Charting the Perils of LASIK Comanagement

By Richard F. Callaway, Jr., Esq.

Mr. Callaway is a medical malpractice defense attorney and partner in the Houston law firm of Callaway & Brennig. He represents physicians and other health care providers in professional liability claims. The case study presented is not an OMIC case.

[Digest, Fall, 2002]

Beth, a middle aged woman, had worn glasses since she was six years old. She had tried every brand of contact lens on the market from RGP to extended wear without success. LASIK surgery seemed to be the answer to Beth’s problems. For ten years, she had seen an optometrist for her eye care. She genuinely liked the optometrist, so much so that she sought his care even after she sued him. Over the years, the optometrist had diligently compiled a significant patient history, including annual topographies of Beth’s corneas taken since 1995. Although he was not well trained in their interpretation, he used them to fit Beth’s contact lenses. His inability to interpret topographies was no uncommon given the widespread use of non-standardized topographies. Beth’s topographies were stored electronically on the optometrist’s office computer where they were available in sagittal, tangential, and numeric form, but they were not part of Beth’s chart.

Beth’s optometrist thought she was a good candidate for LASIK. No ocular surface diseases, such as keratoconus, had been detected in any of the optometrist’s regular slit lamp examinations. In 1998, he referred Beth to a highly regarded refractive surgeon for preoperative evaluation. Shortly before the appointment, the optometrist transmitted a brief patient history to the surgeon for the six months preceding the referral using a comanagement form provided by the LASIK center where the surgeon operated. He included Beth’s current refraction, information regarding past visual stability, and topographical maps in numeric form taken two weeks before the referral. The maps, one for each eye, were faxed to the surgeon’s office.

The refractive surgeon performed his own preoperative workup. He checked refraction, measure central corneal thickness, and obtained a history of ocular surface and systemic diseases. All tests were within normal range. Topographies were made using a refractive map and revealed a normal cornea. There was no clinical sign of ocular disease on slit lamp examination. Bilateral simultaneous LASIK surgery performed shortly after the preoperative evaluation. Postoperatively, the patient developed iatrogenic keratectasia. Although Beth’s vision was correctable to 20/25 with RGP, she was contact lens intolerant and eventually had to have bilateral corneal transplants. She soon found a lawyer.

Although Beth had orally consented to comanagement, she had not signed an informed consent acknowledging comanagement. Obviously unhappy with the results of LASIK, Beth sued the optometrist and refractive surgeon alleging, in part, negligent screening and failure to explain the plan to “comanage.” In her suit, Beth maintained she had never consented to and had never fully understood comanagement. There was no written informed consent to contradict Beth.

Worse, after suit was filed, the optometrist produced for the first time his complete patient chart containing more than 125 pages of Beth’s history and four years of successive annual color-coded topographical maps in both tangential and sagittal form. The refractive surgeon was shocked to learn this information existed. He was doubly shocked to see successive annual color-coded topographies in tangential and saggital form that were suggestive of an abnormal cornea. In fact, Beth had subclinical pellucid marginal degeneration that could not be detected in the surgeon’s preop workup. Now that suit had been filed, Beth’s entire history came into play.

Comanagement’s Impact on Litigation

In any LASIK lawsuit, comanagement is the simplest issue for lawyers to understand and master. So much has been written about the comanagement question by the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgeons (ASCRS) that lawyers now have a formidable armamentarium of issues and conflicts to exploit. While technical violation of the ethical suggestions and standards contained in the AAO/ASCRS Joint Position Paper may not equate to a violation of the standard of care, the danger is that the issue will get before the jury were the impact can be devastating.

Discovery regarding a patient’s allegations of comanagement leads, inevitably, to a veritable host of litigation horrors, including requests to produce information from patient files concerning fee allocations for the services rendered; inquiries into corresponding increases in comanagement fee and patient load; investigation of the practice protocols of the comanaging optometrist and refractive surgeon; depositions of principals and office personnel; evaluation of the quality and quantity of information in patient charts; and comparison of the surgeon’s comanagement fees with those of other surgeons in the are. The danger in any suit is that the refractive surgeon and the optometrist may be thought of as each other’s agent, as a single entity, or as joint venturers. Liability may attach to the refractive surgeon who has met the standard of care for no reason other than that the comanager is not knowledgeable about recognizing and treating post-LASIK complications or in interpreting preoperative topographies.

Comanagement Chart Audit

To determine the quality and quantity of information in comanagement files, Callaway & Brennig conducted an audit of 179 files from 48 optometrists who referred patients to refractive surgeons throughout 1998. Files were reviewed for information concerning 1) patient histories, 2) corneal topographies, 3) current and past refraction, and 4) preoperative examination. Many of the optometrist practiced in groups, but the groups appear to have had no standard procedures regarding the transmittal of information. Most comanaging optometrists had attended meetings, either individually or in groups, with the refractive surgeons with whom they comanaged. The surgeon’s desire to acquire “all relevant information” was emphasized at all times. Similar requests to furnish “relevant information” were made to office personnel. There was frequent mention of the need for records and conversations between the respective offices of the refractive surgeons and the comanaging optometrists.

Patient Histories

Only 17 of the 170 files contained any historical information about the patient. It has been estimated that the decision to undergo LASIK surgery is an eight-month process from initial consideration to the date of surgery, suggesting there is more patient history in the optometrists’ records than is being sent to the surgeons. The refractive surgeon cannot know whether records exist in a comanagement arrangement; all the surgeon can do is request records.

Corneal Topographies

Of 179 files, 71 (40%) contained topographical maps, 60 of which were of little additional diagnostic value to the surgeon because they were taken less than a month before LASIK surgery. Only 11 charts had corneal topographies more than a month old. More important, the vast majority of topographies (60) were faxed to the referring surgeon, rendering their color-coded features impossible to interpret when they emerged in black and white from the refractive surgeon’s fax machine. Only 10 charts contained color maps; from a historical perspective, these maps were not useful for comparison and detection of abnormality since they were taken within a month of surgery. Only one chart contained a color topographical map that had been made more than a month prior to surgery. Further complicating the problem, review of the files revealed that relatively few comanaging optometrists used topographical maps and scales that were consistent with those used for preoperative evaluation by the refractive surgeon.

One good preoperative topographical map, made by a well-trained person using a good machine, is almost always adequate to detect pathology. For that reason, a long series of topographical maps is not needed to detect most pathologies. The refractive surgeon should do a topographical map as part of the preop evaluation. Where the optometrist has also made topographical maps, those topographies should be transmitted to the surgeon before the preop exam in a form that is legible and with real diagnostic value.

Current and Past Refraction

While 163 files contained information on current, refraction, only 12 supplied information on past refraction. This is a serious omission because stable refraction is a fundamental requirement for LASIK. In the absence of historical information regarding past stable refraction, the refractive surgeon must depend solely on the patient’s word that his or her spectacle prescription has not changed within the last two years.

Preop Exam and Information Sharing

Half of the 179 charts contained information regarding a preoperative examination. It is probable that most optometrists performed slit lamp examinations, but they failed to document those examinations in information sent to the refractive surgeon. Compounding this lack of information sharing was the fact that bilateral simultaneous LASIK generally occurred within a week of the preoperative evaluation by the optometrist, which often was not enough time for the surgeon to receive the patient’s file form the optometrist.

No one can anticipate all the contingencies that might arise in a comanagement arrangement, but standardized procedures designed to ensure the transmittal of relevant patient information would improve comanagement, benefit that patient, and in the event of litigation, assist the comanager and counsel in defending claims of negligent comanagement.

Beth’s case was settled, so we will never knowing if the jury would have penalized the refractive surgeon for not know that a voluminous ten-year chart, including topographical maps stored on computer, existed in the optometrist’s office.

* * *

Protocol for Comanagement of Refractive Patients

The following SLEDOG Protocol for comanaging optometrists and refractive surgeons was developed by Callaway & Brennig

Simple mandatory procedures should be followed and shared with the comanaging optometrist. Each comanager should sign off on the following: refraction, central corneal thickness, pupil size (and how it is measured), ocular surface/systemic diseases, and topography. The refractive surgeon must see the patient for the first postop visit and be clear about the subsequent postop care to be provided by the optometrist.

Letters to comanaging optometrists should be written at the time of referral to request all relevant patient information. Such letters document that a system is in place to retrieve patient information.

Emphasize these simple mandatory procedures at meetings with comanaging optometrists.

Document your file. OMIC provides an informed consent form specifically for comanagement situations. The form simply requires the patient to acknowledge the comanagement arrangement.

Office personnel continuity should be maintained at all costs. Not only can a disgruntled former employee significantly strengthen a plaintiff’s case, but an office in turmoil is one that makes mistakes.

Give specific persons in your office responsibility for obtaining information about patients who have been referred by comanaging optometrists. While everyone should be generally aware of your simple mandatory procedures, designate one or two employees with specific responsibility for obtaining records. If a lawsuit is ever filed, their testimony will play better before the jury than the testimony of several employees, none of whom is completely familiar with your procedures and process.

Take the Risk Out of Contact Lenses

By Oksana Mensheha, MD

Argus, August, 1991

 It is estimated that approximately 25 million people in the United States wear contact lenses. Historically, ophthalmologists were cautious in prescribing this modality to correct refractive errors; they feared that hard lenses might cause possible damage to the eye. We now know that severe side effects rarely occur. But when they do, they may be quite serious and could theoretically lead to liability actions.

With so many people wearing contacts, familiarity sometimes leads to carelessness. This is particularly true of younger patients. As myopes under the age of 14 move into contact lens wear, there is a greater possibility for complications. Liability for contact lens fitting in children also is greater since children maintain a longer time period during which they can bring a suit against a physician. Parental consent should always be obtained before fitting patients under 18.

One of the primary risk management issues in contact lens fittings relates to the physician’s duty to disclose potential risks and alternatives. Side effects of contact lens wear differ for rigid and soft lenses. Problems with rigid lenses may include intolerance, corneal edema with ulceration, blurred vision due to poor wetting, keratoconus from lens warpage, irritation from chipped or broken lenses, corneal flattening, and an inability to see well with glasses. Problems with soft lenses may include irritation from solutions or protein build-up, giant papillary conjunctivitis and, rarely, severe and potentially blinding corneal infections such as those caused by Endamoeba histolytica.

One way to reduce potential liability exposure is through increased patient education activities. Infections complicating contact lens wear usually occur from a breakdown in hygiene. Hand washing must be carefully taught, and the use of sterile solutions to disinfect or clean lenses is a must. Enzyme tablets, for example, are to be dissolved only in sterile solutions, preferably in aerosol form, not in unsterile tap water nor in bottled distilled water.

To aid your patient and to protect yourself, be sure to provide each new contact lens wearer with written information on the risks and care of contact lenses. Personally instruct each patient about the hygiene of contact lens care and, before the lenses are purchased, explain the cost of fitting. Stress the need for routine follow-up care on a regular basis. It is of critical importance that you document in the patient’s record that such information was given. Some ophthalmologists have even developed an informed consent sheet that their contact lens patients must sign. Documentation-related problems continue to be the single most significant risk management concern in ophthalmic malpractice claims.

Infections from contact lenses have been shown to be a greater problem with all soft lenses, but particularly with extended wear lenses. Disposable lenses have not decreased this risk. Again, the risk here is greater for children who are more active, tend to play in a more contaminated environment, and are less likely to practice good hygiene with their lenses.

Patient anger and poor physician-patient communications contributed to one OMIC malpractice claim involving contact lens fitting. Although the patient was unable to wear her contact lenses, she was aggressively pursued for collection of the final portion of her bill. Communication between the ophthalmologist and patient broke down, and the patient felt her only recourse to get her doctor’s attention was to sue. A few patients do not tolerate contact lenses well even when they are fitted properly. Such cases are disappointing to both the doctor and the patient. The resolution of charges for unsuccessful results should be approached with kindness and compassion.

As a general rule, contact lens wear is popular and appreciated by many patients. Ophthalmologists should nonetheless be sensitive to those areas of potential liability relating to prescribing and fitting contact lenses. Communication with patients, disclosure of risks and alternatives, emphasis on proper hygiene and follow-up care, plus a compassionate approach to the problems of contact lens wear help lower physician liability and contribute to improving long-term patient-physician rapport.

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.