Laser eye surgery

What is it? / Market background / Benefits / Limitations, drawbacks and risks

LaserMyEye, Inc.

History / Position on laser eye surgery / Mission / Vision & objectives / Management, staff and funding

What is laser eye surgery?

Laser eye surgery, also called laser vision correction (abbreviated as LVC hereafter for convenience), refers to one of three categories of elective refractive surgeries, which alter the focus of light passing through the eye in such a way that dependence upon corrective lenses (glasses or contact lenses) is reduced.

In LVC, an excimer laser is used to change the shape of the surface tissue of the eye (the cornea). In short-sighted patients, this is achieved by flattening the centre of the cornea; in long-sighted patients, by steepening it; and in patients with astigmatism, by making it more symmetrical.

While the techniques and tools employed in specific procedures (LASIK, PRK et cetera) vary, the underlying concept is the same in all procedures: to expose the thick middle layer of the surface tissue of the eye (cornea) by moving or removing the outermost tissue and ablating (vaporizing) tissue in the middle layer.

PRK was the first laser vision correction procedure and has been available commercially for nearly fifteen years.

LASIK, which became available in the mid 1990s, quickly superseded PRK in popularity and prompted massive growth of the industry itself, becoming in fact the first refractive surgery to gain widespread market acceptance.

Other more recently developed procedures both done in relatively smaller numbers but gradually gaining in popuarity include LASEK and IntraLASIK, which are essentially variations on existing procedures.

The laser eye surgery marketplace

At the time of this writing (in 2004) pproximately six million LVC procedures have been performed to date in the United States alone. In 2003, approximately 2.8 million procedures were performed worldwide, including approximately 1.2 million in the United States and 750,000 in western Europe. The highest per-capita LVC penetration is in the United States and Spain.

Supply: There are estimated to be well over 4,000 laser centers worldwide. More than half of the 15,000 practicing ophthalmologists in the US have received some training for refractive surgery and about 25%, or 3,800, perform LVC procedures regularly. LVC is typically provided in three different settings: surgeon-owned practices, laser centers owned and operated by corporations, and laser centers in institutional settings (e.g. universities and hospitals). Procedures are offered at a wide range of prices, with the cheapest perhaps around $500 (or equivalent) per eye and the average perhaps between $1,500 to $2,000 (or equivalent) per eye.

Demand: While refractive eye procedures have been commonly available since the 1980’s with RK, the excimer laser first began to be employed for LVC with the PRK procedure in the late 1980s. But while it represented a major technological breakthrough, PRK signally failed to stimulate substantial interest from the public when it became available to the public in the early 1990’s. It was not till the entrance of LASIK in the mid to late 1990’s, with its famed “wow” factor and convenience for patients compared to both PRK and RK, that refractive eye surgery received the boost that it needed to go truly mainstream.

LASIK, in short, radically redefined the economics of the refractive surgery industry (RSI). It presented a product so much more attractive to consumers that its marketing potential was recognised and capitalised upon to cause an exponential increase in market response during the ensuing years. Like Southwest and JetBlue in the airline industry, each of whose entrances to the market stimulated considerable new demand for air travel, LASIK was a breakthrough product destined to open the floodgates of demand for refractive surgery. This remarkable success pre-dated even approval by the FDA of the use of an excimer laser for this purpose. By 1999 when the first excimer laser approval was granted for myopic LASIK, LASIK already accounted for nearly 70% of all refractive procedures performed in the USA – performed on an “off-label” basis with lasers approved for PRK. Today, the number of LASIK procedures formed as a percentage of all refractive procedures is approximately 90%.

The rapidity of LASIK’s market penetration caused a critical break-through in the industry: coaxing public perception of elective eye surgery past a longstanding psychological barrier about eye surgery and paving the way for a sustainable market.

The LVC market has not been problem free. The battle for market share amongst national and regional chains saturating the market (as well as ever more independent practices) had barely reached full swing when the economic slump put a damper on discretionary spending – leaving a small trail of corporate bankruptcies in its wake as well as discouraging lower volume surgeons from trying to participate. Nevertheless LVC has held its own and with the economic recovery seems poised for steady, if not dramatic, growth. While lens implant procedures such as phakic IOLs now present an alternative, particularly for individuals with high prescriptions, it is probable that they will not immediately grow past a niche market, though this is soon to be tested in the US market. Meanwhile, refinements and variations to LASIK and PRK, such as LASEK, IntraLASIK, and Wavefront-guided treatments increase the attractiveness of LVC to certain market segments.

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Benefits of laser eye surgery

LVC is intended to reduce dependence on glasses and contact lenses. In some patients, it can eliminate the need for corrective lenses altogether for a number of years and in others, for certain activities.

Reduced dependence on glasses presents significant quality of life benefits for many individuals. Longtime glasses wearers, particularly with moderate or higher prescriptions, take pleasure in improved peripheral vision. Increased pleasure from leisure activities such as water sports is frequently cited as a motivation for surgery. People engaging in certain occupations or activities may have safety concerns about wearing glasses. To some, dependence on glasses represents a professional limitation. And there are myriad smaller ways in which freedom from glasses can be felt to be an advantage or more convenient. Many people feel appreciate no longer having the sense of vulnerability one might feel about glasses if they have ever lost or broken a pair in an inconvenient time or place.

For some, the cosmetic benefits of not having always to wear glasses is a primary motivating factor. But LVC is not generally considered a cosmetic surgery and according to a survey by Market Scope fewer than 8% of patients cite cosmetic benefits as the primary reason for having LASIK.

Reduced dependence on contact lenses may be at least as compelling a reason to have LVC. Many long-term wearers of contact lenses become intolerant of lenses and can no longer wear them regularly or for as many hours of the day as they need. Some, particular patients with astigmatism, may struggle to get contact lenses that fit well and give them consistently good vision. Almost all contact lens wearers can appreciate the appeal of ridding themselves of the hassle factor involved in using contact lenses – even the highly popular daily or weekly disposable kind.

Whatever the motivation for surgery, it is clear that those who are most likely to experience the greatest benefits are (a) those who have thoroughly researched their subject in order to understand whether they have any increased risk factors for an outcome that falls short of the objective and (b) those who have realistic and clearly articulated expectations from LVC as well as a factual understanding of the limitations and (c) those who have selected the best treatment profile available for their specific needs.

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Limitations, drawbacks and risks of laser eye surgery

Limitations (examples)

Permanence: LVC does not guarantee against future changes in vision.

Presbyopia: After the age of 40, LVC frequently is not generally expected to provide both near and distance vision free from glasses, due to the onset of presybopia. This is something patients do not always understand, although the counseling process seems to be improving somewhat in this area. The exception to this is the “monovision” approach, where one eye is corrected for near vision and the other eye for distance vision, but it is thought that 20% or more patients cannot adapt to the vision imbalance, therefore it is necessary to test monovision tolerance with contact lenses prior to surgery.

Prescriptions: Hyperopia (long sight) has less predictable results than myopia (short sight). Additionally, although LASIK is offered for very high prescriptions of myopia, higher prescriptions both have less predictable results and also carry substantially increased risk of vision quality defects.

Drawbacks (examples)

A patient undergoing LVC cannot expect to have the same quality of vision after surgery as before. The fundamental goal of LVC has always been to provide is improvement to something called uncorrected visual acuity – in other words “how low can you go” on a high-contrast black-on-white eyechart. It is perfectly possible to achieve the target visual acuity (in most cases, 20/20 or 6/6) and yet suffer from vision quality defects, such as ghosting (faint secondary images), reduced contrast sensitivity (slight blurring of vision and difficulty seeing clearly in poor lighting), night vision disturbances (starbursting and haloes around light sources) and increased or more bothersome floaters, to name a few. Any of these potential changes to vision quality may range from quite minor inconveniences to altogether debilitating and, for example, a patient may have excellent daytime vision but be no longer able to drive at night.

In the case of LASIK, a potential drawback of surgery is the amount of tissue affected, typically one third or more of the total thickness of the cornea. In some patients, a single treatment will render the patient ineligible for further treatments (commonly called “enhancements”) due to the necessity of maintaining the structural integrity of the cornea.

Cutting and ablating corneal tissue can interfere with tear film production and quality in ways that are not well understood. As of recently, persistent long-term serious dry eye conditions are becoming more widely recognised as serious problems for some patients and have highlighted the necessity of careful screening for any predisposition to dry eye (of which contact lens intolerance may be a sign). Women are at higher risk than men.

Risks

For a detailed listing (not necessarily exhaustive, but as near as we can get it) of complications and adverse effects of LVC please see the Complications Map in the Patient FAQ section of the website.

Complications: There are complications which can occur during or after surgery. Intra-operative complications include various types of equipment malfunction (including the microkeratome – which is an automated blade used in LASIK – and the excimer laser, used in all LVC procedures) and surgical technique. Post-operative complications include various types of healing complications or progressive conditions arising from, for example, an inappropriate treatment.

Adverse effects: These include failure to achieve the target uncorrected (i.e. without glasses) visual acuity because of undercorrection, overcorrection, or regression; loss of “best-corrected” visual acuity, that is, a reduction in how well one can see even with glasses; and vision quality problems such as those alluded to above under Drawbacks. Also included are dry eye conditions. As also mentioned above under Drawbacks, tear film may be disrupted. Dry eye conditions range from minor inconveniences (for example, causing periodic lubrication with artificial tear products) to serious conditions which do not respond well to treatment and which may substantially limit lifestyle.

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The history of LaserMyEye

LaserMyEye was first established in 2003 by Rebecca Petris and Margaret Dolan, LASIK patients in the UK and Ireland who had experienced long-term problems from their surgeries. We wanted to improve the safety of LVC and the experience of patients unfortunate enough to experience complications.

We began by establishing LaserMyEye.org in April 2003, initially focusing on providing information, tips, guidance and support to patients with complications, adverse effects or poor outcomes. From there we expanded to the role of educating LVC candidates and working with eye doctors to improve care. Highlights include speaking engagements at ophthalmologic conferences in Europe and a successful campaign for a parliamentary review of safety standards in laser eye surgery in the United Kingdom.

In June 2004 we took the decision to incorporate as a nonprofit organisation in the USA in order to extend our reach and diversify funding sources. Today, LaserMyEye is involved in many initiatives aimed at improving safety and quality of care in laser vision correction.

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LaserMyEye's position on laser eye surgery

LaserMyEye accepts that the laser eye surgery concept of reduced dependence on corrective lenses is a compelling opportunity for a very large number of consumers.

We want to make it possible for those consumers to access it (where appropriate) safely and with a solid, factual understanding of its benefits, limitations, and risks.

We fear that the exceedingly rapid and mostly unrestricted commercialisation of laser eye surgery has given rise to, on the part of the industry, unacceptable medical and business practices, and on the part of consumers, inappropriate assumptions, all of which in turn are causing higher than acceptable incidence of complications, adverse effects and poor outcomes.

We desire to help consumers understand what laser eye surgery can and cannot do, generally, and what it can and cannot and may or may not do for them, personally.

We consider it a fundamental right of patients to have a fact-based understanding of the risks to which they might subject themselves by undergoing an elective surgery.

We aim to help laser eye surgeons surgeons and other professionals involved in the refractive surgery industry identify ways to provide higher quality services.

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LaserMyEye's mission

LaserMyEye, Inc. is a 501(c)(3) [application pending] charitable, educational and scientific organisation founded to enhance the safety and efficacy of laser eye surgery by educating consumers, fostering improved standards for patient care, and promoting the wellbeing of patients who experience poor outcomes.

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LaserMyEye's vision and objectives

Our vision for consumer education

Goal: Increase consumer awareness of the benefits, limitations, drawbacks and risks of laser eye surgery.

Objectives:

INFORMATION: Information readily available to all consumers should include detailed information about all known contraindications (absolute and relative) and risk factors; treatment options (procedures, equipment and techniques); outcome statistics (including refractive results, retreatment rates, complications rates and rates of common adverse effects such as night vision disturbance and dry eye); known risks; known limitations and drawbacks; and alternative treatments including non-surgical vision correction.

ADVERTISING STANDARDS: Consumer advertising of laser refractive surgery should comply with all applicable regulatory standards. In particular, such advertising should not cause or advance the formation of inappropriate expectations by consumers, and should include warning labels about the most frequent adverse effects of laser eye surgery, including dry eye and night vision disturbances. (An example of an applicable regulatory body in the United States is the Federal Trade Commission.)

Our vision for patient care

Goal: Elevate the standard of care to reduce the incidence of adverse effects and long-term complications of laser eye surgery.

Objectives:

INFORMED CONSENT: Informed consent should be a process which commences well in advance of surgery and of which a consent form is the confirmation. Patient-specific identifiable risk factors for increased permanent side effects (such as pre-existing dry eye and higher refractive error) should be explicitly incorporated in the consent process. No verbal statements should be made which trivialise in the patient's mind the frequency and life-impact of common permanent side effects. No part of informed consent, including signing the consent form, should occur after the administration of sedating medication.

PATIENT SELECTION: Patient selection (screening) should acccurately and consistently identify patients with conditions known to increase the risk of permanent side effects and complications, including but not limited to appropriate evaluation of dry eye syndrome and correct measurement of the dark-adapted pupil diameter.

OUTCOME DOCUMENTATION: Visual acuity is deficient as a sole measure of the success of laser refractive surgery. Post-operative evaluation should include performance of corneal topography not later than one month after surgery, low contrast visual acuity testing, testing of vision quality or function using validated surveys, and the Ocular Surface Disease Index questionnaire regarding dry eye.

Our vision for complications patients

Goal: Improve the availability and benefit of medical care and wellbeing resources for individuals who experience poor outcomes from laser eye surgery.

Objectives:

PHYSICIAN COMMITMENT TO PATIENT CARE: The fiduciary relationship between the physician and the patient with an unexpected result should include: (1) maintenance of adequate access to care (regular and emergency); (2) acknowledgement, documentation and investigation of patient complaints; (3) advice about treatment options, including referral to other physicians and outside consultants if indicated; and (4) compliance with statutory requirements for providing patients with written records upon request.

PATIENT SUPPORT SERVICES: An unexpected or poor surgical outcome can cause excessive emotional distress and permanent side effects and complications often have a substantial adverse impact on quality of life. Patients who experience poor outcomes should have available to them an orientation program, regional and/or online support groups, and assistance in accessing medical care including ophthalmologic, optometric and psychiatric.

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LaserMyEye's management, staff and funding

LaserMyEye is directed and run entirely by volunteers. Our Board of Directors, which consists of consumer/patients who have had laser eye surgery, provides direction and governance. Rebecca Petris is responsible for planning and operations. Certain vital adminstrative functions (such as accounting, legal advice and web programming) are performed by paid contractors.

We are funded by individual donations from the public.

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