The History and Controversial Future of Refractive Surgery
Michael J. Ward

For many, life is about finding the quickest and easiest way to do something. When someone has to get up and spend several minutes everyday fumbling with contact lenses the size of pennies or deal with repairing broken glass frames, one looks back upon the days of their youth when their vision was perfect, or at least close to it. In fact, many medical treatments that currently exist are geared towards "youthifying" individuals. Whether trying to regrow hair (Propecia), gain an erection (Viagra) or lose weight (Fen-Phen) people are incredibly willing to open their wallets and subject themselves to some questionable treatments in order to regain a part of their youth.

An ailment that plagues the many people is diminishing eyesight. For hundreds of years, glasses were a solution to this problem allowing near-blind people to see again. In the 1950’s, the advent of contact lenses allowed people to appear "normal" despite having impaired vision. But even the minor inconveniences of contact lenses such as putting them on and not being able to see without them have become too much to tolerate. So with the development of corrective surgery in the 1970’s, there is no wonder why people dove at the possibility of seeing without glasses or contacts. The convenience of such a procedure would allow people to shed their quarter-inch thick glasses, forget their daily supply of contacts and allow them to worry about more important things, such as how to regrow their hair. For others, glasses or contacts do not easily correct their visual problems and surgery does make more sense.

In order to understand refractive surgery and its current state, one must first understand how visual aids work and their impact on the visual system. Light rays hit the eye and converge upon the retina. At the retina, light signals are converted into electrical impulses that travel to the brain via the optic nerve. These electrical impulses are then processed by the brain telling the individual what they see. If the rays converge too quickly or too late, the brain perceives a blurry image. Myopia is when light rays converge before the retina. This is also known as "nearsightedness." When an individual has myopia, they can clearly see objects at a close distance but have difficulty seeing objects far away. On the other hand, hyperopia or "farsightedness" is when the light rays meet beyond the retina. In this case, images that are close are blurry whereas distant objects are perceived clearly. Another condition associated with refractive surgery is astigmatism. This occurs when there is an irregular shape of the clear coating surrounding the eye called the cornea, causing light rays to scatter blurring both near and distant vision.

The cornea is also extremely important in vision because it is responsible for seventy percent of the eye’s focusing power. Before surgeons altered the cornea, eye doctors prescribed lens in the form of glasses and contact lenses. Depending upon the impairment-whether the eye is too long, too short, irregularly shaped or whatever the case may be, lenses can accommodate these deficiencies. Provided the structures of the eye such as the retina, cornea and optic nerve are intact and the problem lies in the light rays landing properly, vision can be corrected.

The next frontier for ophthalmology was to physically manipulate the eye so that light rays could be appropriately directed to its target, the retina. The first evidence of this dates back almost two hundred years to the 19th century when physicians noted that while individuals with corneal injuries had decreased visual ability, their nearsightedness was greatly reduced. Unfortunately, little attention was paid to this finding. However, in the 1950’s a Japanese physician, Dr. Sato, performed incisions in thousands of myopic individuals. Because he cut too deep, no significant findings arose out of this exorbitant number of surgeries. Not until the 1970’s when a patient supposedly went to a Russian physician with glass in his cornea. This physician, Dr. Vyataslov Fyodorov, removed the glass and allowed the eye to heal. Unlike the patients of Dr. Sato, the glass did not cut too deeply into the cornea. When the patient’s eye healed, vision was dramatically increased. This inspired Dr. Fyodorov to make similar incisions in the corneas of patients careful not to cut too deep. With that, modern keratotomy, or "cornea cutting" was born.

Radial Karatotomy (RK) is the natural outgrowth of Dr. Fyodorov’s surgeries. Many U.S. surgeons went to Russia to learn this technique and returned to America to develop and refine it. RK involves using a diamond edged cutter to make shallow incisions into the cornea all around the eye. This procedure works by weakening the cornea causing it to flatten out. If performed correctly, the cornea flattens enough to project light rays onto the correct spot of the retina.

However, many problems are associated with RK. A group led by Emory University physician, George Waring III, conducted a study on RK entitled "Prospective Evaluation of Radial Keratotomy" or simply "PERK." PERK concluded that as a result of RK, healing is slow, unpredictable and indefinite. Another complication is that corneas could also rupture during blunt trauma (fight, airbag). A study on cadavers which are deceased humans, found that RK caused an eye to rupture significantly easier than other eyes which had different, more commonly used procedures such as LASIK and PRK also mentioned in this paper. This study also found that patients who had RK in the 1980’s had an increased need for cataract surgery and corneal transplants. Also, ten years post-surgery, patients still commonly experience visual aberrations such as halos and glare. Despite this, PERK surgeons, National Eye Institute, American Academy of Ophthalmology declared RK "reasonably safe and effective" So far, an estimated one and a half million people have had this procedure.

As technology developed and the understanding of lasers improved, the same effect of RK was accomplished with lasers. Instead of making incisions in the cornea, this new procedure entitled Photorefractive Keratectomy (PRK) removes corneal tissue to flatten it. PRK proved to be incredibly more reliable and predictable than its predecessor, RK and quickly replaced it. This finding is understandable considering RK is based upon the skill of a surgeon’s hand versus a machine, which can produce consistent results. Interestingly, RK is still widely practiced today. Because a knife is used in RK, the Federal Drug Administration (FDA) has no way of regulating this procedure. The FDA has no jurisdiction over any surgical procedure that uses a knife. Otherwise the FDA would have to rigorously evaluate every surgical procedure performed in this country-a task so daunting, no single organization has ever been created to do so. Also due to RK’s cheaper cost, many patients unknowingly choose an outdated procedure. PRK, on the other hand, is regulated by the FDA because of its use of a laser.

The laser is an excimer, which is a contraction of the two words "excited dimer." An excited dimer is when two molecules similar in composition are energized creating a powerful force called a laser. Such lasers are made up of argon and fluorine gases that generate ultraviolet light at a wavelength of 193 nanometers (nm), A laser of 193 nm is optimal for removing corneal tissue while leaving other tissue intact. This is important so that only corneal tissue is affected keeping the rest of the eye in its original shape and composition. Experiments with different lasers of varying wavelengths such as 248 and 351 nm proved not to be as effective because they are lower in energy. Also, the 193 nm laser produced consistent and reproducible results in laboratory animals making it a better tool for human use.

When the laser is fired directly upon the eye, cells that cover the eye are destroyed. These cells, called epithelial cells, coat the surface and may not grow back if destroyed. Although better than RK, full recovery can take up to one year. Regardless, the cornea is more stable following PRK as opposed to RK. But like RK, PRK is characterized by post-operative pain, a need for steroidal treatments to enhance recovery and visual aberrations such as glare and halos can occur. Halos are the rings around lights one often sees when they get a raindrop or other types of solutions in their eyes.

Other more typical complications resulting from PRK include over or undercorrection. If this occurs the patient can become myopic or hyperopic even if they were not prior to the operation. Additional surgeries can be performed but the chance for success decreases with every new procedure. Not to mention, exposing oneself to additional operations increases the chance of complications that surgery can cause. Another side effect of RK can be bacterial infection, which can lead to blindness in that eye. Another more common problem is a disturbance in night vision, which occurs in 45% of patients .

Other less successful procedures have been developed such as ALK (Automated Lamellar Keratomileusis) which uses a microkeratome to cut off the front flap of corneal tissue. Many problems were found with this procedure such as increased rates of infection, heightened post-operative pain and decreased vision. Surprisingly, this procedure is still performed today despite overwhelming evidence of its detriments. Again, the FDA cannot regulate this procedure except this time reasons different than those for RK are involved. In 1976, Congress expanded the FDA’s role to evaluate medical devices. Pre-existing devices were automatically accepted and classified based upon their risk to the patient’s health. The microkeratome existed before 1976 so the FDA immediately approved it. As a result, the regulation of microkeratome use is negligible if at all. Lasers currently used in refractive surgery , on the other hand, came into existence after 1976 subjecting them to FDA scrutiny. However, when the flap was not completely removed and then PRK was performed, the greatest rate of success occurred. This procedure called LASIK or Laser In-Situ Keratomileusis combines ALK and PRK and so far seems to be the easiest to recover from, most comfortable and most flexible for treating various degrees of myopia and other visual aberrations.

The recent acceptance of refractive surgery is incredibly affected by financial components. An article in Consumer Reports entitled "Surgery Instead of Glasses" (February 1994) suggested that a decrease in reimbursements for cataract surgery by Medicare and other managed care organizations prompted eye doctors to find other revenue generating procedures. Since such procedures are deemed by medical insurance companies to be "unnecessary," patients must pay the bill themselves. In fact, these patients are more motivated to pay for the surgery since it can dramatically enhance one’s life. Elective surgeries are commonplace because they reflect the patient’s choice. Elective surgeries such as breast augmentation, liposuction and other cosmetic surgeries are also fairly common because the patient must pay for the entire operation without insurance assistance. Such a procedure is the type of expenditure a patient would save up for. Interestingly, many cosmetic surgeries also attempt to return certain components of a patient’s life towards their youthful days; examples include facial looks, weight and in this case, eyesight.

The cost for PRK and LASIK are approximately $2,500 per eye. Again, this offers evidence as to why a cheaper, albeit more risky and unregulated procedure such as RK still exists. But PRK and LASIK are big business in the American corporate world. Lasers cost approximately $500,000 and run about $90,000 annually in maintenance costs. One company that produces such equipment called VISX has a market capitalization of $3.5 billion dollars. This means that all of VISX’s stock is worth this dollar amount. In fact, the recent run-up in VISX’s stock price over the past year combined with the lofty price-to-earnings ratio of 100 that it carries suggests that shareholders expect this company to earn a lot of money. For investors to pay such an expensive price for a stock it indicates that people expect VISX to continue to make as much money in the future as they recently have.

As corrective surgery maneuvers itself into everyday life, there are several issues that must still be considered despite its approval by multiple medical authorities. The first is that the stakes are high when patients gamble with their vision. An error could result in the loss or impairment of vision in an eye. Even though LASIK is considered the most reliable procedure, the success is greatly dependent upon the skill and experience of the surgeon. The less experienced the surgeon with the instrument that cuts the cornea called the microkeratome, the more likely the patient could experience complications. Although this evidence can be disputed by a study that looked at the rate of complications from both experience and inexperience microkeratome users and found an acceptably safe error rate of five percent. Regardless, a five percent error rate is still high and it is still greatly affected by experience.

Another issue is the outcome of the surgery in the future. The amount of data on this procedure is very limited because it is so new. Therefore, it is impossible to predict what the effect of aging will have on the future of an individual’s eyesight. For example, as an individual ages, their eye elongates. However, the LASIK or any other refractive surgery had already corrected for the change. In that case, two options are available. Either go back to wearing glasses and contacts again, albeit at a much weaker prescription, or have the surgery done again. Retreatment with LASIK surgery is less effective because the epithelial cells that cover the eye are able to grow inside the eye now that the flap of tissue is cut away. Another problem is that the flap of tissue made into a hinge can die and become a source for infection. These two complications occur in 40% of patients one year post-surgery. However, visual acuity and astigmatism were not affected in these patients. This same study also found that 100% of patients were satisfied following both the initial treatment and the retreatment.

The necessity of such a surgery is seriously in question. Any surgery is destructive and risks the chance of major complications. In this case, loss of vision and death are entirely possible. This procedure is solely a matter of convenience for people who no longer wish to deal with glasses or contact lenses. There are nonsurgical possibilities such as visual training, which can improve vision through exercises that concentrate on shifting focus. The problem with these exercises is that they are time consuming and require a lot of effort. In today’s fast paced society, few people want to spend two to three hours per week for several months exercising their eyes when they can fall asleep and have the same result in a single day. However, additional benefits such as improved reading comprehension, reading speed and the fact that the structure of the eye remains intact are additional benefits that must be seriously considered that cannot be offered by a surgical procedure.

Many people are convinced by the preliminary findings that these surgeries are safe and beneficial to those suffering from common visual abnormalities. While the results do appear very positive, caution must be taken. There is no long-term data because of the recent developments of certain popularized procedures. In fact, there are no comparable studies that would allow physicians to accurately predict what sort of effect these refractive surgeries can have on a patient’s eyes forty years from now. An interview with Wally Joyner, a professional baseball player with the San Diego Padres, indicated a typical lack of regard for the future many have, "I love it, I no longer have to hold the clock up to my face to figure out what time it is. What possible problems could I have in the future?" Joyner had 20/3000 vision which means that what he sees from 20 feet, other individuals can see from 3000 feet. In other words, his vision was extremely bad. Following the procedure, Joyner’s vision dramatically improved to 20/20, considered "normal" for visual acuity.

Especially recently, the United States has a tendency to immerse itself in medicine that enhances life. Ironically, without proper testing and enough data, such "life-enhancers" can prove to be detrimental. Before anyone undertakes such a procedure whether it is for their eyes, their weight or their hair, they must realistically understand the implications of their undertaking. This involves doing a lot of reading about the topic, interviewing patients who have already had the procedure and talking to a multitude of physicians. Again, laziness typically sets in and the patient does not want to do the necessary homework. As a result, the tendency is to trust the first physician a patient encounters. Objectivity is removed and the patient subjects him/herself to a limited perspective. An example is that of a physician who only performs RK surgery and may not tell her/him that PRK or LASIK have been found to be more comfortable and more predictable because their is a financial interest. Regardless, patients must exercise caution and objectivity when deciding upon any procedure, particularly when it comes to these new refractive surgeries.

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