FDA Proposes That Lasik Patients Must Be Warned About Complications - medtigo



FDA Proposes That Lasik Patients Must Be Warned About Complications

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Patients choosing Lasik to improve their vision should be advised that they may be left with double vision, dry eyes, trouble driving at night, and, in rare situations, persistent eye pain, according to a draft of FDA recommendations.

The text warns that people who have Lasik or laser eye surgery may still require spectacles. As per WION, since the draft of the guidance was made public in July, more than 600 individuals and professional groups have provided feedback. The agency is currently reviewing the feedback while drafting the final documents for deployment on a larger scale.  

The use of Lasik or laser eye surgery to correct poor vision is universally regarded as safe and common. According to data provided by the London-based Focus Clinics, thirty million people worldwide have successfully undergone laser eye surgery.  

Even after mending, the cornea will never be as robust as it was before surgery, according to the draft. Some patients informed the agency that they experienced life-altering problems, including eyesight loss, while the vast majority (almost 90 percent) expressed pleasure with their outcomes.  

The professional organization that represents optometrists, who conduct vision exams and prescribe eyeglasses and contact lenses, applauded the proposal and suggested adding additional safeguards regarding Lasik surgery for pregnant patients.  

The draft paper is supported by the 2017 findings of a study on the outcomes for Lasik patients. Together, the US FDA, the National Eye Institute, and the Department of Defense conducted the study. It evaluated visual complaints prior to and following Lasik. According to the draft document, the FDA also conducted its own meta-analysis of peer-reviewed research published between 2013 and 2018. 

Three months following Lasik surgery, over half of patients who had no visual complaints prior to the treatment developed a new visual aberration, most commonly halos, which are starburst-like formations surrounding lights. Nearly one-third of patients experienced dry eyes at three months.  

“Patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery prior to undergoing this elective procedure,” wrote the study’s authors. However, greater than ninety percent of patients expressed satisfaction with the outcome.  

In its own analysis, the agency determined that six months after surgery, 27% of patients experienced dry eyes, and 2% had difficulties that prevented them from engaging in normal daily activities.  

According to the FDA, five years after surgery, 17% of patients still required eye drops, 2% continued to experience visual disturbances, and 8% still had difficulty driving at night. 


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