Life-sci lessons from LASIK

News that the FDA has cleared Advanced Medical Optics' new iFS Advanced Femtosecond Laser for eye surgery caught my attention because most of the recent news that mentions both FDA and eye surgery involves contention over LASIK, the technology that’s helped scores of people see clearly without glasses or contacts. The dispute centers, of course, not on the remarkable successes -- but on the small percentage of failures.

News that the FDA has cleared Advanced Medical Optics' new iFS Advanced Femtosecond Laser for eye surgery caught my attention because most of the recent news that mentions both FDA and eye surgery involves contention over LASIK, the technology that’s helped scores of people see clearly without glasses or contacts. The dispute centers, of course, not on the remarkable successes -- but on the small percentage of failures.

The debate reminds us that all technology is a double-edged sword. Automobiles are a leading cause of death, but on the whole their advantages outweigh their risks. Thankfully, work has already begun to mitigate LASIK surgery risk. Soon after the controversy began, BioOptics World reported on the American Society of Cataract and Refractive Surgery’s (ASCRS) decision to participate in a post-LASIK quality of life study with the Joint LASIK Study Task Force, which also includes the FDA, the National Eye Institute, and the American Academy of Ophthalmology. The American Academy of Ophthalmology’s board of trustees approved a proposal to co-fund the FDA driven study, and the ASCRS Foundation likewise committed funds to support it.

Daniel Schultz, head of the FDA's medical devices center, has said that identifying why complications occurred would help those considering LASIK make more educated choices. Studying these patients is “very, very high on the agency's priority list,” he stated.

Meanwhile, FDA advisers recommended revising the discussion of LASIK on the agency's Web site to make clear the risks, and suggested similarly rewording brochures given to patient-candidates.

Vision correction centers such as Toronto’s Herzig Eye Institute are likewise joining the effort. The institute has developed The Patient Guide to Custom Vision Correction to help patients understand and compare treatment options.

Stay tuned as BioOptics World follows this story -- and the effects of its outcome on the use of laser-based technologies for life sciences work.