Let's be positive and apply the old saw about the dual interpretation of the Chinese word for threat/opportunity: The news that the FDA has decided to re-examine the safety of LASIK is an opportunity.

The agency has been toying with this idea for a couple of years and has decided to hold a public Ophthalmic Devices Panel meeting in late April to consider the task of conducting a study that identifies dissatisfied LASIK and phakic IOL patients and measures quality-of-life outcomes in these patients. Why? That part's problematic.

So far, the agency is citing "a few" unhappy post-LASIK patients' complaints as the impetus. They must be really big, really loud or really unhappy patients to induce a grossly overworked and underfunded agency that clearly has better things to do than reexamine a surgical procedure that has been safely performed for almost a decade and a half. The agency could just review Jorge Alio's 10-year follow-up on LASIK and PRK published in January and February in AJO and the British Journal of Ophthalmology and save a lot of people another night in the Gaithersburg Hilton. But we're being positive here.

Fortunately, they've enlisted the help of the AAO and ASCRS in approaching this issue, so we can be confident that the refractive surgeon's perspective will be well-represented. Actually, the agency has no funding for such a study and no access to patients without the involvement of these groups, but we're being positive here.

So we can be confident that the instrument that is used to assess quality-of-life issues in post-LASIK patients will be one that is validated for use in such a population. No such instrument exists right now but that's the opportunity. We can be confident that the study will deal with the problems inherent in a self-selected patient population's entirely subjective assessment of their condition.

We can be confident that the study will be constructed so that results can document quality-of-life outcomes by such variables as the dissatisfied patient's specific preop refractive error, emotional and psychological state, commercial laser center versus private practice, type of procedure, custom treatment versus non-custom, surgeon volume and other issues that make a real contribution to the refractive surgeon and patient. This could be the most useful study yet. I'm positive.