FDA releases LASIK patient survey, warns of large numbers of dissatisfied patients

Despite patient satisfaction with LASIK outcomes exceeding 94 per cent in most categories, the procedure  still presents significant risk, according to a preliminary analysis by the US Food and Drug Administration of two studies using a comprehensive new satisfaction assessment tool.

“Given the large numbers of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may occur in a significant number of patients,” Malvina B Eydelman MD, director of the FDA’s division of ophthalmic devices, told the Refractive Surgery Subspecialty at the 2014 AAO annual meeting.

Three months after surgery, about 45 per cent of LASIK patients without preoperative visual symptoms reported developing at least one new visual symptom, Dr Eydelman noted. These include haloes at up to 35 per cent, followed by starbursts at up to 28 per cent, glare up to 16 per cent, and ghosting up to 6 per cent. These visual symptoms were “very” or “extremely” bothersome in up to 4 per cent of patients when not wearing correction, and were severe enough in 1 per cent to cause a lot of difficulty or make it impossible to perform usual activities without wearing correction.

Visual symptoms were reported much more often in patients dissatisfied with their post-LASIK vision than those satisfied with vision. For example, up to 70 per cent of dissatisfied patients reported glare and up to 100 per cent haloes, compared with 25 per cent and 36 per cent respectively among satisfied patients. This suggests visual symptoms are a cause of LASIK dissatisfaction, though the statistical analyses that may support this have not yet concluded, Dr Eydleman said.

However, the overall prevalence of very or extremely bothersome visual symptoms was much higher preoperatively than after LASIK. For example, up to 10.8 per cent reported very bothersome haloes before surgery compared with 0.8 per cent after LASIK, while 2.8 per cent said these haloes interfered with usual activities before surgery compared with 0.4 per cent or less after LASIK.

Visual acuity results were also excellent, with more than 95 per cent achieving 20/20 uncorrected binocularly, and 90 per cent 20/20 uncorrected monocularly at three months. Only one patient of 484 lost two lines of visual acuity, with none worse than 20/40 corrected, and none worse than 20/25 corrected who had 20/20 or better corrected before surgery.

The studies were conducted using a comprehensive online questionnaire developed for the LASIK Quality of Life Collaboration Project by the US National Eye Institute with support from contract researchers EMMES and RAND. The FDA, US military and private sector ophthalmologists participated.

The LQOLCP questionnaire examines multiple dimensions of patient experience before and after surgery. These include vision quality, symptoms of aberrations, work productivity, dry eye symptoms, mood symptoms, expectations before surgery, satisfaction after surgery and impact on social desirability. Questions include illustrations of visual disturbances such as glare and starbursts. Patients are surveyed at baseline, on the day of surgery and one, three and six months after surgery.

Question concepts were drawn from media, literature and patient reports. Questions were developed from existing surveys where applicable and developed independently as required. All questions and the survey online instrument were psychometrically validated and tested for usability, and revised.

Results presented were from PROWL-1, using an initial version of the validated survey conducted in government facilities completed by 224 patients through three months follow up, and PROWL-2, using a slightly revised questionaire in private clinics completed by 260 patients. Additional analyses of results are underway and will be published, Dr Eydelman said.