Risk Management Issues in Radial Keratotomy Surgery

By C. Gregory Tiemeier, Esq., Richard L. Abbott, MD, and Jean Hausheer Ellis, MD, FACS

Digest, Summer, 1993

The elective nature and high patient expectations of radial keratotomy (RK) surgery present distinctive risk management challenges to ophthalmologists who perform this procedure. With this in mind, OMIC has developed strong underwriting guidelines for keratorefractive procedures. To date, there have been few RK-related claims against OMIC insureds, partly because only 15% of policyholders currently perform RK surgery. As more insured ophthalmologists incorporate the procedure into their practice, the potential for claims increases.

By adhering to the risk management guidelines set forth in this article, an ophthalmologist will be in a better position to successfully defend the care provided to an RK patient if a malpractice claim is made. The examples cited are from non-OMIC cases.

Informed Consent

Most patients elect RK to achieve less dependence on corrective eye-wear and contact lenses. Some patients, such as those in law enforcement or fire fighting, may choose RK so they can feel more secure and visually safe in their occupation. Because RK is generally an elective procedure, one of the greatest potential risk management challenges is the informed consent process.

With elective procedures like RK, it is important that the education surrounding the procedure begin with the patient’s first visit. Educational videotapes sometimes are used to give patients a general overview of the procedure. Some ophthalmologists follow up with a written test to determine if the patient truly understood the information imparted on the video. This can be an effective way to measure a patient’s understanding of the procedure, but it is not a substitute for a personal dialogue between the surgeon and patient. As with all surgical procedures, the operating ophthalmologist must personally conduct an informed consent discussion with the RK patient. Other health care professionals may be involved in the informed consent process, but this duty may not be delegated exclusively to non-ophthalmologists.

Timing of the ophthalmologist’s discussion with the patient is critical. If a videotape is shown, the informed consent discussion will be more meaningful if it follows the video since presumably the patient will know more about RK. When using the consent forms and written tests that accompany some videotapes, the patient should not sign the form until after talking with the ophthalmologist.

One patient successfully sued her ophthalmologist for lack of informed consent, based among other things on the fact that the consent form was signed after watching the videotape but before talking to the physician. The jury believed this was designed to encourage patients to commit to the procedure before learning of the risk from the physician.

Another pitfall in the informed consent process is showing videotapes after dilating drops have been administered. Patients can later claim the drops prevented them from clearly seeing the videotape. Ophthalmologists should communicate to ancillary personnel the importance of showing the videotape priorto dilation. If dilating drops are started before the patient views the video, the RK candidate should be brought back at a later time to view the video.

Some patients who sue their surgeon later allege they really had no personal incentive for having RK surgery, claiming their decision to have corrective surgery was based solely upon the recommendation of their ophthalmologist. An Arizona ophthalmologist, who was retained as an expert witness in a case where this claim was made, suggests that surgeons have prospective RK patients either complete and sign a prepared checklist of reasons for surgery or write in their own words why they want to have surgery. This type of documentation, signed by the patient, helps refute later claims that the patient had no personal reasons for choosing surgery.

Patients should be offered a signed and dated copy of the written informed consent form. The form must include details concerning the procedure’s side effects. Potential risks should be specifically discussed by the ophthalmologist with the patient. The physician must document in the medical records that the informed consent discussion took place. If the ophthalmologist relies only on signed consent forms and does not document the consent discussion, the patient could later allege that he or she signed the forms without really understanding them.

A properly signed, witnessed and dated consent form, especially when accompanied by a handwritten entry in the medical record, can be a powerful ally in the courtroom. When faced with a contemporaneous chart entry documenting the physician’s discussion of the risks specific to the patient, few plaintiffs have been able to recover for lack of informed consent by claiming they did not understand or take the time to read the consent form.

One plaintiff, an attorney from a well-known Denver firm, when confronted on cross-examination with the consent form passage “I understand that my vision may be made worse as a result of the surgery,” tried to salvage his claim by saying he did not understand how his vision could be made worse. The jury was not impressed with his “loophole” and returned a verdict for the ophthalmologist on this and other allegations in the claim.

Effects of Advertising on Informed Consent

The adverse impact of advertising on the informed consent process cannot be overemphasized. This is especially true when it concerns advertising and marketing of RK surgery. Nobody with vision problems can ignore advertising claims like the following taken from an actual ad for RK: “FREEDOM FROM GLASSES OR CONTACTS…IT TAKES LESS THAN 30 MINUTES AND THERE IS NO PAIN…YOU SEE IMMEDIATELY.” If a lawsuit is ever filed against the ophthalmologist who used this advertisement, the defense attorney will find it difficult to defend the ophthalmologist if the patient did not “see immediately” or had “pain” following surgery.

The largest jury verdict against an ophthalmologist in an RK case was awarded in California and exceeded $5 million. The plaintiff contended that the ophthalmologist said on television that the procedure was “100% successful,” that the advertising and personal assurances regarding the safety and effectiveness of the surgery were misrepresented, and that the physician failed to obtain informed consent. Although the patient had in fact signed a multi-page informed consent form reviewing the procedure’s risks, the jury determined that the ophthalmologist’s representations on television and his advertising claims of 100% effectiveness outweighed the force and effect of the signed consent form.

Many people look askance at any advertising by physicians, and are likely to examine the message with a very critical eye. A jury may be less sympathetic to a physician who advertises, perceiving the physician to be more like a business or salesperson than a caring, qualified health professional. Furthermore, unless the surgery took place before the advertising started, all plaintiffs can and will claim they were influenced by the glowing promises of an ad campaign. Since it is virtually impossible to prove a claimant did not see the ads, most courts will find the advertising to be relevant and admissible at trial. The plaintiff’s attorney will subpoena, and ultimately obtain from the media consultant, all print, radio and television ads that could possibly have been seen or heard. The text will be scrutinized for anything that could be interpreted as an unreasonable promise or guarantee in the eyes of a layman.

Does the copy promise “freedom from contacts or spectacles,” or tell readers or listeners to “throw away your glasses”? Neither the attorney nor the jury will overlook the conflict between this seductive message and the more somber consent form telling the patient that the “results cannot be guaranteed” and “you may need glasses or contacts after surgery.” Before approving any ad copy, the ophthalmologist should mentally place him or herself on the witness stand with a copy of the text in hand, explaining to a jury why the representations are accurate and consistent with the message the patient received in the examining room. If this mental picture makes the ophthalmologist uncomfortable, the ad should be rejected.

Even if the patient ultimately receives a thorough discussion of the risks, jurors will not look favorably on a professional’s use of hucksterism to lure patients. One panel of jurors in Colorado, after awarding a substantial verdict to a plaintiff with a marginal claim, cited misleading advertising by the defendant-ophthalmologist as a decisive factor.

Physician Training and Technical Surgical Issues

If a claim goes to trial, it is important that the surgeon be able to demonstrate that he or she obtained the proper training and necessary skill to perform RK surgery, either through a residency training program or a formal clinical hands-on laboratory course. Following this course, the surgeon should observe or assist an experienced RK surgeon with several cases. OMIC strongly recommends that its insureds also obtain experience on human cadaver eyes and be proctored for their first three to five cases.

In support of the value of proctorship, a study conducted at the University of California, Los Angeles Department of Ophthalmology showed that a beginning surgeon who operates under the supervision of an experienced refractive surgeon can obtain excellent results with radial and astigmatic keratotomy.¹

Inadequate training is difficult to defend in a courtroom when a poor outcome is the result. While jurors understand that all physicians must have their first RK patient or their first 20 surgeries, they expect the patient to be told if the surgeon is inexperienced. They also expect the surgeon to be particularly conservative and cautious until a greater degree of proficiency is attained. For instance, inexperienced RK surgeons should consider referring out or deferring surgery on higher myopes or difficult astigmatic cases until they have more practice with the procedure and are more knowledgeable in how the patient’s vision is likely to respond to their technique.

Jurors respect the skill and knowledge that come with experience in performing RK surgery. In one trial, several jurors commented that they regarded the defendant as being the true expert in the courtroom because he had far more surgical experience with RK than did any of the plaintiff’s expert witnesses. In another lawsuit a Colorado jury believed the defendant acted properly in performing a difficult RK surgical plan, largely because of his extensive experience.

Many lawsuits, however, have resulted from surgeons “pushing the envelope” with innovative techniques to enhance the surgical result. While medical knowledge cannot advance without innovation, the physician must exercise caution before proceeding. The patient should be informed of the innovative nature of such a technique, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Other options should be discussed and the patient should be encouraged to seek a second opinion before proceeding with an innovative technique. This discussion should be well documented.

In addition to proper training, the RK surgeon must invest in proper equipment. One legal claim arose from a case in which the patient suffered a substantial overcorrection, leaving her hyperopic. The ophthalmologist defended his operative plan, which seemed likely to result in overcorrection, by pointing out that it came from a widely used computer program for predicting RK outcome. Unfortunately, the program was outdated and its recommendations likely were based on less efficient equipment and techniques that produced less correction. The ophthalmologist apparently had attempted to economize by copying an older program from a colleague, rather than purchasing the updated program that was offered at the RK training session he attended. This false economy turned out to be quite costly for both surgeon and patient.

Patient Selection

Failure to adequately screen surgical candidates can easily result in claims from unhappy patients. Patients have sued in cases with an objectively good result because of unrealistic expectations about what surgery could do for them. Preoperative evaluation of the patient from a clinical and psychological standpoint is essential prior to RK surgery.

Various refractive outcomes (both over- and under-correction) should be demonstrated to the patient during the informed consent process. This allows the patient to better understand the possible levels of correction that may be achieved with surgery and to determine whether this meets expectations. The need to wear spectacles to correct presbyopia must be emphasized to every patient undergoing RK. Patients also must understand that contact lens wear probably will be more difficult and may not be possible following RK to correct a remaining refractive error.

A history of the patient’s refractive stability should be obtained. Never rely on patient’s assurances that their refractive error has remained “stable.” Make every effort to obtain and compare previous eye exam records. Keep in mind that an unstable refraction may indicate undiagnosed diabetes. RK is contraindicated in cases where the refraction has not shown reasonable stability over the 12 months prior to surgery.

Most patients assume they will be part of the majority of patients who are satisfied with RK surgery. One psychological study of patient satisfaction found 70.5% were extremely satisfied, 14.2% were somewhat satisfied, and 15.3% were somewhat or extremely dissatisfied.² In another study of RK patients, 48.5% indicated they were very satisfied, 42% indicated “average” satisfaction, and 9.5% indicated dissatisfaction.³ A third survey of 593 patients found 73% percent were very satisfied, 22% were moderately satisfied, 1% were neutral, 3% were somewhat dissatisfied, and 1% were very dissatisfied.⁴

However, when discussing the high percentage of satisfied patients, the ophthalmologist must temper the enthusiasm of the overoptimistic patient undergoing the procedure with the fact that some people are not satisfied. If the operation goes badly, the result can be a very unhappy patient. Ophthalmologists who subsequently treat patients suffering from poor uncorrectable vision or other side effects of RK surgery state that reports of the procedure’s excellent success rates do not mollify these patients.

Unrealistic expectations can arise not only from overly optimistic advertising or poor informed consent discussions, but sometimes simply may be the result of a depressed or hostile personality. In one case, a patient with a history of clinical depression focused only on the usually minor side effects of RK surgery: star bursts, glare and fluctuations in vision. Despite the good result achieved from surgery (20/30 uncorrected), this patient was convinced his vision was ruined. With something as subjective as “good vision,” the patient’s perception of the result is as important as any objective test.

Patients with alcohol and substance abuse problems are at greater risk of a poor result, not only from the nutrition and health problems often seen in these situations, but also from poor compliance following surgery. Failure to take meticulous care of surgical incisions can result in far greater corneal scarring, fluctuations in vision and infection. Patients who appear unable to care for themselves are poor candidates for an operation that requires conscientious post-op use of antibiotic and steroid drops, careful hygiene and forbearance from the common habits of eye rubbing. Your office staff is likely to have spent a good deal of time with the patient. Listen to them if they express concerns about the patient’s mental stability or personal habits that may lead to postoperative problems.

Litigation Issues

Although RK surgery is considered by some to be controversial, in most lawsuits it is not the procedure itself that is on trial, but the use of unusual technique, improper execution or lack of informed consent. More than likely, if a plaintiff’s experts are qualified to comment on RK care, they are probably performing RK surgery themselves and are not ideologically opposed to it.

RK surgery can be successfully defended in court, provided the surgeon approaches the procedure responsibly and with concern for the patient’s ultimate well-being. To help ensure that claims against policyholders are defensible, OMIC’s guidelines for keratorefractive procedures incorporate the risk management principles discussed in this article. Ophthalmologists who are considering performing RK surgery are encouraged to contact OMIC’s underwriting department for further information on RK coverage. Underwriters are available to answer coverage questions from 7 a.m. to 4:30 p.m. (Pacific Time) at 1-800-562-6642, extension 639.

Notes:

1. Friedburg, et al. Radial and Astigmatic Keratotomy. Ophthalmology. 1993;100(5):746-751.
2. Powers MK, et al. Ophthalmology. 1984;91:1193-1198.
3. Bourque LB, et al. Arch Ophthalmology. 1986;104:356-363.
4. Chiron IntraOptics 1992.

When Lawyers Come Beckoning with the Color-Coded Maps

By Dean C. Brick, MD, Argus, October, 1994

As use of corneal topography increases, a risk management question arises: will ophthalmologists have to invest huge sums of money to protect themselves from the lawyer carrying the beautiful color-coded maps, who will try to persuade a jury that the results of treatment or surgery would have been different if this new technology had been used?

Background

For years ophthalmologists used standard keratometry to measure corneal curvature. Ophthalmologists who performed corneal transplantation realized the deficiencies of standard keratometry in evaluating patients after penetrating keratoplasty and became adept at interpreting Placido disc images or photokeratoscopic images. Recently, however, qualitative measurements of the cornea obtained by these instruments have been surpassed by quantitative corneal measurements with computer videokeratoscopes (CVK).

Most of the CVK systems currently available are based on Placido disc imaging recorded by a video camera and analyzed by computer software. Newer systems that measure the surface elevation of the cornea rather than analyze the Placido image are being developed, but the advantages of these newer systems have yet to be determined.

Quantitative corneal mapping has increased ophthalmologists’ knowledge of corneal shape and how to change it, primarily when performing refractive procedures. It has opened up new ways to diagnose corneal diseases, treat corneal problems, and fit contact lenses. In the future, corneal mapping may prove useful for predicting visual acuity before and after refractive surgery and for determining the refractive procedure most beneficial for a particular patient.

The Corneal Specialist

Corneal specialists appreciate topography for diagnosing pellucid marginal degeneration, keratoglobus, keratoconus, irregular astigmatism and other corneal diseases. Many of these conditions can be diagnosed by more conventional means; however, the CVK enables the physician to accurately follow the progression of the disease, assists in fitting contact lenses when these conditions are present, and aids in surgical planning and postop evaluation and management. The CVK also helps the corneal surgeon evaluate postoperative penetrating keratoplasty patients, including diagnosing the astigmatism axis and type, suture removal and adjustment, and secondary procedures to decrease astigmatism.

In many instances, CVK has not yet been proven to be superior to other clinical methods, but its increasingly widespread availability and published effectiveness is boosting its popularity. From a risk management standpoint, it seems prudent for ophthalmologists to use CVK in the diagnosis and management of corneal disease in which it has been shown to be effective, especially when it is available in the community.

The Refractive Surgeon

CVK is frequently used by refractive surgeons. Although corneal topography has not yet proven itself to be superior in planning primary radial keratotomy procedures, it is indispensable in other ways. It is effective in preoperative screening for diagnosing keratoconus and for recognizing asymmetric astigmatism. It also has been helpful in diagnosing “forme fruste” keratoconus. Although it is not known whether these patients respond differently to refractive surgery, the ophthalmologist should present this information during the informed consent discussion so patients with “forme fruste” keratoconus are not unpleasantly surprised if a complication arises.

CVK also has been shown to be effective when following patients in whom rigid or gas permeable contact lenses have been discontinued prior to refractive surgery. CVK has shown that the time required for the cornea to stabilize after contact lens removal is quite possibly much longer than commonly thought. Following the refractive surgery patient out of contacts until the topography stabilizes helps prevent postoperative surprises. It also allows for preoperative recognition of nonorthogonal astigmatism and helps with surgical planning.

Postoperatively, CVK assists in evaluating RK, AK and PRK patients. After RK and/or AK surgery, shallow or short incisions may show up as areas of less flattening. Using topography to find this condition allows for more accurate planning of secondary procedures. After PRK, topography has been useful in detecting central islands, recognizing and following regression, identifying eccentric ablations, and diagnosing irregular postop astigmatism.

From a review of the literature, it does not appear that topography has become “standard” when performing refractive procedures. However, this standard may change as more comprehensive studies are completed and the price of instrumentation drops, making it more available.

The General Ophthalmologist and the Cataract Surgeon

The general ophthalmologist and the cataract surgeon use CVK less frequently. It may be used to assist in contact lens fitting, but it has not proven superior to other methods. Similarly, it may help evaluate the corneal astigmatism of preoperative cataract patients, allowing the surgeon to plan wound construction and location. However, traditional methods of evaluating astigmatism in cataract patients also have proven effective over time. In the future, topography may help improve IOL power calculations; however, for risk management purposes, use of the CVK does not appear to have an impact on the general ophthalmologist or cataract surgeon at this time.

Conclusion

The role of computerized videokeratography in the practice of ophthalmology is evolving with almost every published article. Corneal specialists who perform refractive surgery should stay abreast of the published studies regarding the use of corneal topography and its effectiveness in diagnosing and treating diseases. Keeping current is important primarily to help ophthalmologists determine what is in the best interest of their patients, but it also may afford protection if confronted by the lawyer with the color-coded maps.

Untruth and Consequences (Complications of RK Surgery)

 By Karen W. Oxford, MD

Argus, October, 1995

Open and honest communication is the foundation of good patient relations and a prophylaxis against malpractice claims and lawsuits. The following case study illustrates the serious consequences that can result when there is a communication breakdown between ophthalmologist and patient.

Case Study: Bilateral Simultaneous RK Enhancements

A 38-year-old man underwent bilateral simultaneous radial keratotomy (RK) enhancements. Only the right eye was patched after the procedure and on the first postop day, the patient was told by another ophthalmologist that his right cornea had been perforated during the enhancement and the wound was leaking. The original surgeon did not examine the patient postoperatively and had not mentioned the complication to him after the surgery. A technician inserted a collagen shield and the patient was started on hourly Ciloxan.

On the second postop day, the wound continued to leak and cells were noted in the anterior chamber. The ophthalmologist who had examined the patient the previous day informed him of the possibility of infection and administered a subconjunctival antibiotic injection. The patient was sent home with instructions to remove the patch from his right eye after several hours. Upon removing the patch, he looked into the mirror and was shocked to see a large amount of conjunctival swelling and hemorrhage extending over the lower eyelid and covering the lashes.

The patient immediately called the second ophthalmologist’s office and was connected with the answering service. He explained the urgency of his problem and was told that the doctor on call would call him back. An hour later, the on-call doctor finally returned the patient’s second call and told the patient there was nothing he could do for him. He suggested that the patient try to get in touch with the surgeon directly, and then he hung up on him.

Meanwhile, his wife had contacted a fourth ophthalmologist, who examined the patient within 20 minutes of the call and diagnosed a corneal perforation with persistent wound leak and a large subconjunctival fluid accumulation. This ophthalmologist explained the situation to the patient in detail, including the risks, benefits, and alternative treatments for his condition. The patient declined suturing of the wound in hopes that the leak would spontaneously heal. The eye was patched and follow-up was scheduled for the next day.

On postop day three, re-examination by the fourth ophthalmologist showed a persistent wound leak. The physician applied a bandage contact lens and urged the patient to consider having the wound sutured closed. He was given the alternative of contacting his surgeon and having her perform the surgery at no cost since this was a complication of the enhancement procedure.

The patient saw the surgeon later that day in her office. During the examination she stated that the leak was really “just a pinpoint” but that a collagen shield would be placed as a preventive measure. The patient was brought into an operating room in the office and prepped for insertion of the shield. When the patient asked why all of this was necessary since the first collagen shield had been inserted by a technician who had not even washed her hands, the surgeon ignored the question and proceeded to insert the collagen shield. Angry that the ophthalmologist was not addressing the seriousness of his eye condition, the patient refused further patching.

On postop day four, the patient returned to see the fourth ophthalmologist, who noted a persistent wound leak and scheduled the patient for surgery. At the time of the surgery, the wound opening measured 4 millimeters in length and required two sutures to stop the leaking.

Risk Management Commentary

Initially, the surprise element sparked the patient’s anger and frustration. According to the patient, at no time during the informed consent process did the surgeon discuss the possibility of perforation, infection or loss of the eye. Furthermore, when the patient experienced a complication of surgery, this information was withheld from him. The surprise of bad news was further compounded when a third party communicated this information because the surgeon had failed to examine the patient postoperatively. The on-call physician’s failure to respond to the patient in a timely manner only inflamed the situation by adding a sense of abandonment to the patient’s feeling of surprise and anger.

This case might have been handled to the patient’s satisfaction if he had been properly informed of the risks of RK at the outset, and if the surgeon had been truthful about the situation after complications did arise instead of dismissing the patient’s concerns. The untruth led to consequences: The patient called his attorney.

Informed Consent for Refractive Surgery

By Richard L. Abbott, MD

[Refractive Eyecare for Ophthalmologists, May/June 1998]

We often talk about “the” informed consent as if it were a single document that patients sign prior to undergoing a procedure like refractive surgery. A much more valuable way to envision informed consent is as a process that begins when the patient receives any kind of information about the procedure from the physician’s office. Whatever patients subsequently learn from the practice becomes part of the process of informed consent.

The actual form that the patient signs is just the final step in the process. Most courts will find that all those other pieces of information that patients receive including marketing materials, videos, and patient information brochures are admissible as evidence as part of the informed consent.

The Informed Consent Document

The actual informed consent document that patients sign must cover four basic elements:

• Risks associated with the procedure
• The benefits of the procedure
• The complications of the procedure
• Alternative treatments

In addition, the informed consent should have some background information on the procedure and explain what happens in the procedure. These should all be presented in language that the layperson can reasonably be assumed to understand.

The informed consent document for refractive surgery should include a discussion of the advantages of one procedure vs. another (e.g., laser in situ keratomileusis [LASIK] vs. photorefractive keratectomy [PRK]). Important subsidiary issues like bilateral simultaneous surgery vs. sequential surgery also have to be aired. In each case, the advantages and disadvantages to the patient need to be spelled out clearly. The document should present the kind of factual information that will allow the patient to make as informed a decision as possible.

Risks

In refractive surgery, the greatest risk to the patient is that the results of the surgery will not meet his expectations. The procedure isn’t perfect, and wound healing isn’t perfectly predictable. Therefore, patients must be clearly advised that there is some uncertainty as to the outcome of any refractive surgery.

Even if a high percentage of patients are 20/20 following a procedure, there is no assurance that a given patient will obtain that (or any other) result. Patients must know and accept that outcomes are not guaranteed.

Failure to achieve an expected outcome is the greatest risk of refractive surgery. Some of the other relatively common risks that must be covered in an informed consent document are: undercorrection, overcorrection, fluctuating vision, glare, astigmatism, halos, and loss of perceived contrast in low light. These are all fairly common risks that must be explained.

More devastating outcomes, including loss of vision from infection or scarring, are very rare. It is not necessary to present these relatively unlikely possibilities in a frightening way; but patients do need to be informed that – just as they can be hit by a truck when crossing a street – there is a small, but not zero, chance of serious side effect or bad outcome.

LASIK adds some additional risks – tearing the flap, microkeratome failure, infections under the flap, epithelial ingrowth, etc. These are well known risks that can simply be listed, if the patient is to undergo LASIK.

“Off Label” Procedures

As of this writing, LASIK is still an “off label” procedure, and the patient needs to know that. Usually it is sufficient to include a simple statement to the effect that the doctor believes it is in the best interest of the patients to perform LASIK and that LASIK is allowed although it wasn’t specifically approved in the initial FDA review of the laser. This is not a major issue, but the patient should be made aware of it.

Like LASIK, simultaneous bilateral PRK has not received specific FDA approval. This fact should be made known to PRK patients considering a bilateral procedure. For bilateral PRK patients (and for bilateral LASIK patients as well), the informed consent should cover the advantages and risks of simultaneous bilateral surgery vs. waiting for the first eye to heal before operating on the second eye.

Support for Informed Consent

The informed consent document offers the surgeon some protection, even if it is the only thing that he can muster to show that there was a process of informed consent. But the protection will be greater if there is supporting evidence of a process that went beyond the single document, e.g., notes in the chart documenting a discussion between doctor and patient, or the results of a test taken after watching a video.

The protection offered by the informed consent document can be undermined, sometimes greatly, if the practice’s marketing or patient information materials don’t support it. Marketing materials that are very aggressive, that make claims that can’t be substantiated with facts, detract from the informed consent document. Even if the informed consent document is letter perfect and signed by the patient, its value will be diminished if other materials from the practice seem to contradict it. The refractive surgeon’s best protection is to pay attention to all steps of the process.

Timing

Patients need adequate time to consider the informed consent document. Handing the informed consent document to the patient a few minutes before the surgery isn’t enough. The patient should be able to take the document home, read it, perhaps share it with a spouse or friend, and then have an opportunity to ask the doctor questions about it prior to signing.

Giving the informed consent to an unprepared patient on the day of surgery doesn’t give the layperson time enough to grasp its contents. If there is an unsatisfactory result and the patient sues, the hurried circumstances under which the informed consent document was signed will come out in testimony, undercutting the value of the document.

Simply signing the document on the day of surgery is acceptable, if the patient has been given the document for review ahead of time (and this is documented). If the patient is to sign the document on the day of surgery, be sure that the patient is not sedated or dilated until after signing. In general, the patient should not be in any way impaired at the time of signing.

The Surgeon’s Role

Since one wants to be able to rely on it in court, the informed consent document should not be underplayed for the patient. Having a staff person hand the informed consent to the patient with words to the effect of “Please sign this document, it’s just a formality,” will diminish its value. If the risks were glossed over, or if the patient wasn’t given a chance to consider them, the patient may be able to make a credible case that she didn’t know before surgery that her unsatisfactory outcome was possible.

The doctor’s rejoinder that those risks were stated in the informed consent won’t carry much weight if the circumstances in which the document was given to the patient made it seem trivial. Again, informed consent is a process, every step of which should be attended to.

In the last analysis, informed consent is the responsibility of the surgeon. Videotapes, true/false tests, refractive surgery coordinators, and the like can all be important parts of the patient education process. But ultimately there needs to be a face-to-face meeting with the surgeon – even if it’s for a very short period of time. At this meeting the surgeon can ask: “Are there any questions that I can answer?”

Although it may be brief, the patient-surgeon meeting should be a real meeting in which an unsedated patient is free to ask questions. The face-to-face meeting should be documented. A first meeting in the surgery suite with the surgeon peering over the microscope to introduce himself and ask if there are any questions will not bolster the surgeon’s case in court.

Making Your Case

Most of the time nothing goes wrong, and most patients are happy with their result; but it takes just one incident to create a protracted period of difficulty for the refractive surgeon. Since the day-to-day reality is that little goes wrong, it is easy to let one’s defenses down. An ongoing process of informed consent, with clear documentation, should be built into the office routine. Good documentation of an adequate informed consent process makes defense of court cases much easier.

A surgeon’s case will get a strong boost if the chart has notes in the surgeon’s handwriting documenting his part in the informed consent process. This need not be elaborate. All that is required is a few brief sentences such as: “Reviewed informed consent document with patient. Patient understands. All questions were answered to patient’s satisfaction.” That plus a signature provides very useful documentation. If the discussion was more than cursory, a little note on how much time was spent will help, e.g., “15 minutes spent answering questions.”

What Can Weaken a Case?

Just as good documentation will support a case, overly aggressive marketing materials can torpedo it. It is hard to demonstrate that the patient should have been prepared for a less-than-desired result when the practice distributes literature that says things like: “You can throw away your glasses,” or “Guaranteed success.”

It is far easier to mount a good defense when the marketing material is straightforward, honest, and informative, and there is evidence of an educational process that took place over an adequate period of time. The absolute minimum time is probably 2 days. A 2-day process will give the patient at least one night to absorb the material and discuss it with a spouse or a friend. If on the next day the patient has an opportunity to ask questions of the surgeon prior to surgery, and if all this is carefully documented, the process is probably adequate.

Problems happen when the patient feels railroaded through the process with no real chance to understand the surgery or its risks. Unless there is a comanager handling the case, it is especially important that the patient have a chance to meet the surgeon and ask questions prior to the day of surgery.

A poor informed consent process is no liability when the surgical result meets the patient’s expectations. But when a patient’s expectations aren’t met, and the patient feels that there was no real communication with the surgeon, anger and lawsuits can happen. The rule is simple: poor communication leads to anger when there’s a bad outcome.

Comanagement

There are several important points about the comanagement situation. First of all, the patient must understand in advance how care will be divided. The comanaging ophthalmologist (or optometrist) must provide the pre- and postoperative care, but the refractive surgeon will be responsible for the actual procedure. The informed consent documents must clearly identify the participants and delineate their roles.

Although the refractive surgeon bears the ultimate responsibility for the surgery, both the surgeon and the comanaging ophthalmologist should have their own informed consent documents. The comanaging ophthalmologist’s document can be less elaborate than the refractive surgeon’s. The comanager’s document can just state his recommendation for the patient, his role in the process, what the procedure entails, and that the patient understands and accepts it.

The refractive surgeon’s document should detail the surgical procedure – including all the basic elements noted above – as well as describe her role and the role of the comanager. The informed consent process can be a joint effort between the refractive surgeon and the comanager. But each should have an informed consent document, and the patient should sign one document in each doctor’s office.

Even in a comanagement situation, the refractive surgeon needs to have a face-to-face meeting with the patient prior to their coming together in the surgery suite. At this meeting, the surgeon can introduce herself, be assured that the patient is adequately prepared, and ask if the patient has any additional questions. This meeting should take place prior to sedation or dilation. The informed consent can be signed at the end of the meeting.

Even though much of the informed consent process took place in the comanaging ophthalmologist’s office, the meeting between the patient and the refractive surgeon is important. The patient has to feel totally at ease with the surgeon, and the surgeon has to know that the informed consent done at the comanager’s office was thorough and well presented.

Conclusion

Informed consent is a very important piece of protection for refractive surgeons and comanaging ophthalmologists. But it is more than that. From an ethical and good practice point of view, as well as from a purely defensive standpoint, it’s important that patients be educated and understand what they are choosing.

A patient who has been brought into the decision process knows the risks and is less likely to believe he has reason to sue. The patients who sue are often the ones who feel abused by an uncaring surgeon who kept them in the dark. The very process of talking to the patients, of taking their concerns seriously, changes the atmosphere and reduces the chance of legal action.

Bilateral LASIK? Not on My Patients!

By James J. Salz, MD

Review of Ophthalmology, January 1998

All the supposed benefits of bilateral simultaneous LASIK surgery rest on big “ifs.” If the surgery and postop course go well, then the operation is more convenient for patients. If the procedure goes well, the surgeon can collect his fee all at once, and the number of follow-up visits is effectively halved. However, if there are complications, there is an excellent chance that those complications will occur in both eyes, not just one. If the patient manifests an unusual response to the surgery, it may well be necessary to perform reoperations in both eyes, not just one. If the patient is dissatisfied with the vision bilateral LASIK provides, he’ll be doubly unhappy and the surgeon could be doubly liable. In my opinion, that’s simply too many “ifs” to ever recommend bilateral LASIK surgery. I think after reviewing the facts, you’ll agree with me.

Complications

The biggest problem with bilateral procedures is the risk of complications. The problem is that if the complication occurs in one eye, there’s a very good chance it will occur in the fellow eye, as well.

Potential bilateral complications include:

• Bilateral infection. Though the risk for an infection with LASIK is probably around one in 1,000, there has already been a documented bilateral infection with the procedure,¹ and it stands to reason that bilateral procedures potentially increase the incidence. If the keratome or blade becomes infected during the first pass, the organisms will most likely be carried over to the fellow eye. This could leave the patient with significant central scars and vision loss in not just one eye, but in both eyes – an infinitely worse outcome.
• Interface haze. Texas surgeon Bobby Maddox and several others have reported cases of bilateral interface haze that begins as mild or moderate levels but worsens over two or three days, resolving only after several weeks of corticosteroids. In one series of 22 cases (most bilateral), all displayed this haze.² These patients’ best-corrected visual acuity varied from 20/25 to 20/200. After a several weeks of steroids, all but one patient returned to 20/20. This remaining patient was overcorrected to +2.00 D, with 20/30 best-corrected acuity. Though most of the haze resolved over time, the etiology and exact incidence of this unusual complication are unknown. Until we know more, it doesn’t seem prudent to put both eyes at risk.
• Retinal complications. LASIK patients can develop vitreous hemorrhage, central retinal artery occlusion, retinal hemorrhage or detachment. In one recent series, one patient out of 700 bilateral, simultaneous LASIK cases developed bilateral sub-macular hemorrhages, and his best corrected acuity deteriorated to 20/400 by the end of the first post-op day.³ Six months later, his best corrected acuity was 20/60 in both eyes. Other complications from this series included a retinal detachment and bilateral iatrogenic keratoconus from an improper thickness plate in the microkeratome.

In another series of bilateral LASIKs one patient developed bilateral retinal detachments and another developed extension of lacquer cracks into the macula on the first post-operative day.⁴

Visual Quality

Another problem with bilateral procedures is their inflexibility. We all know that some patients receive a good visual outcome, yet are still unhappy about halos, night glare, or vague visual symptoms. If the surgery is sequential rather than bilateral, the patient retains flexibility. If he’s unhappy with the result in one eye, it’s still possible to opt for glasses or contact lenses until advances like larger ablation zones, phakic IOLs and flying spot lasers are available. I’ve actually heard bilateral proponents say that one reason to do the eyes together is so the patient can’t compare the LASIK eye with a contact lens and be dissatisfied!

Predictability

Most bilateral LASIKs are probably more convenient for the surgeon and patient. However, we all know that different patients can respond differently to refractive surgery. While LASIK helps reduce the variability of the healing response, there’s still the possibility for an unexpected result. Surgeons and researchers are still modifying laser algorithms, and debating the importance of such factors as patient age, amount of myopia and room humidity. Also, individual variations in the cornea’s response to the laser still occur. When surgeons have the ability to modify the surgical plan based on the first eye’s response, better second-eye outcomes can result. This may eliminate the need for reoperations in the second eye, which can save time and effort for everyone involved.

Personal Risk

The final reason I avoid bilateral simultaneous LASIK is a pragmatic one: They increase the exposure to malpractice.

Remember, the typical LASIK patient is successful, with a good career and high earnings. If one of these individuals were to suffer permanent bilateral vision loss and successfully sue the surgeon, the physician would be responsible for the patient’s lost earnings over his or her lifetime. And, if the surgeon’s malpractice insurance didn’t cover the entire award, he would be responsible for the difference. In a California case, for instance, an RK patient who suffered from serious night visual disturbances, glare and visual fluctuations sued and won $5 million. If those same RK cases had been done sequentially, and the patient lost vision only in one eye, the impact on his future earnings would have been judged to be much less and the award would have been lower.

In the end, the decision to perform a bilateral simultaneous LASIK is a question of risk versus reward. The inability to learn from the first eye’s response and evaluate the patient’s satisfaction from the procedure, the potential for bilateral complications, and the possibility for a disastrous malpractice suit far outweigh any gains in efficiency.

For an idea of how the Ophthalmic Mutual Insurance Company views unilateral and bilateral LASIK, informed consent forms for both procedures can be found in the Appendix.

Notes:

1. Watanabe H, Sato Shigeru, et al. Bilateral corneal infection as a complication of laser in situ keratomileusis. Arch Ophthalmol 1997; 115:1593-94.
2. Spivack L. International Society of Refractive Surgery Symposium, Oct. 25, 1997.
3. Luna J. International Society of Refractive Surgery Symposium, Oct. 25, 1997.
4. Dodds R. Annual Meeting of the Argentine Society of Ophthalmology, Summer, 1996.