For many years I have shared with most people a sense of wonder and gratitude for the technology of Lasik surgery.   And absent much reaction to the millions of procedures done, it seemed very safe.  Everyone I know who has had it done loved the experience and its impact.  No one has mentioned any complications.

But in the Health section of the Times this week, a major article presents data from FDA studies, and many personal studies, that dramatically change how we now look at Lasik surgery.

Here is the article:

https://nyti.ms/2MgoGBT

The Times article presents information that convincingly argues that if you have Lasik surgery on your eyes, you are at risk for very painful and/or vision-altering complications that can last a very long time.

It should be said at the outset of this review that many people do indeed experience Lasik surgery and have only positive experiences.  They experience no pain, they experience no visual aberrations, they only experience the joy of normal vision.  That happens, and it happens a lot.  And for the millions of people who have a very positive experience, all is well, and the surgery was a great idea.

But we now know that this is not everyone’s experience.  This is important to note for anyone who has not yet had Lasik surgery and is thinking about having it done.

As with any procedure, the question always is, do the benefits outweigh the risks?  It only makes sense to know the risks if you are trying to answer this question about Lasik.

The LASIK procedure

The idea of LASIK surgery is to sculpt the cornea so that it focuses precisely on the retina, thereby eliminating errors of focus such as near-sightedness or far-sightedness.

LASIK is an acronym which stands for Laser-Assisted In-situ Keratomileusis.

The first two letters are self-explanatory, it is a type of surgery, or cutting, that uses a laser for part of the procedure.  In-situ means simply in place, meaning the cornea is sculpted in its normal position in the eye, it is not removed to change its shape.   Keratomileusis is a new word from the 1990’s that is a combination of two Greek words.  Kerato means cornea.  And smileusis means carving.  So  Keratomileusis means carving the cornea.

The procedure involves making a cut into the cornea that allows a computer to craft the shaving of just the right slices of cornea to change its shape so that it focuses normally on the retina.

When it works, there is no pain, vision is improved toward 20/20 in both eyes and the need for glasses and contacts may end entirely.

The Reports on Bad Outcomes

The Times article presents a number of published studies that document that there can be some very serious side effects to Lasik surgery.

The side effects of concern are in two types:

• Dry Eye and Eye Pain
• Vision Aberrations

Lasik surgery was initially approved for use by the FDA in the 1990’s, here are the studies since that time reported in the article:

1. 2007. A study done by Ohio State found that 20% of people who had Lasik surgery found their dry eye symptoms got worse.
2. 2008. At a hearing held at the FDA, former patients who underwent  Lasik surgery testified that they had experienced  impaired vision, chronic pain, job loss, disability, isolation, depression, suicide
3. 2016. A review paper was published stating no serious side effects were noted after Lasik surgery, but only followed patients for 6 months post surgery.
4.  2017. Lasik surgeon review of FDA reports that year of  roughly 350 patients:  trouble driving at night up to 20%, mild glare 20%, halos 20%, mild dryness 40%.
5. Very recently.  The FDA very recently concluded a clinical trial, and enrolled 574 participants. In those without prior symptoms, 28% developed dry eyes, and 45% had visual aberration at 3 months.   For all in the study, 50-60% had glare, halos, and double vision.  For a total of 5%, these side effects were very or extremely bothersome.  At 6 months post surgery the rate of visual aberrations was 41%, and for dry eyes 25%.
6. Not dated.   A large Lasik provider found that even after 5 years post surgery, 50% had dry eyes for part of that time, 40% were sensitive to light, 33% could not drive at night or do close detail work well.
7. Not dated.  A surgeon, Dr. Gabor, has reported in their review that dry eye symptoms occur after Lasik surgery in 20-50% of patients for 6 or more months after surgery.

The article also cites some personal accounts:

1. Morris Waxler was once the head of the diagnostic and surgical device branch of the division of ophthalmic devices of the FDA.  On surveying the emergence of these serious side effects, he has since regretted helping preside over the original FDA approval of Lasik surgery in the 1990’s.
2. Two men were cited who are said to have committed suicide because of the intensity of the pain occurring from dry eyes after the surgery.
3. Some patients have reported other outcomes following Lasik surgery, including: developing cataracts, corneal abnormalities like corneal ectasia, interference with screening tests that find glaucoma.
4. Some ophthalmic surgeons cited their understanding that Lasik surgery always involves cutting tiny corneal nerves, thins the cornea, weakens the cornea, and permanently changes the shape of the eye.  They go on to state that all people who have Lasik surgery lose some degree of contrast sensitivity, distinguishing shades of gray.

BOTTOM LINES

1. Lasik surgery is surgery.  As with nearly all drugs and all surgeries, there turn out to be impacts from this intervention that can be very harmful.  And, again, like so many drugs and so many surgeries, people can experience tremendous benefit with no bad impacts at all.
2. For many years, Lasik surgery has been thought to be very different from any other surgeries, free of all bad outcomes, but the article in the Times makes it clear this is not the case.
3. Published studies establish that anyone who is thinking about undergoing the cutting of the cornea that is Lasik surgery should know that two very major problems can and do happen after the procedure to something like 20-50% of the people who have it done:  dry eyes which can be very, very painful; and changes in vision, which can also be disabling.

It is very upsetting to read that a common surgery once felt to be free of harm, can cause harm, but hopefully helpful to know.

To your health,
Dr. Arthur Lavin