Intraocular lens

An intraocular lens (IOL) is a lens implanted in the eye used to treat cataracts or myopia. The most common type of IOL for cataract treatment are known as pseudophakic IOLs which work by replacing the crystalline lens which has been clouded over by cataracts. The second type of IOL, more commonly known as a phakic intraocular lens (PIOL), is a lens which is placed over the existing natural lens used in refractive surgery to change the eye's optical power as a treatment for myopia or nearsightedness.^[1] IOLs usually consists of a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye.^[2] IOLs were traditionally made of an inflexible material (PMMA), although this has largely been superseded by the use of flexible materials. Most IOLs fitted today are fixed monofocal lenses matched to distance vision. However, other types are available, such as multifocal IOLs which provide the patient with multiple-focused vision at far and reading distance, and adaptive IOLs which provide the patient with limited visual accommodation.

Insertion of an intraocular lens for the treatment of cataracts is the most commonly performed eye surgical procedure.^{[citation needed]} The procedure can be done under local anesthesia with the patient awake throughout the operation. The use of a flexible IOL enables the lens to be rolled for insertion into the capsule through a very small incision, thus avoiding the need for stitches, and this procedure usually takes less than 30 minutes in the hands of an experienced ophthalmologist. The recovery period is about 2–3 weeks. After surgery, patients should avoid strenuous exercise or anything else that significantly increases blood pressure. They should also visit their ophthalmologists regularly for several months so as to monitor the implants.

IOL implantation carries several risks associated with eye surgeries, such as infection, loosening of the lens, lens rotation, inflammation and night time halos, but a systematic review of studies has determined that the procedure is safer than conventional laser eye treatment.^[3] Though IOLs enable many patients to have reduced dependence on glasses, most patients still rely on glasses for certain activities, such as reading.

History

First permanent insertion of intraocular lens 8 February 1950

Sir Harold Ridley was the first to successfully implant an intraocular lens on 29 November 1949, at St Thomas' Hospital at London. That first intraocular lens was manufactured by the Rayner company of Brighton, East Sussex, England from Perspex CQ Polymethylmethacrylate (PMMA) made by ICI (Imperial Chemical Industries). It is said the idea of implanting an intraocular lens came to him after an intern asked him why he was not replacing the lens he had removed during cataract surgery. The acrylic plastic material was chosen because Ridley noticed it was inert after seeing RAF (Royal Air Force) pilots of World War II with pieces of shattered canopies in their eyes (this acrylic resin is known by several trade names including Lucite and Plexiglas). The intraocular lens did not find widespread acceptance in cataract surgery until the 1970s, when further developments in lens design and surgical techniques had come about. By the 21st century, more than a million IOLs are implanted annually in the United States.

Materials used for intraocular lenses

Acrylic MICS-IOL in holder

Polymethylmethacrylate (PMMA) was the first material to be used successfully in intraocular lenses. British ophthalmologist Sir Harold Ridley observed that Royal Air Force pilots who sustained eye injuries during World War II involving PMMA windshield material did not show any rejection or foreign body reaction. Deducing that the transparent material was inert and useful for implantation in the eye, Ridley designed and implanted the first intraocular lens in a human eye.

Advances in technology have brought about the use of silicone and acrylic, both of which are soft foldable inert materials. This allows the lens to be folded and inserted into the eye through a smaller incision. Specifically, acrylic lenses are a better choice in people who have a history of uveitis, or are likely to have to undergo retinal surgery requiring vitrectomy with replacement by silicone oil, such as persons with proliferative diabetic retinopathy or who are at high risk of retinal detachment, such as persons with high myopia.

In the United States, a new category of intraocular lenses was opened with the approval by the Food and Drug Administration in 2003 of multifocal and accommodating lenses. These come at an additional cost to the recipient beyond what Medicare will pay and each has advantages and disadvantages.

New FDA-approved multifocal intraocular lens implants allow most post operative cataract patients the advantage of glass-free vision. These new multifocal lenses are not a covered expense under most insurance plans (In the United States, Medicare decided to stop covering them in May 2005) and can cost the patient upwards of $2800 per eye. Latest advances include IOLs with square-edge design, non-glare edge design and yellow dye added to the IOL.

The trademarked "Natural Yellow" material is available in three hydrophilic IOLs. Dr. Patrick H. Benz of Benz Research and Development created the first IOL material to incorporate the same UV-A blocking and violet light filtering chromophore that's present in the human crystalline lens. This breakthrough material provides the exact chromophore the human retina has already specified for light protection.

Multifocal IOLs – provide for simultaneous viewing of both distance vision and near vision. Some patients report glare and halos at night time with these lenses.

Accommodating IOLs – allow for both distance vision and midrange near vision. These IOLs are typically not as strong for closer vision as the multifocal IOLs.

To incorporate the strengths of each type of IOL, some eye surgeons recommend using a multifocal IOL in one eye to emphasize close reading vision and an accommodating IOL in the other eye for further midrange vision. This is called "mix and match." Distance vision is not compromised with this approach, while near vision is optimized.

Other IOLs include:

• Blue Light Filtering IOLs filter the UV and high-energy blue light present in natural and artificial light, both of which can cause vision problems^{[citation needed]}; however too much filtering of blue light can increase depression, especially in the winter months (SAD).
• Toric IOLs (1998) correct astigmatic vision.

Definition of phakic, aphakic, and pseudophakic IOLs

Slit lamp photo of Pseudophakia: Posterior chamber Intraocular lens – note that Posterior capsular opacification is visible few months after implantation of Intraocular lens in eye, as seen on retroillumination

• Phakia is the presence of the natural crystalline lenses
• Aphakia is the absence of the natural crystalline lens, either because the natural lens has become a cataract, blocking vision, or to correct refractive error.
• Pseudophakia is the substitution of the natural crystalline lens with an IOL, as is often done after cataract extraction of to correct refractive error.

The root of these words comes from the Greek word phakos 'lens'.^[4]

Intraocular lenses for correcting refractive errors

Intraocular lenses have been used since 1999 for correcting larger errors in myopic (near-sighted), hyperopic (far-sighted), and astigmatic eyes. This type of IOL is also called phakic intraocular lens (PIOL), and the crystalline lens is not removed.

More commonly, aphakic IOLs (that is, not PIOLs) are implanted via Clear Lens Extraction and Replacement (CLEAR) surgery. During CLEAR, the crystalline lens is extracted and an IOL replaces it in a process that is very similar to cataract surgery: both involve lens replacement, local anesthesia, both last approximately 30 minutes, and both require making a small incision in the eye for lens insertion. People recover from CLEAR surgery 1–7 days after the operation. During this time, they should avoid strenuous exercise or anything else that significantly raises blood pressure. They should also visit their ophthalmologists regularly for several months so as to monitor the IOL implants. CLEAR has a 90% success rate (risks include wound leakage, infection, inflammation, and astigmatism). CLEAR can only be performed on patients ages 40 and older. This is to ensure that eye growth, which disrupts IOL lenses, will not occur post-surgery.

Once implanted, IOL lenses have three major benefits. First, they are an alternative to LASIK, a form of eye surgery that does not work for people with serious vision problems. Effective IOL implants also entirely eliminate the need for glasses or contact lenses post-surgery for most patients.^{[citation needed]} The cataract will not return, as the lens has been removed. The disadvantage is that the eye's ability to change focus (accommodate) has generally been reduced or eliminated, depending on the kind of lens implanted.

Two types of PIOLs have been approved by FDA. The VisianICL (Visian Implantable Collamer Lens), (FDA approved in 2004), produced by Staar Surgical Company and Artisan Myopia lens (FDA approved in 2004), produced by Ophtec USA Inc. The VisianICL is made of collamer, a biocompatible material, and the Artisan is a plastic lens.

Some of the risks that FDA have been found so far during a three-year study of the Artisan are:

• a yearly loss of 1.8% of the endothelial cells,
• 0.6% risk of retinal detachment,
• 0.6% risk of cataract (other studies have shown a risk of 0.5 – 1.0%), and
• 0.4% risk of corneal swelling.

Other risks include:

• 0.03 – 0.05% eye infection risk, which in worst case can lead to blindness. This risk exists in all eye surgery procedures, and is not unique for IOLs.
• glaucoma,
• astigmatism,
• remaining near or far sightedness,
• rotation of the lens inside the eye within one or two days after surgery.

One of the causes of the risks above is that the lens can rotate inside the eye, if the PIOL is too short if the eye was incorrectly measured, or because the sulcus has a slightly oval shape (the height is slightly smaller than the width). Toric IOLs must be powered and aligned inside the eye on a meridian that corrects the patient's preexisting astigmatism. Again, these lenses can rotate inside the eye postoperatively, or be placed incorrectly by the operating surgeon. Either way, the patient's preexisting astigmatism may not be corrected completely or may even increase. When IOLs are implanted in the aphakic patient—either after clear lensectomy for the correction of refractive error or after cataract extraction to restore eyesight—astigmatism in these patients is mainly attributable to the cornea. The surgeon can ascertains the astigmatic, or steepest, meridian in a number of ways, including manifest refraction or corneal topography. Manifest refraction is the familiar test where the eye doctor rotates various lenses in front of the eye, asking the patient, "Which is better (or clearer), this one or this one?" Corneal topography is considered a more quantitative test, and for purposes of aligning a toric IOL, most surgeons use a measurement called simulated keratometry (SimK), which is calculated by the internal programming of the corneal topography machine, to determine the astigmatic meridian on the surface of the cornea. The astigmatic meridian can also be identified using corneal wavefront technology or paraxial curvature matching.

Determining the astigmatic meridian: SimK vs. refraction vs. wavefront vs. CorT

Recently, Alpins et al. described a vector analysis algorithm, which they call CorT, to quantify corneal topographic astigmatism. The authors compared CorT with manual keratometry, SimK, corneal wavefront, and paraxial curvature matching. CorT proved to be significantly more reliable (less variable with smaller standard deviation) than the other approaches. The magnitude of ocular residual astigmatism (ORA) using CorT was the least and its magnitude was closest to refractive cylinder than all other parameters examined.^[5]

The corneal topographic astigmatism (CorT) is closer in magnitude and orientation to the manifest refractive cylinder (R) than is simulated keratometry (Sim K), the latter of which has been the standard for 25 years.

CorT can provide a reliable meridian (and magnitude) for the alignment (and power) of a toric IOL. The current standard practice amounts to estimating the meridian from multiple differing inputs (e.g., SimK, manual keratometry, IOL master keratometry, and Lenstar), which often differ in the meridian identified as “steepest.” CorT provides the most reliable orientation of the steep meridian and the most effective magnitude of the corneal astigmatism.^[6]

The variability of SimK values has been a point of frustration in the field in regard to the alignment of toric IOLs. Alpins expects that CorT will replace the SimK value, which has been the standard measure since the inception of Placido ring topography technology.^[5][6][7][8] This is described in greater detail in the corneal topography section.

Types of PIOLs

As with IOLs inserted after cataract extraction, phakic IOLs (PIOLs) can be either spheric or toric. The difference is that they are placed in an eye that retains the natural human crystalline lens. As with aphakic eyes, toric PIOLs have to be aligned with the meridian of astigmatism; toric IOL misalignment or rotation can lead to residual or even greater astigmatism postoperatively.

Depending on their placement site in the eye, PIOLs can be divided into:^[4]

• Angle-supported PIOLs: those IOLs are placed in the anterior chamber. They are notorious for their negative impact on the corneal endothelial lining, which is vital for maintaining a healthy clear cornea.

• Iris-supported PIOLs: this type is gaining more and more popularity. The IOL is attached by claws to the mid peripheral iris by a technique called enclavation. It is believed to have a lesser effect on corneal endothelium.

• Sulcus-supported PIOLs: these IOLS are placed in the posterior chamber in front of the natural crystalline lens. They have special vaulting so as not to be in contact with the normal lens. The main complications with this type is their tendency to cause cataracts and/or pigment dispersion.

Accommodating IOLs

One of the major disadvantages of conventional IOLs is that they are primarily focused for distance vision. Though patients who undergo a standard IOL implantation no longer experience clouding from cataracts, they are unable to accommodate, or change focus from near to far, far to near, and to distances in between. Accommodating IOLs interact with ciliary muscles and zonules, using hinges at both ends to “latch on” and move forward and backward inside the eye using the same mechanism as normal accommodation. These IOLs have a 4.5-mm square-edged optic and a long hinged plate design with polyimide loops at the end of the haptics. The hinges are made of an advanced silicone called BioSil that was thoroughly tested to make sure it was capable of unlimited flexing in the eye.^[9] There are many advantages to accommodating IOLs. For instance, light comes from and is focused on a single focal point, reducing halos, glares, and other visual aberrations. Accommodating IOLs provide excellent vision at all distances (far, intermediate, and near), project no unwanted retinal images, and produce no loss of contrast sensitivity or central system adaptation. Accommodating IOLs have the potential to eliminate or reduce the dependence on glasses after cataract surgery. For some, accommodating IOLs may be a better alternative to refractive lens exchange (RLE) and monovision.^[10]

The FDA approved Eyeonics Inc.’s accommodating IOL, Crystalens AT-45, in November 2003. Bausch & Lomb acquired Crystalens in 2008 and introduced a newer model called Crystalens HD in 2008. Crystalens is the only FDA-approved accommodating IOL currently on the market^[11] and it is approved in the United States and Europe.

Studies and peer reviews

In a September 2004 FDA trial involving 325 patients:^[12]

• 100% could see at intermediate distances (24" to 30") without glasses; the distance for most of life's activities
• 98.4% could see well enough to read the newspaper and the phone book without glasses.
• Some patients did require glasses for some tasks after implantation of the crystalens
• Vision was restored to 20/40 or better in 88% of patients compared to 35.9% of patients who received normal IOLs.

• In 2006, a 12 month study by Cummings et al. investigated contrast sensitivity and near visual acuity in patients who had received a Crystalens AT-45 versus those who received a standard IOL. Effectiveness was measured in terms of near, intermediate, and distance visual acuities and safety was evaluated by assessing complications. The study concluded that contrast sensitivity was not reduced compared to those receiving standard IOLs and provided good visual acuity at all distances in pseudophakic patients. There were no adverse complications reported. However, this study lacked a long-term follow up.^[13]
• Pepose et al. (2007) tested the combination of a multifocal IOL in one eye and an accommodating IOL in the other eye. The group found that any combination of Crystalens in one or both eyes was better for intermediate vision. ReSTOR (multifocal IOL) is better for near vision. The Crystalens and ReSTOR combination had better mean intermediate and near vision overall.^[14]
• Macsai et al. (2006) conducted a multicenter, nationwide study evaluating the visual outcomes of 112 cataract patients implanted with Crystalens IOL (n=56) versus standard monofocal IOLs (n=56). The Crystalens group demonstrated significantly better visual acuity compared to the monofocal patient group, as well as better distance and near vision 6 months post-operation.^[15]
• In overall FDA clinical results on uncorrected binocular vision in 124 patients, 92 per cent had distance vision of 20/25 or better, 98 per cent had intermediate vision of 20/25 or better, and 73 per cent had near vision of 20/25 or better 11 to 15 months after surgery. In addition, 73.5 per cent either did not wear spectacles or wore them most none of the time.
• Sanders et al. (2007) published visual performance results after Tetraflex accommodative intraocular lens implantation. They found that 6 months post-operatively, all patients had at least 1 diopter of accommodative amplitude. At 6 months, 92.2 per cent of eyes had 20/40 or better uncorrected distance visual acuity (UCDVA) and 50.6 per cent of eyes achieved 20/20 or better UCDVA. At near, 48.1 per cent of eyes achieved 20/40 or better uncorrected near visual acuity.^[16]
• However, at this time, there no long-term, well-designed clinical trials to support the accommodating technology of the Crystalens IOL.

Criticisms

• The main concern with accommodating IOLs is that there are no long-term, large-scale studies involving its use in patients. Such clinical studies using objective measurement techniques must be done to fully support the claim that accommodating IOLs can restore accommodative vision to the presbyopic eye.^[17]

• Though it is rare, potential complications include capsular bag contraction and posterior capsule opacification.^[10]

• It is more difficult to implant an accommodating IOL (due to the attachment of hinges) and recovery time may be longer than with a standard IOL.

• Patients should expect that his or her accommodative abilities will not be restored to perfect or near perfect function. Though vision is significantly improved, the degree of improvement will not be the same for all and some will still need glasses after surgery.

• Accommodating IOLs are expensive. Insurance companies do not cover these technologically advanced IOLs because long-term efficacy is still being determined.

• Older patients may not have the muscle strength to fully accommodate with the IOL. The longer the patient has compensated for presbyopia with reading glasses, the weaker the muscles used in accommodation are likely to be. If the patient cannot fully accommodate, reading glasses will still be needed.

Candidates

Generally, patients over 50 with cataract problems and no serious eye diseases are good candidates for the procedure. The patient must have functional ciliary muscles or zonules for haptics positioning. In addition, the pupils must dilate adequately, as the IOL will induce glares in low-light environments if the pupils dilate too large. Accommodating IOLs are beneficial not only for patients with cataracts, but also those who wish to reduce their dependency on glasses and contacts due to myopia, hyperopia and presbyopia.

Post-operative care is similar to that of normal IOLs. However, patients must include ophthalmologic exercises such as puzzles and word games as a part of their daily regimen in order to tone up their ciliary muscles and attain the maximum benefit from the accommodating lenses.^[18] These exercises should be done consistently for 3–6 months and the patient's performance monitored by their eye care professional.

Other promising multifocal/accommodating IOLs currently in clinical trials include Accommodative 1CU (HumanOptics, Erlangen, Germany), Smartlens (Medennium, Irvine, CA), and dual optic accommodating lenses such as Sarfarazi (Bausch and Lomb, Rochester, NY) and Synchrony (Abbott Laboratories, Abbott Park, IL).

Synchrony IOL is anticipated to receive FDA approval in 2012.

See also

• Aphakia
• Capsulorhexis
• Contact lens
• Adjustable-focus eyeglasses
• Implantable Collamer Lens
• Inocular Lens

References

Suggested reading

• Shearing, S. "History of the PMMA Intraocular Lens". Ophthalmic Hyperguide. Vindico Medical Education and Allergan.  Note: requires login to reach article content – link not working 1 April 09

• Thompson K (inventor). "Near Vision Accommodating Intraocular Lens with Adjustable Power" (PDF). U.S. patent No. 5,607,472. Archived from the original on 2006-09-07. Retrieved 2007-02-04. 

External links

• "CIMA Technology" Inc. – Production of High-quality Intraocular Lens, made in USA.
• "Latan®" LTD – Production of Intraocular Lens, Russian Federation.
• "Reper" LTD – Production of High-quality Intraocular Lens (Russian Federation)
• "Aurolab" - Production of high quality, affordable Intraocular lenses in India & exported worldwide.