Friday, April 11, 2008

Study: LASIK dry eye

Truth be told... I've always had a little bit of a grudge against this journal because although it is dedicated exclusively to refractive surgery, it rarely talks about dry eye - which just happens to be the #1 side effect of laser refractive surgery.

But today, hats off and grudges begone. Wow! Thank you for acknowledging what so badly needs to be said.

Now if we could just get this included in every LASIK informed consent form.

My only reservation/criticism about this abstract is that some use this kind of thing to justify what amounts to temporarily suppressing a chronic ocular surface problem in order to justify LASIK on a high risk candidate. Even that might not be as much of a problem as it is were it not that ocular surface diseases are so frequently misdiagnosed and undertreated (see my article on diagnosis.

LASIK-associated Dry Eye and Neurotrophic Epitheliopathy: Pathophysiology and Strategies for Prevention and Treatment
Renato Ambrósio Jr, MD, PhD; Timo Tervo, MD; Steven E. Wilson, MD
Journal of Refractive Surgery Vol. 24 No. 4 April 2008

To review the pathophysiology of LASIK-associated dry eye conditions and provide insights into prophylaxis to decrease the incidence of dry eye after LASIK and to treat the condition when it occurs.

A review of the literature was performed on LASIK-associated dry eye and the experience of the authors was summarized.

LASIK has a neurotrophic effect on the cornea, along with other changes in corneal shape, that affect tear dynamics causing ocular surface desiccation. Dry eye is one of the most common complications of LASIK surgery. Symptoms of dryness may occur in more than 50% of patients, with other complications such as fluctuating vision, decreased best spectacle-corrected visiual acuity, and severe discomfort occurring in approximately 10% of patients. Preoperative dry eye condition is a major risk factor for more severe dry eye after surgery and should be identified prior to surgery. Optimization with artificial tears, nutrition supplementation, punctal occlusion, and topical cyclosporine A in patients with symptoms or signs of dry eye prior to LASIK decreases the incidence of more bothersome symptoms following surgery. Patients with LASIK-induced neurotrophic epitheliopathy often respond to topical cyclosporine A treatment, which treats the underlying inflammation and may benefit nerve regeneration.

LASIK-induced dry eye and neurotrophic epitheliopathy are common complications of LASIK surgery. Optimization of the ocular surface prior to surgery decreases the incidence and severity of postoperative symptoms of the condition.

Wednesday, April 9, 2008

Drug news: Cationorm - OTC drop from Novagali released in France

According to an April 9 press release, Cationorm has been released in France as an unpreserved over-the-counter drug and is expected to be released as an OTC in the US by the end of 2008. It is described as:

a cationic emulsion with no active principle, for the relief of mild dry eye syndrome

utilizing Novagali's "Novasorb" technology which is "based on the electrostatic attraction that occurs between the droplets of a positively-charged emulsion and the negatively charged cells of the ocular surface, including cornea and conjunctiva."

Last time I heard any news of this one was from ARVO last year where it was reportedly "well tolerated" and showed "upward trending" in clinical signs. My notes to myself at the time included "But did it outperform placebo?" Well, if any of you try it and like it, let me know.

Monday, April 7, 2008

Rebecca's Omega 3 journal: Echoing Dr. Macsai on supplements...

With all the cornea docs congregating in Chicago the past few days for the annual ASCRS conference, I feel a bit like a dog waiting patiently under the table to be thrown a bone. The overwhelming focus of the meeting is, of course, as the name states (cataract and refractive surgery) but with enough cornea brains in one place there are bound to be one or two pearls about dry eye emerging somewhere. We can always hope, anyway.

So the last email update I got had OSN Supersite quoting Dr. Marion Macsai (some of you know her... prominent cornea/lasik doc practicing north of Chicago) about supplements:

More research needed on the most effective nutritional supplementation for dry eye

CHICAGO — The use of nutritional supplements, including flax seed oil, fish oils and vitamin E, to combat the effects of dry eye appears to have positive effects on the disease, but an objective study is needed to know for sure, according to a speaker here.

"There's probably a role for dietary supplementation, Marian S. Macsai, MD, said here at Cornea Day held before the American Society of Cataract and Refractive Surgery meeting. "Clearly they work, but objective data is needed to validate the dose, the effects and the exact combination."

Dr. Macsai said current published literature evaluates the diaries of patients to establish a correlation between the patients' diets and changes in their dry eye symptoms.

Dr. Macsai said patients with Sjögren's syndrome have been shown to have lower vitamin E levels, so there might be a need for supplementation, she said.

"The question is: 'Which vitamin E,'" she said. "There's a tendency to think they are all the same."

Dr. Macsai said clinicians should make sure to tell patients to buy flax seed oil pills that are sold in opaque bottles so the oil does not lose its potency. Those pills seem most effective, she said.

"Ground flax seed is a great source of fiber, but it's not going to help your dry eye," Dr. Macsai said.

As regards objective studies, you bet! Any takers...???

Industry news: Upcoming FDA hearing on quality of life after LASIK

I've been following this for some time but did not comment earlier because I was not sure what to make of it. I'm still not, but the most recent press report irked me enough that I need to make a start on it. Since dry eye is well documented as the #1 complaint following LASIK, any serious post-market surveillance the FDA is doing needs to be taking a good look at dry eye.

Last month, there was an announcement that ASCRS, AAO and the FDA were forming a joint task force "charged with formulating a viable study design to identify dissatisfied post-LASIK patients, define their significant symptoms and evaluate the influence of those symptoms on quality of life, according to a joint press release from ASCRS and AAO."

OSN Supersite's March 17 article explains the origins of this meeting as follows:

Encouraged by FDA petitions urging for an effective freeze on nonessential eye surgeries, the FDA initially approached ASCRS in fall 2006 for assistance in designing the post-LASIK quality-of-life trial. Although the FDA did not deem the majority of requests worthy of new investigation, the agency has permitted the petitioners to present testimony at a special meeting of the Ophthalmic Devices Panel scheduled for April.

...suggesting that unhappy LASIK patients have been successful in getting some amount of attention from the FDA.

More recently, the FDA confirmed the date for the next ODP meeting as April 25th. This is open to public participation.

Today, ASCRS in this release...

ASCRS To Participate In and Co-Fund Study on Post-LASIK Quality of Life with U.S. Food and Drug Administration

...elaborated, a little anyway, on how it is teaming up with the FDA, NEI and AAO for the study.

Now down to the part that is really irking me. Read this:

Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients. In 2006, the FDA re-evaluated symptoms and satisfaction data and reaffirmed that while the vast majority of LASIK patients were indeed satisfied with their outcomes, a few were not.

While I'm not going to dispute that a large majority of LASIK patients are satisfied, this quote bothers me terribly. It appears to be trying to convey that the dissatisfaction rate is as low as 1 in 10,000 and I think this is a disingenuous use of the statistics, i.e. the 140 "comments" received by the FDA.

First of all, a rate of 1 in 10,000 (0.01%) is flatly contradicted by pretty much every study of patient satisfaction I've ever seen.

Second, most consumers who are dissatisfied after a surgery are not going to file a complaint with the FDA. Why? Because we (consumers) associate surgeries with doctors, not devices, and the FDA regulates only the latter not the former. Of the people who are dissatisfied with their outcome, the minority who go so far as to try to file some kind of complaint are far more likely to contact the bodies overseeing the doctors, i.e. state medical boards. Complaints to state medical boards are, in general, kept confidential, except in those very exceptional cases where the complaint actually results in disciplinary action.

Third, what are these 140 "comments" received by the FDA about patient dissatisfaction? What reporting system did they go into? I don't suppose it occurred to anyone to check the MAUDE database. Surely, at least some of the device malfunctions serious enough to be reported as an MDR must have resulted in dissatisfied patients? In the time period covered by those 140 comments (1998-2006), there were 339 MDRs filed on the LADARvision excimer laser alone. Another 156 on the Intralase femtosecond flap-making laser. To say nothing of the various mechanical microkeratomes.

Like I said, I'm not arguing that everyone's unhappy after LASIK. But LASIK dry eye IS a widespread problem; patients know it; doctors know it; and our Dry Eye Talk community bulletin boards provide ample daily evidence of the dramatic impact on "quality of life" for those unfortunate enough to experience it.

Business news: Novartis to acquire stake in Alcon

Novartis is acquiring a minority stake in Nestle-owned Alcon and an option to acquire a majority stake, which would make it the 2nd-largest

Novartis to buy Alcon stake for $39 billion

Novartis AG (NOVN.VX) has agreed to buy Nestle AG's (NESN.VX) 77 percent stake in U.S. company Alcon (ACL.N) in a deal worth up to $39 billion to boost its eye care business, the Swiss drugmaker said on Monday.

Novartis will acquire a first, 25 percent stake in Alcon for $11 billion and is set to buy Nestle's remaining 52 percent for a fixed price of $28 billion between January 2010 and July 2011.