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October 2008

Research Addresses Patient Satisfaction, Safety of LASIK

David G. Hwang, M.D., F.A.C.S.
Ophthalmologist
Director of the UCSF Cornea and Refractive Surgery Service and UCSF Laser Vision Center
Medical Director of UCSF Ophthalmology

Richard L. Abbott, M.D.
Ophthalmologist
Thomas W. Boyden Health Sciences Clinical Professor at UCSF

With an estimated 16 million patients worldwide having undergone laser-assisted in situ keratomileusis (LASIK) and more than a decade of clinical study and technological innovation, LASIK is considered one of the most successful and safe elective procedures.Using the latest LASIK techniques and technology, ophthalmologists performing LASIK on patients with low-to-moderate degrees of nearsightedness can expect to achieve 20/40 vision more than 98 percent of the time, and uncorrected vision of 20/20 or 20/25 in more than 90 percent of cases.

The safety record is similarly excellent. Loss of best corrected vision to worse than 20/40 is rare after LASIK, occurring in about only 3 per 1,000 cases. Serious complications, such as infection or corneal damage, occur even more infrequently in fewer than 1 in 1,000 cases.

Despite these excellent results, about 5 percent of patients report some dissatisfaction with LASIK. Interestingly, this rate is significantly higher than the estimated 1 percent incidence of more serious post-LASIK side effects such as worse vision, painful dry eye, glare and inability to drive at night. It appears that the majority of dissatisfied patients may not suffer from serious side effects or complications, but that other factors may be at play.

Dissatisfaction After LASIK

The causes of dissatisfaction after LASIK vary, but an important cause may be a lack of realistic expectations or awareness about common symptoms that patients may temporarily experience during normal recovery.

Patients contemplating LASIK often expect that the procedure can and should achieve 20/20 or "better than 20/20" vision. Patient counseling can help them understand that while the probability of excellent visual outcomes is very high, a 20/20 or "perfect visual outcome" cannot be guaranteed.

Preoperative counseling also can help patients understand that most of the commonly reported side effects, such as dry eye, fluctuating vision and nighttime glare, are minor and temporary. If they occur, resolution typically occurs within a few months.

Careful patient selection and preoperative counseling play a critical role in minimizing dissatisfaction. Meticulous and detailed exams can help pinpoint potential problem areas that may reduce the probability of a good result or increase the likelihood of side effects or complications.

A careful history and exam can help rule out patients with systemic or ocular diseases that may be absolute or relative contraindications to LASIK, such as uncontrolled diabetes, severe autoimmune disease, severe dry eye, herpes infections of the eye, early cataracts or other ocular diseases. A detailed assessment of the physical and optical parameters of the patient's cornea can help determine cases in which the cornea is too thin or too distorted for LASIK. Finally, patients should be over the age of 21 with stable vision for at least two years prior to LASIK. Otherwise, the likelihood of a stable visual result after LASIK may be compromised.

A careful preoperative evaluation serves the purpose of counseling patients as to expected outcomes after LASIK and identifying occasional patients who may have unrealistic expectations even after appropriate counseling. Psychodynamic factors may affect patient satisfaction after LASIK. For example, patients who are depressed or who have an overly perfectionist personality may have unrealistic expectations or be unprepared for the recovery period.

Renewed Scrutiny by FDA

Despite an excellent efficacy and safety record confirmed by clinical studies, LASIK is undergoing renewed scrutiny with respect to patient satisfaction and clinical outcomes. Much of the impetus for this comes from an April 2008 Food and Drug Administration (FDA) hearing convened in response to complaints voiced by a small group of dissatisfied LASIK patients.

The FDA continues to view properly performed LASIK using one of the many FDA-approved laser systems as "safe and effective." Nonetheless, the FDA — in collaboration with the American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery and National Eye Institute — is planning to begin a study in 2009 on LASIK outcomes and the impact of LASIK on patient quality of life. Additional relevant information will be collected from a national network of 350 medical facilities across the United States.

The FDA Panel on Ophthalmic Devices also is reviewing recommendations to update LASIK device labeling and LASIK educational information for patients considering the procedure.

A recent UCSF study of LASIK malpractice suits and claims provides new information on practice patterns that correlate with patient dissatisfaction. Data from the Ophthalmic Mutual Insurance Company (OMIC) showed a threefold increase in LASIK malpractice claims and suits related to patient dissatisfaction between 1998 and 2001, a period that corresponds to the first few years after LASIK approval. Using data from OMIC, the study investigated LASIK and PRK surgeon predictors that correlated with a higher risk of a malpractice claim or suit related to patient dissatisfaction.

The study found that the most significant predictive factors for LASIK claims and suits were surgical volume and whether a surgeon had experienced a prior claim or suit. Centers that performed more LASIK procedures per doctor had a significantly higher rate of malpractice suits. Physicians without a claim or suit performed an average of 162 cases per year compared to 491 cases per year for those surgeons with a claim or suit.

Lower volume physicians experiencing fewer lawsuits may be explained in part by the fact that higher case volume correlates with increased exposure. However, this finding raises the possibility that in high-volume practices, the time spent per patient in the preoperative evaluation may tend to be compressed. The UCSF study found that spending more time with a patient prior to LASIK lowered the risk of incurring a claim or suit. Spending adequate time during the preoperative consultation helps develop a rapport with the patient, build appropriate expectations and ensure an accurate understanding of the procedure.

Latest LASIK Technology

Careful patient selection and counseling are key to achieving good patient outcomes and satisfaction after LASIK, but equally important is the use of the latest diagnostic and surgical technology and the exercise of meticulous and consistent surgical technique. New technical developments over recent years include wavefront-guided laser ablation, also known as custom LASIK, as well as "all-laser LASIK."

In custom LASIK, a detailed optical map of the cornea and other optical structures is obtained. From these data, a tailored treatment plan is designed with the aim of reducing optical aberrations that are naturally present to some degree in every person's eye. This may result in improved optical performance, which is particularly important when performing challenging visual tasks such as night driving and other visually demanding activities under low-light situations.

In "all-laser LASIK," a femtosecond laser (IntraLase ™) is used to precisely cut the corneal flap to prepare for sculpting the cornea. It is performed using another type of laser called the excimer laser. In contrast to flap creation using a mechanized surgical cutting instrument called the microkeratome, the femtosecond laser approach improves the reproducibility and precision of this key step.

The cost of acquiring and maintaining state-of-the-art laser systems is high and is a primary driver of the cost of LASIK that typically is not covered by health or vision insurance. Centers that offer the latest technology and a selection of different laser platforms are positioned to provide the best-available technology for any given clinical circumstance or situation.

Role of Primary Care Physicians

Patients seeking LASIK often ask their primary care physicians for their thoughts regarding the procedure and the names of trusted surgeons.

In addition to identifying trusted surgeons, primary care physicians can assist patients by helping them understand key factors governing success — aligning expectations, undergoing a detailed evaluation and thorough counseling by an experienced and well trained LASIK surgeon, and choosing a center that offers the latest technology and has an outstanding safety track record.

Although LASIK has an excellent patient satisfaction rate overall, attention to these factors can help minimize patient dissatisfaction and maximize successful outcomes.

UCSF Approach to LASIK

UCSF Medical Center — a top 10 hospital for ophthalmology care in the nation and one of the most experienced centers for specialized surgical eye care on the West Coast — applies a "best practices" approach, beginning with careful selection of surgeons and concluding with the final postoperative visit. To maximize outcomes and safety, an express emphasis is placed on quality rather than on high volume. For example, the pre-operative LASIK consultation at UCSF typically lasts two to 2.5 hours, significantly longer than the hour-long consultation considered normative in many other LASIK practices.

Experience counts, and each of the board-certified, fellowship-trained attending surgeons who performs LASIK at UCSF possesses more than 10 years of experience performing refractive surgery and has personally performed LASIK on well over 1,000 cases. More than 95 percent of patients undergoing LASIK at UCSF elect to have a UCSF attending surgeon perform the entire surgical procedure. In the remaining cases, in which patients elect to have LASIK performed by a fellow or resident to take advantage of reduced fees, there is close supervision by attending surgeons throughout the care, including the preoperative evaluations, surgery and postoperative care.

UCSF LASIK surgeons extend to their surgical practices techniques and standards that attempt to set a model. As a center with multiple laser platforms and the latest in LASIK technology, UCSF offers "best in breed" surgical equipment and the most up-to-date techniques, including custom LASIK and "all-laser" LASIK. Consequently, UCSF surgeons treat the widest possible range of refractive eye conditions with excellent results, including even extreme degrees of nearsightedness, farsightedness and astigmatism.

UCSF surgeons also are frequently called upon to consult in specialized or complex situations and to help manage patients who have experienced surgical complications after LASIK performed in other settings.

Another differentiating feature is that all surgical aftercare at UCSF is performed by the operating surgeon until the patient's postoperative recovery is complete. This differs from some centers in which some or all of the post-LASIK follow-up is delegated to the referring eye doctor. Often the referring provider is an eye care professional who does not perform LASIK and who may be less experienced with the prompt recognition and treatment of postoperative issues.

To date, not a single UCSF LASIK patient has experienced a postoperative infection or developed serious corneal damage requiring corneal transplantation or surgical repair.

For more information about LASIK at UCSF Medical Center, contact the Physician Referral Service at UCSF Medical Center:
Phone (888) 689-UCSF or (888) 689-8273
Email referral.center@ucsfmedctr.org

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