Visian ICL and Verisyse-Artisan Lens Implants

The Visian Implantable Collamer Lens (ICL - it is not an implantable contact lens) and the Verisyse-Artisan are both phakic intraocular lenses (P-IOL). A P-IOL is a "helper" artificial lens implanted inside the eye to reduce refractive error. P-IOLs are an alternative to conventional or wavefront Lasik, All-Laser Lasik, PRK, LASEK, and Epi-Lasik for patients with very high myopic (nearsighted-shortsighted) vision.

P-IOLs are approved by the FDA to fully correct up to 15.00 diopters (D) of myopia. People with more than 15.00 D of myopia may use a P-IOL to reduce their refractive error, but will not achieve full correction.

P-IOLs can be used for lower amounts of myopia correction, but are commonly not as appropriate as other refractive surgery techniques. P-IOLs are not currently approved for hyperopic (farsighted - longsighted) correction and the nature of a P-IOL tends to make them less ideal for hyperopic correction.

P-IOLs approved in the United States do not directly correct astigmatism, however the process of surgery may reduce astigmatism. If the patient has 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.

Generally P-IOLs are most suited for individuals well under the age of 45 with very high refractive error, i.e.: over 10.00 D myopia and either no astigmatism or very little astigmatism. Exceptions to this general rule are common.

P-IOLs tend to be better for people with high myopia than Lasik and similar laser eye surgery because the laser assisted techniques require greater amounts of corneal tissue to be removed to correct high refractive error may make the cornea too thin and unstable. P-IOLs do not thin the cornea.

Younger Patients Are Generally Best

P-IOLs are generally not ideal for persons over age 45 or anyone who is presbyopic. Presbyopia is when the natural crystalline lens of the eye is no longer fully able to change focus from items distant to items near (accommodation). This is when reading glasses or bifocals become necessary. If the patient is young, not presbyopic, and has a high refractive error, then a major advantage of P-IOL lens-based refractive surgery is that the natural crystalline lens remains untouched. This means that the high myopia can be corrected without limiting the ability to accommodate.

When fully presbyopic, the natural lens is fixed in its shape and replacement of the natural lens with  an artificial lens (RLE) should be considered, however RLE has its own set of limitations and risks. Some intraocular lenses used for RLE have the ability to provide near and distance vision as well as the ability to correct refractive error. It may be possible to reduce or resolve both presbyopia and myopia/hyperopia. A person at or over age 45 should consider presbyopia surgery as an option.

Two Types

There are two primary types of P-IOLs. Both are placed behind the cornea and in front of the crystalline lens, but one type is placed in front of the iris and the other is placed behind the iris. The Verisyse-Artisan P-IOL is placed in front of the iris. The Visian ICL is placed behind the iris. Each have distinct advantages and disadvantages.

Temporary and Removable

At some point P-IOLs must be removed. As we mature, the natural lens of the eye becomes cloudy. This is called a cataract. The process of cataract correction requires the removal of any P-IOL. Everyone will eventually develop cataracts if they live long enough. This issue directly affects both types of P-IOLs.

The Verisyse-Artisan lens that is placed in front of the iris can and usually does disrupt the endothelial cells on the back of the cornea. This disruption should be regularly monitored to determine if or when the issue becomes critical. At that point the Verisyse-Artisan must be removed to ensure the health and integrity of the cornea. This condition does not affect the Visian ICL.

If for any reason the P-IOL becomes problematic or undesired, it can be surgically removed in a process essentially the reverse of implantation.

Short But Steep Surgeon Learning Curve

The implantation of P-IOLs is significantly different surgery than Lasik, All-Laser Lasik, PRK, LASEK, or Epi-Lasik. P-IOL implantation is much more like cataract surgery than laser assisted refractive surgery. For this reason a doctor who has greater practical knowledge with cataract surgery may be a better choice than a Lasik doctor. Ideally, the P-IOL doctor would be well versed in both cataract and laser eye surgery.

The learning curve for P-IOL surgery is relatively short, but very steep. Trauma induced cataracts and significant loss of the endothelial cells are two complications often related to inexperience. It would probably best to select a doctor who has implanted at least 25 P-IOLs of the type being considered, and more is always better. Extensive cataract surgery experience may make this restriction less important.

The Verisyse Procedure

Implanting the Verisyse Phakic IOL is an outpatient procedure that takes approximately 15 to 30 minutes. Usually, one eye is treated at a time.

Before surgery the doctor will create peripheral iridotomies. A laser makes one or two small holes through the iris. This is to allow fluid to flow freely between the front and back of the iris. The procedure takes about 5 minutes. The patient will have blurry vision for the first few hours.

Drops will be placed in your eyes in order to reduce the pupil size. For better access to your eye, your doctor will use an instrument to hold your eyelids open during the procedure. A local anesthetic is given to numb the eye, so the procedure is virtually painless. A small incision is made in the cornea for the Verisyse Phakic IOL to be placed in the space between the iris and the cornea. The Verisyse Phakic IOL is centered in front of the pupil, and is attached to the iris to hold the lens in place. The small incision is closed with stitches that dissolve over time. A temporary shield will be placed over your eye to protect it for a few days after surgery.

• Visit the FDA Verisyse-Artisan web page.
• Read USAEyes's testimony to the FDA ophthalmic devices panel regarding the
  Verisyse P-IOL.

The Visian ICL Procedure

The procedure involves placing the Visian Phakic IOL behind your cornea between your iris and the natural lens of your eye. Before surgery the doctor must measure the depth of the anterior chamber of the eye to verify that there is enough room to add the Vision. An estimated one-third of candidates are disqualified because the anterior chamber is too shallow.

Implanting the Visian Phakic IOL is an outpatient procedure that takes approximately 15 to 30 minutes. Usually, one eye is treated at a time.

Drops will be placed in your eyes in order to enlarge the pupil size. For better access to your eye, your doctor will use an instrument to hold your eyelids open during the procedure. A local anesthetic is given to numb the eye, so the procedure is virtually painless. A small incision is made in the cornea for the Visian ICL to be placed in the space between the iris and the natural crystalline lens. The Visian ICL is centered behind the pupil, and supported by the inside walls of the eye. The small incision is closed with stitches that dissolve over time. A temporary shield will be placed over your eye to protect it for a few days after surgery.

Outside the United States the Visian is called the "Implantable Contact Lens". The FDA rightfully determined this name to be misinformative of the true nature of the surgery involved to implant the Visian. A P-IOL is not, by any stretch of the imagination, a contact lens. For the US market, the manufacturer adopted the name "Implantable Collamer Lens" to reflect the material used to make the P-IOL. It is inappropriate to call the Visian ICL an implantable contact lens.

• Visit the FDA Visian ICL web page.

If you are ready to choose a doctor to be evaluated for P-IOLs, conventional or wavefront Lasik, All-Laser Lasik, PRK, LASEK, Epi-Lasik, NearVision CK, RLE, or any refractive surgery procedure, we highly recommend you consider a doctor who has been evaluated and certified by the USAEyes nonprofit organization. Locate a USAEyes Evaluated & Certified Eye Surgeon.

---

Current P-IOL Medical Journal News...

Long-term experience with mixing and matching refractive array and diffractive CeeOn multifocal intraocular lenses.

Related Articles

Long-term experience with mixing and matching refractive array and diffractive CeeOn multifocal intraocular lenses.

J Refract Surg. 2008 Mar;24(3):233-42

Authors: Gunenc U, Celik L

PURPOSE: To compare visual performance of the refractive Array SA40N and the diffractive CeeOn 811E multifocal intraocular lenses (IOLs) and to evaluate the potential benefits of combining both multifocal IOLs in the same patient. METHODS: Two groups of cataract patients were unilaterally implanted with either the CeeOn diffractive (n = 10) or the Array refractive multifocal IOL (n = 10). Another group was bilaterally implanted with one of each multifocal IOLs (mix & match group, n = 10). Visual acuity, spectacle independence, depth of focus, contrast sensitivity, presence of photic phenomena, and patient satisfaction were assessed postoperatively. RESULTS: All eyes achieved good distance visual acuity but better uncorrected near vision was achieved with the CeeOn diffractive design. Contrast sensitivity with either multifocal IOL was at the lower limit of the normal range but when multifocal IOLs were combined in the same patient, contrast sensitivity was not significantly different from phakic controls. Defocus curves revealed a superiority of CeeOn diffractive design for near and Array refractive design for intermediate but mix & match patients performed better overall than the other patients, particularly for intermediate distances, which was reflected by total independence from spectacles in 90% of patients compared to 60% in the other groups. Visual outcomes remained unchanged over time (1 month vs 6 month vs > 3 years). CONCLUSIONS: Bilateral implantation with a diffractive multifocal IOL in one eye and a refractive multifocal IOL in the fellow eye is safe and could provide patients with better intermediate vision, increased depth of focus and contrast sensitivity, and also less dependence on spectacles.

PMID: 18416257 [PubMed - in process]