TAMPA, Fla. – Quite a few systemic conditions generally thought to make a patient ineligible for refractive surgery may not be contraindications after all. Joseph Stamm, OD, FAAO, of the University of Rochester Eye Institute and the StrongVision Refractive Surgery Center, attempted to debunk some of these myths Tuesday here at the Optometric Council on Refractive Technology meeting.
The Food and Drug Administration’s patient education booklet, which is recommended for all LASIK patients, is more than 10 years old. According to the booklet, patients should not have LASIK if they have collagen, vascular, autoimmune or autodeficiency disease, Dr. Stamm said. This includes rheumatoid arthritis, systemic lupus erythematosis, ulcerative colitis, Crohn’s disease, Graves’ disease and psoriatic arthritis. However, the literature says it is safe, he said.
A study by Alio and colleagues published in Ophthalmology in 2005 found no complications or reactivation of disease in patients with rheumatoid arthritis, lupus, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis and Behçets’ disease. “These people don’t seem to do any different than the rest of the population,” Dr. Stamm said. He polled the audience; about half said they would recommend LASIK for such patients.
Another study by Smith and Maloney published in the Journal of Cataract and Refractive Surgery in 2006 had similar results. This patient base also included ulcerative colitis, Reiter’s syndrome, Graves’ disease and fibromyalgia.
Cobo-Soriano and colleagues published a study in Ophthalmology in 2006 that concurred. However, these researchers found poorer predictability in refractive outcome in autoimmune patients, Dr. Stamm added.
One laser manufacturer specifically states that the safety and efficacy of the laser has not been established in patients taking Imitrex (sumatriptan succinate, GlaxoSmithKline) or a history of keloids, Dr. Stamm said.
“Vision changes” are listed as an adverse effect in the Physician’s Desk Reference, he said. “Early research on Imitrex showed dry eye and epithelial problems in dogs given six times the human dose,” he said. “According to the PDR, dogs receiving sumatriptan developed corneal opacities and epithelial defects after being given 10 times the human dose.”
Dr. Stamm polled the audience: “You have a patient with a history of migraines. The triggers are stress and bright lights. You’re going to take a patient and put them under stress and incredibly bright lights. Who will tell this patient not to take his or her medications?” A few audience members raised their hands.
Hardten and colleagues, in an article published in the Journal of Refractive Surgery in 2005, said the rate of epithelial defects was similar between control patients and those taking sumatriptan. They concluded that there was no reason to stop the medication before LASIK.
The same laser manufacturer also specifically stated that the safety and effectiveness has not been established in patients with a tendency to form scars, Dr. Stamm said. He polled the audience, asking how they would handle a patient with keloids who wanted refractive surgery. Most would not recommend PRK, but quite a few said they would recommend LASIK. “The literature says it’s safe,” Dr. Stamm said.
Tanzer and colleagues in 1998, Artola and colleagues in 2006, and Cobo-Soriano and colleagues in 2006 all concluded that a successful LASIK outcome can be expected in patients with a history of keloids. “We’ve done patients with keloids,” Dr. Stamm said. “I discuss what’s published with these patients and they seem comfortable. There have been no problems.”
Patients have been advised to let their doctors know if they have diabetes when considering a refractive surgery procedure. “Their refraction could be unstable if their blood sugar is unstable, corneal wound healing could be affected, and corneal sensitivity may be decreased,” Dr. Stamm said. “I really want to know what their blood sugar is like, if they are stable, how long they have been diabetic, whether they’re on orals or insulin or if they failed on orals. The last thing I want to do is treat a cornea with something going on in the back of the eye.”
He once again polled the audience, asking attendees to consider a patient with controlled diabetes and no ocular problems. Many audience members said they would treat this patient.
One retrospective chart review in 2005 showed a higher retreatment rate, Dr. Stamm said. This may be a plausible contraindication. “In my practice, if I see anything in the retina, I say no,” he said. “That indicates diabetes for a long time.”
Attendees also debated the use of refractive surgery in women who are pregnant or nursing. “This has not really been discussed in the literature,” Dr. Stamm said.
A general consensus in the audience was to wait 3 months after breastfeeding has been stopped. One audience member specified two normal menstrual cycles and no breastfeeding. All agreed they would not treat a woman who is breastfeeding.
Dr. Stamm concluded by advising attendees to look at patients as the individuals they are. “If you give them the FDA booklet, you have to explain it to them,” he said. “If they have additional risk, add that to their consent.”