Risk Management



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.
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