauma, which required retinal repair.

The following table shows the outcomes for optical visual symptoms for the patients in the clinical trial. This table compares the patients' preoperative levels for glare, halos and starbursts with their postoperative levels. Most patients experienced no change in these symptoms.

Is The Verisyse Procedure Safe?

Yes. Although all surgical procedures carry some risk of complications, the Verisyse lens has a proven track record of safety. Because Verisyse lenses are removable and do not alter the cornea, the occurrence of severe adverse effects is minimal. In most instances, the percentages of complications that develop with the Verisyse were lower than the same complications of other IOLs. Lens implant surgery is one of the most successful and commonly performed surgeries in the US.

Verisyse at Harvard Eye Associates:

If you are considering this form of vision correction surgery, or if you have any questions, please call Harvard Eye Associates. Our friendly staff is available to review your prescription numbers with you and schedule a full evaluation with one of our doctors if it is indicated.

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