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Verisyse Lens Implant

Verisyse™ Phakic Lens Implant

Featured story on New York 1 about Verisyse™ Phakic Lens Implant Operations

Former NBA star with the world champions San Antonio Spurs and current Director of Basketball Operations for the NBA, Brandon Williams underwent lens implant surgery to treat his extreme nearsightedness.

“I had been extremely nearsighted with my prescription in the -12 to -13 range for all of my adult life. Contact lenses were becoming intolerable and I knew lasik was not an option. The Verisyse lens implant Dr. Pamel placed in my eyes restored my vision as if I had perfect contact lenses on all of the time. I wish I had undergone the procedure while I was still playing professional ball, it would have transformed my career. The procedure was painless and the results were amazing even the next day. Dr. Pamel and his staff did an outstanding job from start to finish.”

– Brandon Williams

Dr. Gregory Pamel has been interviewed on four news stations including ABC, Fox News, UPN, and New York 1 for his work with the new Verisyse™ phakic lens implant, a treatment option for extreme eyesight problems.

At a meeting, Dr. Pamel trained other physicians around the country to implant the new Verisyse™ phakic lens implant.

The doctor also published a chapter in the first book on the Verisyse™ phakic lens implant.

What is a phakic intraocular lens implant (IOL)?

A phakic intraocular lens implant (or phakic IOL) derives its name from the Greek word for lens – “phakos.” A phakic lens implant is a lens implant that is placed within the eyeball solely for the purpose of correcting different types of vision problems. It is referred to as a “phakic” implant because the natural crystalline lens of the eye remains in place. In contrast, a “pseudophakic” implant is placed at the time of the cataract operation, during which the natural crystalline lens is removed. In fact, it replaces the natural lens. Research and development of phakic lens implants for ocular correction have been ongoing for more than 15 years.

LASIK is the principal procedure in the United States for surgically correcting refractive errors of a majority of the population. It involves reshaping the cornea using an excimer laser. Over the last five years, doctors have learned that this procedure has its limitations and is not the procedure of choice for every patient who has visual impairments. Approximately 20 to 25 percent of patients who are interested in this procedure are not candidates for several reasons: 1) their cornea is too thin to undergo the operation; 2) the eyeglass or contact lens prescription is too high; or 3) their corneal shape is too irregular for LASIK.

Patients with high levels of myopia (nearsightedness) may be better candidates for the phakic lens implant procedure than other vision correction procedures. Typically this would include patients who are above –8 diopters. At these levels, instability of the cornea can develop because the LASIK procedure requires removal of significant amounts of corneal tissue to achieve the desired effect.

The corneal thickness of a potential candidate helps determine whether the procedure can be performed on that person. Those patients whose corneas are too thin to undergo the appropriate amount of refractive correction should not undergo certain operations, but may consider undergoing the phakic lens implant operation. The main attraction of this procedure is that it is potentially reversible – the implant can always be removed or exchanged. No tissue is removed. The results of the phakic lens implant procedure indicate that for higher levels of refractive conditions, the quality of vision for patients is better than that seen with other treatments.

The Verisyse™ phakic lens implant, available at our office, is designed for patients with vision problems between –5 diopters and –22 diopters. It was originally developed in the Netherlands by the company Ophtec and is called the Artisan lens in Europe. This phakic lens implant has an 18-year track record with over 100,000 patients receiving the implants worldwide.

At Manhattan Eye, Ear and Throat Hospital, Dr. Gregory Pamel has been the principal investigator for the phase III FDA trial for the treatment of high myopia (nearsightedness). He traveled to the Netherlands to study the technique with the developer Jan Worst, M.D., more than 10 years ago and has had the longest experience of any doctor with the Verisyse™ phakic lens implant.

The FDA results have been outstanding, with 100 percent of the patients achieving 20/40 or better vision after the Verisyse™ phakic lens implant procedure. In addition, more than 50 percent of patients gained one or more lines of vision, meaning that patients saw better after the operation without spectacles than they did before the operation with spectacles.

Complications and side effects reported were minimal. A small percentage of patients reported glare at nighttime. Less than 1 percent of patients developed cataracts and even fewer patients than that had the Verisyse™ phakic lens implant removed. But the advantage of this procedure is that it is reversible, if necessary.

For those patients whose myopia (nearsightedness) worsens after receiving the Verisyse™ phakic lens implant, oftentimes they can undergo LASIK to treat the residual refractive error.

Recently, Dr. Pamel and his patients were featured on major news programs WABC, NY 1, and WUPN to discuss the Verisyse™ phakic lens implant.

Who is a candidate for Verisyse™ phakic lens implant?

  • Patients between 21 and 60 years old
  • Suffer from sight loss from -5 to -22 diopters
  • Suffer from sight loss from +3 to +12 diopters
  • No significant systemic disease
  • No additional ocular pathology

Please call our office at (212) 355-2215, or toll free at (888) 657-2010, to schedule a complimentary consultation for Verisyse™ phakic lens implant procedure. Contact our office today.

More information on ophthalmic products are available on Ophtec, Inc.

Verisyse™ Phakic Lens Implant Frequently Asked Questions

What is a Verisyse™ phakic lens implant?

The Verisyse™ phakic lens implant is a tiny (approximately 5 mm) plastic lens that is implanted in a patient’s eyeball. It is placed between the cornea and the lens. While other kinds of intraocular lens implants (monofocal IOL and multifocal IOL) are routinely used to replace the lens in a cataract operation , Verisyse™ phakic lens implants are now being studied to correct severe cases of ocular problems while the natural crystalline lens of the eyes remain in place.

Who is a candidate for Verisyse™ phakic lens implants?

Candidates for Verisyse™ phakic lens implants usually have severe vision problems. The FDA has approved the myopic (nearsighted) Verisyse™ phakic lens implant for patients more than 21 years old whose prescriptions range between -5 to -22 diopters. Currently undergoing FDA phase III testing is the hyperopic (farsighted) Verisyse™ phakic lens implants, for patients whose prescriptions are between +3 to +12 diopters. As several other factors need to be considered to determine eligibility for the clinical study, patients can receive a complimentary evaluation by our doctor at the Pamel Vision and Laser Group and principal investigator for the phase III FDA clinical trial.

What kinds of examinations are performed prior to Verisyse™ phakic lens implants?

Prior to Verisyse™ phakic lens implant procedure, the patient will undergo extensive testing to determine if he/she is eligible for the operation. This will include measurement of the prescription of the eyes, measurement of the pupil size, evaluation of the insertion of the iris, measurement of the cells on the back surface of the cornea (endothelial cell count), measurement of the intraocular pressure, and measurement of the depth of the space between the cornea and iris (the anterior chamber). Also the general health of the eyes will be evaluated and a retinal examination performed.

What happens in the days leading up to Verisyse™ phakic lens implant procedure?

Because contact lenses can change the shape of the cornea, patients are required to stop wearing their hard lenses and switch to spectacles at least two weeks prior to Verisyse™ phakic lens implant procedure. Patients with soft lenses must switch to spectacles at least 72 hours prior to Verisyse™ phakic lens implant operation. Not leaving contact lenses out long enough for the cornea to return to its natural shape can lead to poorer vision after Verisyse™ phakic lens implant operation.

What happens on the day of the Verisyse™ phakic lens implant operation?

Once the Verisyse™ phakic lens implant patient arrives at the Manhattan Eye, Ear and Throat Hospital, the nurse will administer a series of drops, check vital signs, and review medical history. Following the initial screening, the anesthesiologist will meet with the patient to review his/her medical history. A mild sedative will be administered intravenously, however, the patient will remain awake during Verisyse™ phakic lens implant operation. The doctor will then administer a local anesthetic to the eyes and then drape and prepare the eyes for the procedure. Following Verisyse™ phakic lens implant operation, the patient will remain in the ambulatory area and be discharged shortly thereafter.

How is the Verisyse™ phakic lens implant procedure performed?

The Verisyse™ phakic lens implant is smaller than a contact lens, but with two fastener extensions on either side. While the patient is under local anesthesia, the physician makes a small incision at the top of the cornea and slips in the Verisyse™ phakic lens implant between the cornea and iris. After the Verisyse™ phakic lens implant has been centered over the pupil, the doctor fastens it in place and sutures the incision.

If the Verisyse™ phakic lens implant is in front of the iris, can other people see it?

The Verisyse™ phakic lens implant cannot be seen by others.

What type of anesthesia is used?

The doctor numbs the eyes and the area around it with a safe local anesthesia called a peribulbar block. The patient is still awake during Verisyse™ phakic lens implant operation, but cannot see or feel anything. Alternatively, the physician may elect to perform the procedure under topical anesthesia alone.

How long does Verisyse™ phakic lens implant operation take?

Performed at our office, Verisyse™ phakic lens implant operation takes approximately 20 minutes per procedure. The patient is usually back to work and using the eyes the next day. Verisyse™ phakic lens implant is performed one at a time according to the FDA protocol, which requires a one to two week waiting period between procedures. This allows the ophthalmologist to see how the Verisyse™ phakic lens implant reacts and evaluate how the patient likes the implant.

What if a patient’s eyesight gets worse after the Verisyse™ phakic lens implant?

Candidates for this procedure should have a stable prescription, which is common for most people over the age of 25. If a Verisyse™ phakic lens implant patient’s prescription changes over time, he/she can still receive the procedure as it will not interfere with the Verisyse™ phakic lens implant implant.

How does the Verisyse™ phakic lens implant differ from LASIK?

LASIK uses energy to reshape the cornea to improve vision. While it has been very successful in patients with low to moderate ocular complications, it is not recommended for patients who have severe vision impairments. These patients are potential candidates for Verisyse™ phakic lens implantment. Also, the reshaping of the cornea during certain procedure are permanent, the Verisyse™ phakic lens implant operation is reversible – it can be removed at any time.

Are there any studies that compare the Verisyse phakic lens implant to LASIK?

Two separate studies were published in 2002 by the American Academy of Ophthalmology comparing the Verisyse™ phakic lens implant to LASIK. One study from Europe focused on patients with diopters ranging from -8 diopters to -12 diopters, and another study from Asia focused on correcting problems between -9 and -19.5 diopters. In each study, a group of patients received LASIK in one eye and the Verisyse™ phakic lens implant in the other. Both studies found that the majority of patients had better corrected visual acuity in the Verisyse™ phakic lens implant, and that patients felt their quality of vision was better with the Verisyse™ phakic lens implant. Both studies also found each method to be equally safe.

Where does the Verisyse™ phakic lens implant stand with the FDA?

Phase III clinical trials for the Verisyse™ phakic lens implant were completed and FDA-approved in September 2004. The Verisyse™ phakic lens implant has received approvable votes by the FDA’s Ophthalmic Devices Panel of the Center for Devices and Radiological Health (CDRH) and received final agency approval for treatment of vision impairmentof -5 diopters to -20 diopters. Data for the phase III study is still being collected.

How much does Verisyse™ phakic lens implants cost?

The cost for the Verisyse™ phakic lens implant procedure is $4,500 for each operation, including the cost of the implant, all pre- and post-operative doctor visits, the hospital fee, and anesthesia.

What is the age criteria for Verisyse™ phakic lens implants?

Under current FDA protocols, patients should be between the ages of 21 and 55 to be considered for the Verisyse™ phakic lens implant study. The minimum age requirement may eventually be lowered to age 18, providing the patient’s visual impairment are stable for at least one year prior to Verisyse™ phakic lens implant procedure. The youngest age at which other procedures can be performed is 19, according to FDA guidelines. In addition, certain patients over the age of 55 may qualify for a sub-study protocol and may be able to undergo Verisyse™ phakic lens implant procedure.

Can the Verisyse™ phakic lens implant procedure be performed on children?

There are certain instances in which the Verisyse™ phakic lens implant procedure may be appropriate for children, and studies are currently being performed under a “compassionate use” FDA protocol.

What happens if the patient gets Cataracts?

Cataract procedures are the most commonly performed ocular operations in the United States, with between 1 and 2 million procedures performed each year. Cataracts occur when the natural crystalline lens, which is one of two lenses the eyes use for focusing, becomes cloudy. If someone with a Verisyse™ phakic lens implant later requires cataract operations, both the phakic lens implant and the crystalline lens are removed at the time of the operation. A “pseudophakic” implant is then inserted, which takes the place of the cloudy crystalline lens, correcting the cataract as well as the visual impairment. Dr. Pamel is a premier NYC / Astoria / Queens cataracts surgeon.

What are the risks associated with Verisyse™ phakic lens implants?

Although infrequent, some Verisyse™ phakic lens implant patients have reported halos or a slight glare in their vision at night. As with all surgeries, there is also the remote possibility that patients will experience infection, although no infections were reported during the phase III clinical trial. Swelling of the cornea and cataract formation are also potential complications, however in more than 1,140 proceduress performed during the clinical trials in the United States, no patients developed swelling of the cornea and less than 1 percent developed cataracts.

How long does Verisyse™ phakic lens implant treatment last?

The Verisyse™ phakic lens implant should potentially last a lifetime. Even if a patient’s visual impairments becomes worse over time, he/she may still be a candidate for other procedures after the Verisyse™ phakic lens implant has been implanted to treat any residual prescription.

Please call our office at (212) 355-2215, or toll free at (888) 657-2010, to schedule a complimentary consultation for Verisyse™ phakic lens implant operation. Contact our office today.

Glossary of Terms

Artisan

The brand name of the IOL lens currently in Phase III clinical studies at Pamel Vision and Laser Group.

Cataract

A condition in which the eye’s natural lens becomes cloudy.

FDA

The abbreviation for the Food and Drug Administration. It is the United States governmental agency responsible for the evaluation and approval of medical devices and pharmaceuticals.

Hyperopia

The inability to see near objects as clearly as distant objects, and the need for accommodation to see distant objects clearly. This condition occurs when the eyeball is too short, and/or the cornea is flatter than normal.

IOL

The acronym for intraocular lens.

LASIK

The acronym for laser assisted-in situ keratomileusis, which refers to creating a flap in the cornea with a microkeratome and using an instrument to reshape the underlying cornea. Dr. Pamel is a board certified ophthalmologist with a great deal of experience performing laser vision correction surgery in New York.

Lens

A part of the eye that provides some focusing power. The lens is able to change shape, allowing the eye to focus at different distances.

Monofocal IOL

An intraocular lens that replaces the eye’s natural crystalline lens; it can provide vision in just one particular range of distances, either near or distance vision. Spectacles will often provide clear vision in the other range.

Multifocal IOL

An intraocular lens, replacing the eye’s natural crystalline lens, that can provide correction of both near and distance vision.

Myopia

The inability to see distant objects as clearly as near objects.This occurs when the cornea is too steep and/or the eyeball is too long, causing light rays to focus in front of the retina.

Ophthalmologist

A medical doctor specializing in the diagnosis and medical or surgical treatment of visual disorders and eye disease.

Phakic IOL

Taken from “phakos,” the Greek word for “lens” – describes the type of an IOL in which the eye’s natural crystalline lens is not removed.

Verisyse™

The brand name that replaced “Artisan” (the name used to market the lens in Europe) after the phakic IOL was approved by the FDA in 2004.

Please call our office at (212) 355-2215, or toll free at (888) 657-2010, to schedule a complimentary consultation for Verisyse™ phakic lens implant operation. Contact our office today.