A multi-phase study designed to evaluate the potential side effects of LASIK eye surgery suggests that nearly half of patients experience some sort of visual complications following the procedure.
The findings of the new research were outlined by the FDA in an update posted this week to the agency’s LASIK information page.
According to the review by the federal health regulators, up to 45% of patients who undergo the laser eye surgery can expect some kind of vision problem, with many patients ultimately developing visual halos and experiencing difficulty driving at different times of the day. Many also develop severe dry eye and other eye complications.
These findings come following a probe launched by the FDA following concerns that the industry was painting too rosy a picture of LASIK outcomes, without actually having data on hand to outline the real-world risks.
LASIK Eye Surgery Concerns
LASIK is a form of eye surgery that uses a laser to improve a patient’s vision and reduce their need to wear glasses or contact lenses. During the eye surgery, a surgical instrument known as a microkeratome is used to cut through the top layers of the cornea to create a flap. A laser beam is then used to reshape the cornea for vision correction and the corneal flap is replaced.
In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP), which aimed to determine the percentage of patients who develop post-LASIK surgery difficulties.
The study used tools and questionnaires to assess visual symptoms patients were experiencing before receiving the correctional surgery and complications experienced following LASIK surgery, to identify changes over time and possible long term side effects.
When the study began, there was very little scientific data on certain patient reported outcomes (PROs), and in 2009 the FDA issued a warning letter about the use of misleading ads that do not warn patients about all of the potential risks. The agency issued another LASIK warning letter in 2011.
The results from the latest study indicate that up to 45% of participates who had no visual symptoms before surgery, had reported at least one visual symptom at three months following the LASIK surgery and some participates recorded having difficulty driving at night or in sunshine. The results further indicated that 35% of participants who had no prior complications had experienced halos within the first three months and 30% of the participants experienced severe dry eyes and other various debilitating vision symptoms.
The study also collected data from participants who were classified as “dissatisfied” with their correctional surgery for reasons such as experiencing double vision, ghosting, starburst, glares, and halos.
FDA officials say they hope the findings from the study will help the agency better refine the labeling risks associated with receiving LASIK surgery and will be incorporated into patient labeling guidance. In addition, they hope the results will also help spread the awareness of possible side effects and dangers following LASIK surgery.
Although rare, a number of patients have filed Lasik surgery malpractice lawsuits against eye surgeons over complications that were allegedly caused by a failure to follow the appropriate standard of medical care, most commonly involving problems that occur after a doctor fails to properly screen patients out as a potential candidate for the eye surgery.
The FDA has set up a special section of its website for consumers to outline the potential problems with LASIK and provide other information to help consumers make a decision about whether the procedure is right for them.