Washington, Nov 24 A significant percentage of people who undergo LASIK eye surgery to correct their vision may experience side effects from the surgery, a new study has claimed.
Malvina Eydelman of the US Food and Drug Administration and colleagues examined the frequency of patient-reported visual symptoms, dry eye symptoms, satisfaction with vision, and satisfaction with laser insitu keratomileusis (LASIK) surgery in the Patient-Reported Outcomes With LASIK (PROWL) studies.
The PROWL-1 study was a single-military center study of 262 active-duty Navy personnel (average age 29 years).
The PROWL-2 study was a study of 312 civilians (average age 32 years) conducted at five private practice and academic centres.
The LASIK surgery and the postoperative care were performed based on the usual practice and clinical judgement at the site. Participants completed a self-administered, web-based questionnaire, preoperatively and postoperatively at one and three months (the PROWL-1 and -2 studies) and at six months (the PROWL-2 study).
Results of the questionnaire indicated that visual symptoms and dissatisfaction with vision were common preoperatively.
Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms (double images, glare, halos and/or starbursts) after surgery (43 per cent from the PROWL-1 study and 46 per cent from the PROWL-2 study at three months).
The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores (an assessment of symptoms related to dry eye disease and their effect on vision) were 55 per cent at baseline, 66 per cent at three months, and 73 per cent at six months.
The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44 per cent at baseline and 65 per cent at three months.
Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28 per cent had mild, moderate, or severe dry eye symptoms at three months.
While most participants were satisfied, the rates of dissatisfaction with vision ranged from one to four per cent, and the rates of dissatisfaction with surgery ranged from one to two per cent.
"Our study is one of the few that have reported the development of new visual symptoms. While the overall prevalence of visual symptoms decreased, a large percentage of participants with no symptoms preoperatively reported new visual symptoms postoperatively," the researchers said.
The study was published in the journal JAMA Ophthalmology.