Risk Management

New Surgical Advances Come with Liability Risks

 By Daniel A. Long, MD, and Monica L. Monica, MD, PhD

Argus, April, 1996

Using foldable lens implants, ophthalmologists can perform true small incision surgery with less induced astigmatism, less postoperative inflammation, and a speedier return of visual acuity. Corneal tunnel phacoemulsification with topical anesthesia further enhances the benefits of this implant. However, along with these clinical advancements arise risk management issues concerning patient selection, informed consent and surgical training.

Patient Selection and Education

A patient undergoing corneal tunnel phacoemulsification with topical anesthesia should be informed that this is a relatively new technique presently used by only a minority of ophthalmologists. Encourage the patient to weigh this information against the overall clinical benefits experienced by other patients who have undergone this technique. Document in the chart the entire informed consent discussion and note any educational materials the patient receives. This documentation will make it difficult for a patient to later claim that he or she was unaware this was a relatively new technique.

Most postoperative problems with silicone lenses can be avoided with proper patient selection. Overall clinical experience is good, but a few reports have found increased postoperative inflammation. Use these implants with caution in patients with advanced diabetes mellitus, exfoliation syndrome, uveitis, and possibly glaucoma since cell deposits on any implants may be worse if these conditions are present. If silicone implants are used, discuss the risks and advantages with the patient and note the discussion in the chart.

Avoid silicone lenses if a vitrectomy is likely after cataract surgery because visibility during the vitrectomy and gas-fluid exchange will be hampered by condensation of tiny vapor bubbles on the posterior surface of the silicone lens. Take this into consideration during the preop evaluation.

Training and Experience

New procedures can be broken down into component parts and learned in steps until the entire technique is completely mastered. Providing evidence of successfully mastering a step before moving on to the next one can help insulate an ophthalmologist from claims that he or she lacked the necessary training or experience to perform the new technique. Should a claim turn into a lawsuit, defense counsel will be able to elicit testimony from the ophthalmologist regarding his or her careful and methodical approach to training.

Corneal tunnel phacoemulsification with topical anesthesia is an excellent example. The authors have developed the following seven steps for a successful transition to this new procedure. Ophthalmologists should perform at least five cases for each step and more for any that are particularly difficult, such as step two.

  1. Change to a silicone lens.
  2. Change to a temporal location.
  3. Change to corneal incision.
  4. Eliminate traction sutures.
  5. Eliminate lid blocks.
  6. Change to subtenons injection.
  7. Begin topical anesthesia.

Whenever possible, observe and assist a more experienced surgeon who performs this technique. This helps weaken the plaintiff’s claim that the surgeon lacked proper training.

Finally, with any new technique, evaluate and adjust the postoperative regimen, if necessary. For instance, with topical anesthesia, pressure control is extremely important to prevent postoperative pain. Therefore, meticulously remove viscoelastic material and consider the use of intracameral acetylcholine, topical beta blockers and apraclonidine, and oral acetazolmide. Be particularly aggressive about pressure control in the glaucoma patient.


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