Study: Almost Half of LASIK Patients Experience Complications

The results of a new study from the FDA are likely to alarm patients who have considered undergoing LASIK surgery to correct refractive errors and improve their vision. The results indicate that nearly half of all LASIK patients experience eye surgery complications.

The study was launched on the heels of concerns expressed by patient safety advocates that the benefits of LASIK were being overstated while the risks may have been understated.

Collaborative study

The LASIK Quality of Life Collaborative Project (LQOLCP) study was launched in October 2009 as a joint effort. The FDA collaborated with the National Eye Institute (NEI) and the Department of Defense (DoD) to conduct the extensive study. The FDA noted that in 2009 when the initiative was launched, there was very little clinical data available with regard to patient-reported outcomes from LASIK.

The study went through several phases to explore LASIK eye surgery complications, with the first phase being a pilot study involving the comparison of patient-reported outcomes with paper questionnaires, a project in which 118 patients participated. For the second phase, the FDA used a web-based instrument to evaluate patient-reported outcomes, along with conducting interviews with prospective LASIK patients. Later, the FDA evaluated the difficulty level that LASIK patients experienced when completing everyday activities due to eye surgery complications.

LASIK eye surgery study results

After going through several more phases, the researchers concluded that up to 45 percent of all LASIK patients who participated in the study experienced at least one complication at a three-month interval after the surgery. These patients did not experience eye complications prior to the surgery.

Some of the LASIK eye surgery complications that were reported included dry eyes and visual symptoms such as halos, glare, starbursts, and double vision. Some patients have had difficulty with nighttime driving or driving with the glare of the sun. The most frequently reported symptom among participants in this study was the development of halos around light sources. As many as 35 percent of the participants developed halos at the three-month mark after surgery, despite not having had halos prior to surgery. Likewise, up to 30 percent of participants developed dry eyes, despite not having them before LASIK.

The patients who were least satisfied with the LASIK procedure reported all of the visual symptoms indicated on the questionnaire, such as halos and double vision. However, less than one percent of the patients surveyed indicated that they could no longer carry out their daily activities or that they had significant difficulty with daily activities after the surgery. The FDA has indicated that it will rely heavily on the findings from this study when updating its patient guidance information for LASIK procedures.

LASIK complication lawsuits

Some patients who have suffered from LASIK eye surgery complications have already filed lawsuits against their eye surgeons. Many of these lawsuits allege that their eye surgeons failed to properly screen patients to determine who would be a good candidate for the procedure. They further demand that the eye surgeons should be held liable for medical malpractice, as they allegedly breached the widely accepted standard of medical care when performing LASIK procedures.