FDA meeting with patients advocating LASIK ban

Those of you who have dry eye from LASIK may be interested to learn about a patient group meeting with representatives from the FDA on Thursday, September 13.

NEWS RELEASE - Sept 7, 2018 FDA Meets with Patients Advocating LASIK Ban

Mark your calendar for a news conference with a group advocating a ban on LASIK eye surgery. The news conference will take place on September 13, 2018 from 1:00 to 2:00 PM, in the Maple Room at the Sheraton Hotel, 8777 Georgia Ave., Silver Spring, Md. Prior to the news conference, the group will meet with FDA officials at the FDA’s White Oak facility in Silver Spring, Md….

“This is the first time the FDA has agreed to meet with us,” said Paula Cofer of Tampa, Fla., who founded the 6,100-member LASIK Complications Facebook Group in 2014 to give voice to people who have been harmed, she said, by corneal refractive surgeries. “Our membership grows daily because doctors convince patients these are safe surgeries. In fact, they can cause intractable, severe pain; corneal ectasia [deformity], chronic dry eyes, night vision problems and vision loss.”

In a recent blog post, I highlighted some information from TFOS DEWS II’s Pain and Sensation report about how LASIK eye pain patients have been instrumental in drawing attention to the problem of pain in ophthalmology, where traditionally it had been largely ignored. I imagine that the allusion in their report was simply to the collective impact of individual patients’ interactions with their individual doctors.

But for nearly twenty years there has also been a small but determined band of patients advocating for change at a regulatory level. And it seems they are finally getting their day to meet with the FDA.

All things considered, it is astonishing that it could take this long just to even start a dialogue. Consider:

• Peer-reviewed medical literature readily support concerns over the very high rates of dry eye as an extremely common as well as potentially permanent side effect of LASIK. Example here.

• According to this patient group, about 14,000 complaints have been filed with the FDA’s online Medwatch database. This is of course grossly understated, as most people have no idea that complications and side effects ought to be reported, and I wouldn’t hesitate to assert that most ophthalmologists would never consider reporting dry eye as a complication. I don’t believe the question of how many complications and adverse effects get reported has ever been studied.

• FDA involvement over the years in addressing concerns about the need to highlight risks when advertising/promoting LASIK has been scant at best. After gaps of many years. they might issue a little letter to the AAO like this one in which they “recommend” that advertising and promotional materials include information about risks.

The platform being advocated by the group is emotionally worded and extreme in nature:

[Aside: Based on a comment on this article, perhaps clarification is in order: (1) By describing the platform as ‘emotionally worded’, I meant specifically inclusion of phrases like “quit deceiving” and “lives are destroyed”; in no way do I intend to minimize the realities of patient outcomes; and (2) By describing the platform as “extreme in nature”, this is not a personal opinion of the appropriate regulatory steps to be taken in the circumstances but a reflection on how the platform being presented would be viewed by the industry, medical profession and FDA.]

1. Within 30 days, the FDA and doctors must quit deceiving potential patients with promises of zero side effects and, instead, warn the public about the true severity and prevalence of side effects, which is about 20 percent.

2. Within six months, the FDA must convene a panel on care and compensation of LASIK-injured patients, many of whom have lost their jobs and can no longer pay their medical bills.

3. Within six months, the FDA must ban these surgeries, before any more lives are destroyed.

And the bottom line they want to communicate is that “LASIK is inherently harmful….”

My personal perspective?

I could, and perhaps one day will, write a book about what’s wrong with the LASIK industry and about why, given the nature and extent of some of the harm that has been caused, it has not proven practical to hold the industry to account.

But to boil it down to a very compact summary in the meantime, my personal views are roughly as follows:

1. Due to a complex combination of factors, certain LASIK complications and side effects often cause us patients profound emotional harm, which in turn impair our perspectives in some degree at every stage of our journey - in crisis, in recovery, in stability and in advocacy. [Clarification: Since I have clearly offended some people with this, I will add that (1) as I have stated, this is my personal view; and it is based on observations from many years working with patients harmed by a wide variety of elective as well as medically necessary surgeries, which has given opportunities to compare; and (2) I could have been much clearer if I’d added “can in some degree” before “impair”. In suggesting that we incur emotional harm, I absolutely do not minimize or mischaracterize the reality of the complications and side effects but rather intend to add emphasis to how far reaching the nature of the harm done us is.]

2. Ample clinical data exist which would support a reasoned approach to the FDA and/or the AAO highlighting patients’ concerns about the reality of preventable and potentially untreatable harm being done to a minority of patients, that merits attention, and ought to be taken seriously if presented dispassionately and restricted solely to scientific evidence.

3. The American LASIK industry has consistently displayed a gross and determined lack of compassion for those of us who have suffered complications and side effects. Their sole objective when concerns are raised - whether through the press or through regulatory channels - has been to aggressively fight back with claims about subjective patient satisfaction rates (which no one disputes) as opposed to scientific data about ocular surface health outcomes and vision quality outcomes. No concessions, no conciliatory words, no compassion, and no resources are ever extended by industry representatives to those who have been harmed.

The whole thing really is a crying shame.

New York Times article on LASIK problems

A recent New York Times article which spotlighted persistent problems some patients experience after LASIK dredged up a lot of memories and emotions for me. 

I underwent LASIK on July 20, 2001. While the surgery was, technically, uncomplicated and picture-perfect (I even had a video in evidence), I experienced significant permanent vision complications as well as corneal nerve pain and dry eye. At the time these things happened to me, there was, and would continue to be for some years, insufficient medical knowledge and inadequate technology to even begin to understand or assess what was wrong, let alone repair it. The wavefront aberrometers that would later measure irregularities in the cornea that could scientifically explain the visual distortions I was subject to were not available then. Yet even in ensuing years with improved technology, doctors have routinely failed to use available technology to diagnose patients experiencing visual symptoms like mine. The improved understanding of dry eye disease, and the emerging understanding of neuropathic corneal pain, might be serving the patients of certain top tier specialists, but are not in evidence at LASIK surgical centers and therefore have rarely been immediately accessible to LASIK patients unless and until they chose to move on to other doctors for assessment and treatment.

This is just skimming the surface of the issues with the US LASIK industry's complacency and culpability for their unconscionable failures to serve the patients who experience complications and adverse effects. 

Blurred Vision, Burning Eyes: This Is a Lasik Success? (June 11, 2018)

....The Food and Drug Administration approved the first lasers to correct vision in the 1990s. Roughly 9.5 million Americans have had laser eye surgery, lured by the promise of a quick fix ridding them of nettlesome glasses and contact lenses.

9.5 million people for whom we have never had quality epidemiological data about their long term ocular surface results, either in clinical or symptom terms. The industry is far too well served repeatedly re-iterating its "satisfactions rates" and always eluding any meaningful conversation about the speciousness of satisfaction rates in the context of scientifically meaningful data, again, on either clinical or symptomatic results.

There is also a wide perception among patients, fostered by many eye doctors who do the surgery, that the procedure is virtually foolproof.

Yes. That perception is the crowning achievement of ~25 years of LASIK. The commoditization of an elective surgery to an incredibly delicate part of the eye has been so effective and thorough that the form you have to sign before you do it is a quarter the length of the form you sign to open a bank account.

As far back as 2008, however, patients who had received Lasik and their families testified at an F.D.A. meeting about impaired vision and chronic pain that led to job loss and disability, social isolation, depression — and even suicides.

Ten years ago, I testified at that very FDA hearing. So did many patients. And many attendees on the other side of the 'fence'.

Tuesday night when I read this New York Times article, I grimaced, I skimmed, I raged, I tweeted, I read, I deleted. Then I wandered down memory lane, did a little googling and ended up watching the video of my testimony, after all these years.

Have you ever listened to your own self talking, ten years ago? It's surreal.

To me, it was a painful listen. It took me straight back to the day of the hearing. The extreme polarization of the groups assembled ought to have been striking to anyone who wasn't on one side or the other.

On the one hand, patients and advocates, passionately, vehemently, urgently pouring out our pent-up concerns not just on our own behalves but for all those who could not be there. Patients with lives disrupted for years, not simply by poorly understood eye ailments but by the unexpected and crushing complication of their physicians' refusal to acknowledge what they were experiencing or assist them to find any sort of redress. And vulnerable patients whose lives were lost to suicide.

On the other hand, physicians, including an unexplained but powerful DOD contingent, dispassionately, cynically and effectively defending and marketing their trade at an event that was supposed to have been arranged in order to allow the public to voice its concerns. These physicians were palpably present as "industry representatives", period, as opposed to being present as doctors. It was clear from the outset there was no intention whatsoever on their side to be conciliatory. They were there to defend the inherent righteousness of their industry, without any concessions.

What I saw on these doctors' faces as I and others spoke, what I heard from their mouths when they spoke - these things weren't surprising, after almost seven years of conversing and emailing daily with patients who had experienced these things personally. But you can be shocked without being surprised, and I was shocked. Utter disregard for human suffering is always shocking, especially when coming from a profession that purports to exist for healing. Instead, they harmed: and the emotional harm inflicted by this profession, in my opinion, far outstrips any physical harm ever caused.

Even now, serious questions remain about both the short- and long-term risks and the complications of this increasingly common procedure....

It is unquestionable that a majority of LASIK patients (1) are satisfied and (2) have good results. But the fact remains that the success of the majority of patients in these 25 years has come at great cost to the minority of patients who experience problems, Their suffering has been tragically compounded by the failure of this industry - and I stand firm in calling it an industry, not a profession to care - medically, and as humans - properly for those who have been harmed. 

Study: Plasma Rich in Growth Factors for the Treatment of Dry Eye after LASIK Surgery

Plasma Rich in Growth Factors for the Treatment of Dry Eye after LASIK Surgery.

Ophthalmic Res. 2018 Jun 8:1-7. doi: 10.1159/000487951.
Sanchez-Avila RM, Merayo-Lloves J, Fernandez ML, Rodriguez-Gutierrez LA, Jurado N, Muruzabal F, Orive G, Anitua E.

Abstract:

PURPOSE:

The aim of this study was to evaluate the use of plasma rich in growth factors (PRGF) eye drops in patients with dry eye disease after laser-assisted in situ keratomileusis (LASIK) surgery.

MATERIAL AND METHODS:

This is a longitudinal, retrospective, comparative, and descriptive study of 77 eyes of 42 patients with dry eye disease following LASIK surgery. This study was designed to evaluate the efficacy of PRGF treatment compared to conventional therapy (control group). Outcome measures including signs and symptoms of dry eye disease were evaluated before and after treatment. The percentage of change before and after treatment for each clinical variable measured was compared between both groups.

RESULTS:

There were 1-4 treatment cycles with PRGF eye drops (1 cycle = 6 weeks). Results showed a statistically significant improvement in the Ocular Surface Disease Index (38.12%), visual analogue scale scores for frequency (41.89%) and severity (42.47%), and the Schirmer test scores (88.98%) after PRGF treatment (p < 0.05). No adverse events were reported after PRGF treatment.

CONCLUSIONS:

These results suggest that PRGF eye drops are effective for the improvement of dry eye symptoms in patients who underwent LASIK surgery in comparison to the conventional therapy. The treatment with PRGF is an alternative for patients who suffer from postoperative dry eye.

Abstracts: Plugs after LASIK

... Nothing particularly groundbreaking here... and I'd like to know how they measured symptoms.

Punctal plugs for treatment of post-LASIK dry eye.

PURPOSE:
To evaluate the efficacy of punctal plugs for patients with post-LASIK dry eye
.
MATERIALS AND METHODS:
A prospective study was conducted on 25 eyes of 18 patients who underwent LASIK. All eyes fulfilled the Japanese dry-eye criteria and had not responded to conventional treatment with artificial tears by 1 month postsurgery. They were randomly divided into a plug and a non-plug group. Punctal plugs were inserted into the superior and inferior puncta in the plug group after the 1-month examination. Uncorrected and best corrected visual acuity (UCVA, BCVA), refraction, functional visual acuity (FVA) after 10 s eye opening (FVA 10), surface regularity index (SRI) after 10 s eye opening (SRI 10), corneal sensitivity, Schirmer test, fluorescein staining (FS), tear break-up time (TBUT), and symptoms were compared between the groups 1 and 3 months postsurgery. Changes in these data from 1 to 3 months were also compared between the groups.

RESULTS:
The values in SRI 10, FS, and TBUT were significantly better in the plug group at 3 months. Changes in the values of UCVA, FVA 10, FS, TBUT, and symptoms between 1 and 3 months improved significantly in the plug group compared with the non-plug group.

CONCLUSION:
Our results suggest that punctal occlusion for both puncta is effective for patients with post-LASIK dry eye that cannot be controlled by artificial tears alone. Punctal plugs can improve not only the symptoms and tear function, but also the quality of vision, for example FVA.

Jpn J Ophthalmol. 2012 Feb 23. [Epub ahead of print]
Yung YH, Toda I, Sakai C, Yoshida A, Tsubota K.
Source
Smile Eye Clinic, Yokohama, Japan.

Abstract: Simultaneous LASIK and corneal inlay implants

No matter what the scientifically accepted follow-up percentage standards for this sort of cohort study, I am always suspicious of any 6-month complications data that reports results for fewer than half of the patients that underwent ANY elective refractive surgery. Why? Because I know how many people ditch their doctor in favor of someone else when they have post-operative complaints after such a surgery (in contrast to medically necessary eye surgery). 64 out of 180. Really? That the best you could do?

With that in mind you'll understand why I feel I think the word "occasionally" (my highlight below) should be read with sincere skepticism.

Simultaneous corneal inlay implantation and laser in situ keratomileusis for presbyopia in patients with hyperopia, myopia, or emmetropia: Six-month results.

PURPOSE:
To evaluate the safety and efficacy of simultaneous Kamra corneal inlay implantation and laser in situ keratomileusis (LASIK) for the treatment of presbyopia in emmetropic, hyperopic, or myopic patients.

SETTING:
Private center, Tokyo, Japan.

DESIGN:
Cohort study.

METHODS:
Patients had bilateral LASIK with simultaneous implantation of a corneal inlay in the nondominant eye to treat presbyopia and ametropia between September 2009 and April 2010. The efficacy and safety were determined by the spherical equivalent (SE) in the eye with the inlay.

RESULTS:
The study enrolled 360 eyes of 180 patients with a mean age of 52.4 years ± 5.1 (SD) (range 41 to 65 years). Sixty-four patients were available for the 6-month postoperative examination. The mean logMAR uncorrected near visual acuity in the eye with the inlay improved 7 lines in hyperopic eyes, 6 lines in emmetropic eyes, and 2 lines in myopic eyes. The mean logMAR uncorrected distance visual acuity improved by 3 lines, 1 line, and 10 lines, respectively.

CONCLUSIONS:
Simultaneous intracorneal inlay implantation and LASIK to treat presbyopia with emmetropia, hyperopia, or myopia was clinically safe and effective, yielding improvement in distance and near visual acuity. Patients were satisfied with decreased dependence on reading glasses regardless of the preoperative SE range. However, postoperative symptoms, such as dry eyes, halo, glare, or night-vision disturbances, occurred occasionally.

FINANCIAL DISCLOSURE:
Dr. Waring has a financial interest in and is world surgical monitor for Acufocus. No other author has a financial or proprietary interest in any material or method mentioned.

J Cataract Refract Surg. 2012 Mar;38(3):495-506.
Tomita M, Kanamori T, Waring GO 4th, Yukawa S, Yamamoto T, Sekiya K, Tsuru T.
Source
From the Shinagawa LASIK Center (Tomita, Kanamori, Yukawa, Yamamoto, Sekiya, Tsuru), Tokyo, Japan; ReVision Advanced Laser Eye Center (Waring), Columbus, Ohio, and St. Joseph's Translational Research Center (Waring), Atlanta, Georgia, USA.