Hyperguides

Ophthalmology / Risk

Risk Management in Refractive Surgery

Christopher J. Rapuano, MD
Article

Christopher J. Rapuano, MD

Introduction

Refractive surgery has been steadily increasing in popularity over the past decade. Advances in technology and improvements in techniques have led to improved clinical outcomes. In turn, this has led to higher patient expectations. Generally, when reality does not reach expectations, people are disappointed. In medicine, when patients are disappointed, they often turn to the legal system for a remedy. This often leads to a malpractice claim against one or more entities in the refractive surgery process.1-3

High Patient Expectations

One factor in elevated patient expectations is marketing. Marketing, by definition, stresses the benefits of the product while minimizing the cost (risk). As laser centers and surgeons vie for a large piece of the lucrative refractive surgery market, the advertising often exaggerates the benefits and ignores the risks.

If patients believe in a billboard that indicated that they will never need glasses after undergoing refractive surgery, and the refractive surgeon does not explain that they will need reading glasses at some point, then disappointment may result.

Another factor in high patient expectations is the number of people who have undergone successful refractive surgery. Patients often have personal contact with happy patients. Unhappy patients are few and far between, and are often less likely to broadcast the fact that they underwent expensive cosmetic surgery and are not satisfied. Consequently, most potential patients have heard only success stories.

Patients may also believe in the advertisements they hear on the radio, see on television, and read in the papers - if they are unhappy after a surgical procedure, then someone must have done something wrong. They can sue and recover a lot of money.

The Basics

The only way to guarantee never being sued is to stop practicing medicine. An unhappy patient can almost always find a lawyer to take his or her case. A lawyer can almost always find an "expert witness" to criticize medical or surgical care that comes nowhere near malpractice. The following will discuss ways to minimize the chances of being sued, or at least being sued successfully.

The first rule is to do what is in the best interest of the patient. This may not be in the best interest of the surgeon, the laser center, the co-managing doctor or others, at least in the short-term. But in the long-term, it is difficult to be faulted if you did what was in the best interest of the patient. Often a small problem (which is not malpractice) is compounded by decisions aimed at "correcting" the first problem, at least for the surgeon or the laser center, but which are not in the best interest of the patient, thereby potentially creating malpractice.

For example, a surgeon creates a short laser in-situ keratomileusis (LASIK) flap. The exposed stromal bed was not large enough to perform the laser treatment. Instead of simply replacing the flap and not lasering, he attempted to lengthen the flap with a blade. That resulted in an irregular bed and decreased vision from irregular astigmatism, and a very unhappy patient (and possibly negligence).

The second rule is to document properly. Incomplete documentation is high on the list of problems malpractice defense attorneys face when attempting to defend a physician. In the courtroom, it is difficult to convince a jury that the physician actually did something when it is not documented.

The following are suggestions to reduce malpractice exposure related to refractive surgery.

Preoperative Examination

  • Consider personally confirming the refraction before surgery. This is not only a good final check, but it demonstrates to the patient that a surgeon cares enough to do it himself or herself.
  • Make sure the refraction is stable and document it. Make sure the patient is out of contact lenses for the appropriate period of time before the final refraction and document that it is stable. Both of these issues are clearly addressed in the indications for laser treatment from the laser manufacturers.
  • A careful slit lamp examination looking for anterior basement membrane dystrophy (ABMD) is important as it is a risk factor for epithelial problems with LASIK.4-6 Epithelial loosening and defects increase the risk of suboptimal results after LASIK. Patients with ABMD are not the best candidates for LASIK performed with a microkeratome. They might do better with photorefractive keratectomy (PRK) or epithelial-sparing surface ablation or LASIK with a femtosecond laser. In any case, the diagnosis of ABMD must be discussed with the patient, and the discussion needs to be documented.
  • Check pachymetry preoperatively. When considering LASIK surgery, make sure the residual stromal bed will have adequate thickness for the planned ablation. Adequate thickness is typically defined as greater than at least 250 microns and greater than 50% of the pre-operative pachymetry. Remember to use the ablation depth for the full correction, before adjusting the treatment using a nomogram, when calculating the residual stromal bed thickness. For example, if attempting to correct -10 D, the amount of central tissue removal for a 6 mm ablation zone was originally calculated (for PRK) to be approximately 120 microns. When LASIK was developed, the amount of refractive treatment had to be adjusted to get the correct result. Most surgeons were reducing the myopic laser input by 10%-15%. In this case, for LASIK, the laser would be programmed for -8.5 D. However, the amount of actual tissue removal would be close to 120 microns, not 102 microns, as the laser printout states for a -8.5 D treatment.
  • Check corneal topography pre-operatively. Be wary about treating eyes with inferior steepening with PRK. Be extremely wary of treating eyes with inferior steepening with LASIK. Topographic inferior steepening and thin residual stromal beds are risk factors for the development of ectasia after LASIK.7-9
  • Check the pupil size in dim illumination. While the exact role of pupil size in the development of night vision complaints remains controversial,10-12 the best way to avoid patient dissatisfaction is to discuss the issue pre-operatively. Whether a light amplification pupillometer (e.g. Colvard pupillometer), infrared pupillometer or simply a near card is used, the dim light pupil size should be documented in the chart. If it is on the large side, e.g., ≥ 7 mm, you should discuss this fact with the patient, along with its possibly being a risk factor for night vision complaints after refractive surgery. Your chart should reflect this discussion.
  • Check the patient's systemic medications. Isotretinoin (e.g. Accutane, Roche Pharmaceuticals, Nutley, NJ) and amiodarone (e.g. Cordarone, Wyeth-Ayerst, St. Davids, Pa) are listed as contraindications and sumatriptan (e.g. Imitrex, GlaxoSmithKline, Middlesex, United Kingdom) is listed as a relative contraindication to PRK and LASIK for the VISX (Visx Inc., Santa Clara, Claif) excimer laser, due to case reports of adverse results. Document the medications in the chart. If the surgeon and patient decide to proceed with surgery while on such medications, make sure this discussion is in the chart and that it is mentioned on the informed consent document too.
  • The concept of dry eyes and the possibility of dry eye symptoms after refractive surgery should be discussed with the patient. If the patient is concerned about dry eyes, additional testing, such as Schirmer's test or staining with lissamine green or rose Bengal, may be warranted. Pre-operative treatment, for example with artifical tears and/or cyclosporine, may also be desirable. Patients should understand that many patients experience dry eye symptoms after refractive surgery. The symptoms generally revert to baseline over weeks to months, but not always. Some patients have prolonged dry eye symptoms.13-15
  • The need for reading glasses to see objects up close immediately after surgery or in the near future should be stressed to all prepresbyopic patients. While presbyopic patients understand the reading glasses issue, they need to realize that the refractive surgery will not eliminate their need for reading glasses. It is amazing how many patients complain of needing reading glasses after refractive surgery for myopia. The concept of monovision also needs to be brought up with patients, even if you, as the surgeon, are not a proponent of it.16
  • While it is difficult for many patients to grasp, the "quality" of vision after refractive surgery may be better, the same or worse than with correction before surgery -- even with 20/20 Snellen visual acuity.17,18 Patients should be aware of this.
  • At some point there should be a discussion of several other topics including expected results for patients' refraction, chances of needing distance glasses and/or enhancement, slower recovery of vision for hyperopes than myopes, chances of decreased best corrected visual acuity and rare but severe decreased vision. Also alternative treatments, such as Intacs or phakic lens implants (where applicable), and the pros and cons of wavefront technology and whether to perform surgery on one eye versus both eyes the same day should be discussed.
  • The surgeon should personally review/discuss the benefits and risks of surgery with the patient and take time to answer all questions. This discussion should not take place while the doctor and patient are standing up to leave the examining room or are in the hallway. It also should not take place after the patient has received anti-anxiety medications (such as Valium). The patient must feel that the surgeon took the time and interest to address any special issues (e.g., large pupils or thin corneas) and patient concerns. Discussion of any special issues or concerns should be specifically documented in the chart.
  • While it takes some time, documentation in the chart in the surgeon's own handwriting of the important points of the pre-operative discussion specific to that particular patient means infinitely more than a patient's signature on a lengthy informed consent document.
  • Do not hesitate to see patients for another visit if the refraction, pachymetry, topography or other results are not of high quality and are not consistent. Patients will appreciate the fact that you are being careful and will generally be happy to return for a (free) visit to make sure all the tests are perfect before proceeding with surgery. A visit a few weeks before surgery to answer any remaining questions is never a bad idea, especially if there is a prolonged period between the evaluation and the surgery.

Intraoperative Issues

  • The surgeon should make as sure as possible that the laser and microkeratome are functioning properly. In addition, the surgeon should personally check that the treatment programmed into the laser computer is correct (i.e. correct numbers, correct patient). I have seen errors in number (5.0 D of astigmatism treated instead of 0.5 D), errors in axis (treated at 90° instead of 180°, doubling the astigmatism, instead of eliminating it) and even the wrong patient treated (treated for -3 D instead of +3 D), when the order of patients was changed on the day of surgery, resulting in a +6 D very unhappy patient.
  • If there is a significant complication during surgery on the first eye, DO NOT proceed with surgery on the fellow eye that day. There is a strong temptation to get the fellow eye seeing well so the patient does not dwell on the suboptimal result in the first eye. This desire can turn a bad situation (but not negligence) into a worse situation, and very possibly a malpractice action. I know of several cases in which a bad LASIK flap was created in the first eye. The surgeon proceeded with LASIK in the second eye and obtained a similarly bad LASIK flap. Although a bad result is not necessarily negligence, bad judgment combined with a bad result often is.

Postoperative Issues

  • Be honest with everyone -- the patient, his or her family, the technicians, and the laser center. Let them know if there was an untoward event during surgery or during healing. It is much better that they hear it from you than from someone else.
  • Do not hesitate to refer patients who are not doing as well as you or as they would like to a local expert whose opinion you trust. If you do not, the patients will refer themselves, and the expert may not be the one you would have chosen. In general, patients will appreciate your concern.
  • Do not abandon unhappy patients. The natural inclination is to avoid these "problem" patients. What surgeon wants to be reminded of his or her less than satisfied patients? Surgeons tend not to speak to them when they call and not to spend much time with them when they come for office visits. These are exactly the patients who need extra time. If necessary, schedule them as the last patient of the day, so no one feels rushed and you can address all their concerns. If you do not, be certain they will find a lawyer who will.
  • If an untoward event should occur, the physician should alert the risk management personnel of his or her malpractice carrier. They often have excellent advice related to the specific issue at hand. The laser center/hospital should also be notified of the event, if appropriate.

Conclusion

With expectations for refractive surgery as high as they are, some patients are sure to be disappointed. The better informed they are before surgery, the less likely they are to feel wronged and therefore the less likely they are to see a lawyer. The better surgeons perform their preoperative examinations and document their informed consent discussions, the less there will be for others to criticize with 20/20 hindsight.19

References

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  14. Toda I, Asano-Kato N, Hori-Komai Y, Tsubota K. Laser-assisted in situ keratomileusis for patients with dry eye. Arch Ophthalmol. 2002;120:1024-1028.
  15. Albietz JM, Lenton LM, McLennan SG. Chronic dry eye and regression after laser in situ keratomileusis for myopia. J Cataract Refract Surg. 2004;30:675-684.
  16. Goldberg DB. Comparison of myopes and hyperopes after laser in situ keratomileusis monovision. J Cataract Refract Surg. 2003;29:1695-1701.
  17. Bailey MD, Mitchell GL, Dhaliwal DK, Boxer Wachler BS, Zadnik K. Patient satisfaction and visual symptoms after laser in situ keratomileusis. Ophthalmology. 2003;110:1371-1378.
  18. Hammond SD Jr, Puri AK, Ambati BK. Quality of vision and patient satisfaction after LASIK. Curr Opin Ophthalmol. 2004;15:328-332.
  19. Rapuano CJ. Reducing the risk of lawsuits after refractive surgery. In: Wilson RP, ed. Yearbook of Ophthalmology 2002. Philadelphia, Pa: Mosby; 2002.