After eight months of work to help a single patient with severe astigmatism, a Tucson surgeon’s persistence led to 20/20 distance vision without glasses.
TUCSON, AZ — When a patient’s astigmatism exceeded the range of every toric lens implant approved in the United States, Brock K. Bakewell, MD, FACS, did not settle for the closest option. The board-certified ophthalmologist at Eye Associates of Tucson spent eight months securing individual authorization from the U.S. Food and Drug Administration (FDA) to import and implant a higher-power lens made by Johnson & Johnson and available in Europe.
The patient, Navin Barot, MD, reached 20/20 distance vision without glasses within days of surgery.
During cataract surgery, the eye’s clouded natural lens is replaced with an artificial one. For patients with astigmatism, a toric lens can correct that distortion at the same time, often reducing or eliminating the need for glasses. The toric lenses approved in the U.S. provide enough correction for most patients, but Dr. Barot’s astigmatism exceeded their highest power.
“The easy path was to implant the strongest U.S. lens available and leave me dependent on glasses,” Dr. Barot said. “Dr. Bakewell took the hard path.”
Dr. Bakewell identified a lens with the toric power Dr. Barot needed and asked the FDA for permission to use it for him. According to Dr. Barot, Dr. Bakewell prepared the documentation himself and secured the two independent physician assessments of Dr. Barot’s eye condition required by the FDA. Single-patient requests like this are uncommon. The work is time-consuming, falls outside routine care, and is not compensated.
“I am a physician. I know exactly what that effort costs, that no one pays a surgeon to do it, and how rarely it happens,” Dr. Barot said.
Dr. Bakewell brought deep familiarity with both lens implants and the regulatory process to the case. He has participated in six FDA studies that led to the approval of multifocal, toric, and IC-8 Apthera lens implants, and he chaired the American Society of Cataract and Refractive Surgery’s Government Relations Committee from 2010 to 2019. He has practiced in Tucson since 1989, specializes in premium cataract and refractive surgery, and is a Fellow of the American College of Surgeons.
Dr. Bakewell performed the surgery at Wyatt Surgery Center, and is a partner at Eye Associates of Tucson, which has served the community for more than five decades and performed over 60,000 cataract surgeries. Within days, Dr. Barot was seeing 20/20 at distance without glasses.
“Skill is expected of a good surgeon. What sets Dr. Bakewell apart is his willingness to go far beyond what is expected when a patient’s outcome depends on it,” Dr. Barot said. “I recommend him without reservation.”
The FDA authorization applied only to this individual patient’s treatment and does not constitute general U.S. approval of the lens. Individual results vary. To schedule a consultation with Dr. Bakewell at Eye Associates of Tucson, call 520-888-6600 or visit tucson2020.com.