This is a guest post by life sciences entrepreneur Mikael Totterman
In my last post (When it comes to investing, the eye has it) I wrote that venture investors are flocking to ophthalmic investments due to extensive unmet needs. One such need is refractive correction. The vast majority of the 150 million Americans who require refractive correction still rely on old-fashioned glasses and contact lenses. Laser-Assisted in situ Keratomileusis surgery (LASIK) is a solution for some, but there are only 700,000 procedures in the US per year, just a tiny fraction of the potential.
It led me to ask, what’s going on with LASIK, and can LASIK be improved?
Is There an Opportunity to Improve LASIK?
One of the more interesting studies presented at the 2014 American Academy of Ophthalmology meeting #aao14 were the results from the LASIK Quality of Life Collaboration Project (LQOLCP). The study has been an extensive collaborative effort between the Food and Drug Administration, the National Institutes of Health, and the Department of Defense.
The key findings are:
- LASIK can very reliably correct vision
- Many patients who undergo LASIK experience unwanted side-effects and complications
My takeaway: Perhaps there is an opportunity to develop a next generation LASIK that is less invasive and has fewer side effects.
LASIK is Able to Very Reliably Correct Visual Acuity
In terms of 3-Month Visual Acuity Outcomes, over 95% of the subjects achieved 20/20 or better binocular uncorrected vision. For monocular uncorrected visual acuity, 90% of the patients achieved 20/20 or better. Not surprisingly, 96% of the subjects were satisfied with their visual acuity following the LASIK procedure.
LASIK Procedures are not Without Risk of Side Effects for Large a Number of Patients
In addition to assessing visual acuity, the objective of the study was to better understand what types of side effects LASIK patients experience. LASIK is a surgical procedure that typically involves cutting of a flap in the eye, so it is reasonable to expect that some types of side effects will arise.
Over 45% of subjects who were symptom-free prior to the procedure developed at least one new symptom at 3 months following the procedure. These new symptoms included ghosting (3%-6%), glare (15%-18%), halos (26%-35%), and starburst (26%-27%).
Additionally, 30% of subjects developed new dry eye symptoms as a result of the LASIK procedure.
FDA’s summary comment in terms of the Public Health Impact was:
“Given the large number of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may occur in a significant number of patients”
“FDA will explore avenues to better inform patients and physicians about LASIK risks.”
In other words, LASIK works great at improving vision but there are real downsides for many patients.
Could a Better LASIK be Developed?
If the industry could develop a less invasive LASIK procedure (i.e., no flap or ablation), maybe these side effects could be reduced or eliminated.
November 5, 2014