Phakic Lens Implants in NYC

Q: Who Is A Good Candidate For Verisyse™ Phakic Lens Implants?

Candidates for Verisyse™ phakic lens implants usually have severe vision problems and a prescription range between -5 to -22 diopters. Candidates for Visian ICL must be at least 21 years old with a prescription between -3.00 and 20.00 diopters.

Verisyse™ and Visian ICL Phakic Lens Implants

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

“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.”

Dr. Gregory Pamel has been interviewed on four news stations including ABC, Fox News, UPN, and New York 1 for his work with the 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.

In addition to the Verisyse™, Pamel Vision & Laser Group offers the Visian ICL (implantable collamer lens) by STAAR for patients who are not candidates for laser vision correction procedures like LASIK and PRK.

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 eye surgery is the primary procedure used in the United States to surgically correct refractive errors. 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 at least one of three 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 thickness of a potential candidate’s corneas 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.

Verisyse™ and Visian ICL

There are two FDA-approved phakic IOLs for treating nearsightedness.

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 channels WABC, NY 1, and WUPN to discuss the Verisyse™ phakic lens implant.

Visian ICL (implantable collamer lens) is made of a soft biocompatible collagen copolymer that cannot be seen or felt in the eye. It is placed behind the iris of the eye and in front of the eye’s natural lens. Unlike the Verisyse™ implant, which is rigid in form, the Visian ICL is flexible and can be folded during implantation. Because of this, a smaller surgical incision is needed during the Visian ICL procedure than the Verisyse™ procedure. The lens can correct nearsightedness in the range between -3.00 to -20.00 diopters.

A three-year follow-up to clinical research based on 189 patients with the Visian ICL found promising results. The follow-up found 99 percent patient satisfaction, and 98.3 percent of patients had uncorrected visual acuity of 20/40 or better. Additionally, once vision was corrected, the correction was stable and did not change over the follow-up period. The incidence of halos, glare, double vision and night vision problems remained virtually unchanged from before surgery.

Complications with Visian ICL are rare but include over- or under-correction, halos, night glare, infection and loss of visual acuity.

Who is a candidate for 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 to schedule a complimentary consultation for Verisyse™ phakic lens implant procedure. Contact our office today.

Frequently Asked Questions

What is a phakic lens implant?

A 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, 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 good candidate for Verisyse™ phakic lens implants?

Candidates for Verisyse™ phakic lens implants usually have severe vision problems and a prescription range between -5 to -22 diopters. Candidates for Visian ICL must be at least 21 years old with a prescription between -3.00 and 20.00 diopters.

What kinds of examinations are performed prior to phakic lens implantation?

Prior to the 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 their phakic lens implant procedure. Patients with soft lenses must switch to spectacles at least 72 hours prior to the operation. Not leaving contact lenses out long enough for the cornea to return to its natural shape can lead to poorer vision after phakic lens implantation.

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

Once the 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 their 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 the procedure, the patient will remain in the ambulatory area and be discharged shortly thereafter.

How is the phakic lens implant procedure performed?

The 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 phakic lens implant. The Verisyse™ implant is positioned in the anterior eye chamber behind the cornea and in front of the iris. The Visian ICL is placed in the posterior chamber of the eye behind the iris and pupil and in front of the natural lens. Once the phakic lens implant has been centered, the doctor fastens it in place and sutures the incision.

Can phakic lens implants be seen?

Neither the Verisyse™ nor Visian ICL phakic lens implants can be seen by others.

What type of anesthesia is used?

The doctor numbs the eyes and the area around them with a safe local anesthesia called a peribulbar block. The patient is still awake during the 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 the phakic lens implant operation take?

Performed at our office, the phakic lens implant operation takes approximately 20 minutes per procedure. The patient is usually back to work and using the eyes the next day. The phakic lenses are implanted 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 phakic lens implant reacts and evaluate how the patient likes the implant.

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

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

How does the 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 phakic lens implantation. Also, while the reshaping of the cornea during certain procedures is permanent, the phakic lens implant operation is reversible – them implant can be removed at any time.

Are there any studies that compare phakic lens implants 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.

How much do 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?

Patients should be at least 18 years of age to be considered for the Verisyse™ phakic lens implant. To qualify for the Visian ICL, patients should be at least 21 years of age.

Can the phakic lens implant procedure be performed on children?

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

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™ or Visian ICL 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 phakic lens implants?

Although infrequent, some 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. Swelling of the cornea and cataract formation are also potential complications. However, no patients developed swelling of the cornea and fewer than 1 percent developed cataracts in the 1,140 procedures performed during the clinical trials in the United States.

How long does 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.

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 extensive experience performing LASIK eye 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 clar vision at 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 replaces the eye’s natural crystalline lens, providing 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 IOL used in procedures that do not involve removal of the eye’s natural crystalline lens.

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.

Visian ICL

A phakic IOL that replaces the natural lens of the eye. The Visian ICL (implantable collamer lens) was approved by the FDA in 2005.

Please call our office at (212) 355-2215 to schedule a complimentary consultation for Verisyse™ phakic lens implant operation. Contact our office today.