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History

History

First permanent insertion of intraocular lens 8 February 1950

Sir Harold Ridley was the first to successfully implant an intraocular lens on November 29, 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. Plastic materials were used later, when Harold Ridley noticed that they were inert, after seeing RAF (Royal air Force) pilots of World War II with pieces of shattered canopies in their eyes. 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. Currently, more than a million IOLs are implanted annually in the United States.

Materials used for intraocular lenses

This section requires expansion with:

reorganization, clarifications, better differentiation between the practices of different countries, and specific differences between PMMA, sillicone, and silicone acrylate.

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. PMMA and acrylic lenses can also be used with small incisions and are a better choice in people who have a history of uveitis, have diabetic retinopathy requiring vitrectomy with replacement by silicone oil or are at high risk of retinal detachment. Acrylic is not always an ideal choice due to its added expense. 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.

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.

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, eye surgeons are increasing 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.

Toric IOLs (1998) correct astigmatic vision.

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 lens.

Aphakia is the absence of the natural crystalline lens, either from natural causes or because it has been removed.

Pseudophakia is the substitution of the natural crystalline lens with a synthetic lens. Pseudophakic IOLs are used in cataract surgery.

The root of these words comes from the Greek word phakos 'lens'.

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 PIOL (phakic intraocular lens), 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 17 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.[citation needed] 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.

Most PIOLs have not yet been approved by FDA, but many are under investigation, and some of the risks that FDA have been found so far during a three year study of the Artisan lens, produced by Ophtec USA Inc, 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, because the PIOL is too short, or because the sulcus has a slightly oval shape (the height is slightly smaller than the width).

Types of PIOLs

Phakic IOLS (PIOLs) can be either spheric or toriche latter is used for astigmatic eyes. The difference is that toric PIOLs have to be inserted in a specific angle, or the astigmatism will not be fully corrected, or it can even get worse.

According to placement site in the eyes phakic IOLs can be divided to:

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 dry 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 it is 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 in distances in between. Accommodating IOLs interact with ciliary muscles and zonules, using hinges at both ends to atch on and move forward and backward inside the eye using the same mechanism for 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. 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), projects no unwanted retinal images, and produces no loss of contrast sensitivity or central system adaptation. Accommodating IOLs have the potential to eliminate or reduce the dependence on glasses post-cataract surgery. For some, accommodating IOLs may be a better alternative to refractive lens exchange (RLE) and monovision.

The FDA approved Eyeonics Inc. 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 and it is approved in the United States and Europe.

Studies and Peer Reviews:

In a September 2004 FDA trial involving 325 patients :

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 concludedthat 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.

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.

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.

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.

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.

Though it is rare, potential complications include capsular bag contraction and posterior capsule opacification.

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.

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 . These exercises should be done consistently for 36 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 (Visiogen, Inc., Irvine, CA).

See also

Aphakia

Capsulorhexis

Contact lens

Laser Blended Vision

Notes

^ Slade, Stephen. ccommodating IOLs: Design, Technique, Results. Review of Ophthalmology. 2005. 20 Mar 2009.

^ rystalens Accommodating IOL. USA Eyes. 2008. Council of Refractive Surgery Quality Assurance. 20 March 2009. < http://www.usaeyes.org/lasik/faq/crystalens-2.htm>

^ Segre, Liz. ntraocular Lenses (IOLs): New Advances Including AcrySof ReStor, Tecnis, ReZoom, and Crystalens. All About Vision. 2009. Access Media Group LLC. 20 Mar 2009.

^ United States Food and Drug Administration. Center for Devices and Radiological Health (CDRH). Crystalens Model AT-45 Accommodating IOL P030002. New Device Approval. CDRH Consumer Information. Updated Jan 21 2004. http://web.archive.org/http://fda.gov/cdrh/mda/docs/p030002.html

^ Cummings et al. "Clinical evaluation of the Crystalens AT-45 accommodating interocular lens Results of the U.S. Food and Drug Administration clinical trial. J Cataract Refract Surg. 2006 May; 32(5): 812-25.

^ Pepose JS, Qazi MA, Davies J, Doane JF, Loden JC, Sivalingham V, Mahmoud AM. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthamol. 2007 Sep: 144 (3) 347-357.

^ Macsai et al. Visual outcomes after accommodating intraocular lens implantation. J Cataract Refract Surg. 2006 Apr; 32(4): 628-33

^ Sanders DR, Sanders ML. Visual performance results after Tetraflex accommodating intraocular lens implantation. Ophthalmology. 2007;114:1679-1684

^ Glasser, Adrian. estoration of accommodation. Current Opinion in Ophthalmology. 2006 Feb;17(1):12-8.

^ rystalens Accommodating IOL. USA Eyes. 2008. Council of Refractive Surgery Quality Assurance. 20 March 2009. < http://www.usaeyes.org/lasik/faq/crystalens-2.htm>

^ Koch, Paul. n Exercise Program for Crystalens Patients: How to use word search games to help crystalens patients. Ophthalmology Management. September 2005. http://www.ophmanagement.com/article.aspx?article=86430

References

Shearing, Steven, MD. "History of the PMMA Intraocular Lens". Ophthalmic Hyperguide. Vindico Medical Education and Allergan. http://www.ophthalmic.hyperguides.com/tutorials/cataract/history_PMMA/default.asp. Note: requires login to reach article content - link not working 1 April 9

Manufacturers of IOL

http://latan.info/en/ IOL Manufacturer in Russia

http://freedomophthalmic.com IOL Manufacturer in India

http://www.alcon.com/en/index.asp IOL Manufacturer in USA

External links

Keith P. Thompson (inventor). "Near Vision Accommodating Intraocular Lens with Adjustable Power" (PDF). U.S. patent No. 5,607,472. http://www.ott.emory.edu/share/technologies/descriptions/92008.pdf. Retrieved 2007-02-04.

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