Over the past 3 decades, the field of refractive surgery has evolved into a subspecialty with finely tuned, computer- and laser-assisted procedures that play an important role in the surgical armamentarium of today’s ophthalmologists. As the spectrum of indications for refractive surgery has grown, so has the prevalence of patients with concomitant known ocular or systemic diseases who wish to undergo these procedures.
During this period, many patients excluded from the original United States Food and Drug Administration (US FDA) clinical trials have been successfully treated with refractive surgery, and some formerly absolute contraindications have been changed to relative contraindications. With increased experience, laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) have been performed safely and effectively in patients with ocular or systemic diseases. Nevertheless, the use of these procedures on patients whose conditions would have excluded them from participation in the original FDA protocols is considered off-label. Performing off-label surgery is neither illegal nor medically incorrect if, in the surgeon’s judgment, the benefit of a surgical procedure outweighs the potential risk to a patient. However, it is the surgeon’s ethical, legal, and medical responsibility to explain the concept of off-label surgery to the patient, to determine whether the procedure meets the standard of care in the community, and emphasize to the patient the unknown risk associated as a result of using an off-label non–FDA-approved protocol.
In higher-risk patients, unilateral surgery may offer the advantage of providing assurance that one eye is doing well before surgery is performed on the second eye. In addition, when deciding whether a patient with connective tissue disease or immunosuppression is an appropriate candidate for refractive surgery, the surgeon may find that consultation with the patient’s primary physician or rheumatologist provides important information about the patient’s systemic health.
The process of consent should be altered, not only to inform the patient, but also to document the patient’s understanding of the additional risks and limitations of postoperative results associated with any coexisting ocular or systemic diseases. The refractive surgeon may choose to supplement the standard written consent with additional points to highlight specific concerns. The ophthalmologist should assiduously avoid the highrisk refractive surgery patient who volunteers to sign any preoperative consent because “I know these complications won’t happen to me.” Such patients have not heard or understood the informed consent discussion.
American Academy of Ophthalmology Refractive Management/Intervention Panel. Preferred Practice Pattern Guidelines. Refractive Errors & Refractive Surgery. San Francisco: American Academy of Ophthalmology; 2013. For the latest guidelines, go to www.aao.org/ppp.
Bowers KS, Woreta F. Update on contraindications for laser-assisted in situ keratomileusis and photorefractive keratectomy. Curr Opin Ophthalmol. 2014;25(4):251–257.
Excerpted from BCSC 2020-2021 series: Section 13 - Refractive Surgery. For more information and to purchase the entire series, please visit https://www.aao.org/bcsc.