4/25/08 FDA LASIK Hearing: The open public hearing (2 of 2)

(Continued)

RICHARD LINDSTROM MD
LASIK surgeon. Immediate former ASCRS president. Dr. Lindstrom was unable to attend due to illness and a statement was read on his behalf by Kerry Solomon MD.

We find all available clinical data reinforces the safety and efficacy of LASIK....

(An aside: I think this quote effectively sums up the collective input by surgeons speaking either on their own behalf or on behalf of professional societies on Friday. I will save any further comment on what’s glaringly missing from that response for another post.)

His message to complications patients was:

We hear, we care, and we are responding. The satisfaction rate of LASIK is higher than that of any other elective surgery, but it can be improved. We’re here to understand the subjective reasons for dissatisfaction.

I noted down only one other items from Dr. Lindstrom’s statement:

The primary patient advocate is the patient’s physician.

ERIC DONNENFELD MD
LASIK surgeon

Like all the LASIK surgeons who spoke at the hearing, Dr. Donnenfeld is one of the top leaders in his field. (I believe he stated that he was attending as representative of ASCRS but I need to confirm this.)

Dr. Donnenfeld described at length his passion for improving quality of life in his LASIK patients and explained that he has peformed LASIK on 800 doctors and their families. He stated that LASIK has always been very safe. He compared the risk from contact lenses to the risk from LASIK.

Dr. Donnenfeld was the only one of the doctors presenting that directly addressed dry eye. I have been trying hard to refrain from commenting on the presentations while I’m describing them and here, and I’m about to make my first major exception. Between the outrageously misleading character of some of the statements and the eggregious abuse of medical literature in support of them... On second thought, this deserves its own blog post, so I reserve further comment.

Dr. Donnenfeld began by saying that an estimated 55 million Americans suffer from dry eye, including people who have had LASIK. He went on to describe how the recently formed LASIK task force undertook an extensive review of the medical literature. Charts, graphs etc. in abundance of all the peer reviewed articles. The results here presented were as follows:

- 32% of people experience pre-operative symptoms of dry eye
- 35% of LASIK patients experience post-operative dry eye.
- Severe dry eye post LASIK is “extremely rare”.

Dr. Donnenfeld talked about how there are many exciting therapies under FDA evaluation.

Dr. Donnenfeld’s bottom line message was that LASIK improves lives. He was cut off for time when he launched into a story about a transplant patient of his.

DOYLE STULTING MD
LASIK surgeon. Emory University. Editor-in-chief of Cornea (a peer-reviewed medical journal).
A statement was read on his behalf by Scott Barnes. Mr. Barnes was in military dress but I did not manage to hear his rank.

I took only very cursory notes of the statement by Dr. Stulting. I think this is where I was distracted by the person next to me, or perhaps I was even suffering from a little ennui. I’ll indulge just this once in simply reproducing my unabridged scribbles:

“Another AMO consultant. Focuses on those with less NVD after than before. Better technology, better screening etc. Blah blah. How much it helps the military.”

KERRY SOLOMON MD
LASIK surgeon. Storm Eye Institute.

Like Dr. Donnenfeld, Dr. Solomon focused on ASCRS’ recent medical literature review about patient satisfaction and quality of life. He talked about the 95% satisfaction rate being higher than all other elective surgeries.

ODP chair Dr. Weiss took the trouble of clarifying at the end of Dr. Solomon’s talk that ASCRS had conducted that literature review off their own bat, not at the request of the FDA.

TODD KROUNER
Attorney.

Mr. Krouner urged the FDA to be independent in the QOL study they are undertaking. He said that since the industry is convinced there is such a high satisfaction rate, they should welcome independent confirmation of that.

He talked about how complex the LASIK screening process can be.

He discussed the problem of industry under-reporting of post-market device problems and is concerned about mandatory reporting not being enforced.

He showed some nice visuals demonstrating the difference between vision quality and acuity and discussed what he termed the dishonesty of claiming LASIK success based on uncorrected acuity (i.e. what line you can read on the chart) alone. He used as an example the recent story of Abby Ellin in the New York Times.

PETER MCDONNELL MD
LASIK surgeon, Wilmer Eye (Johns Hopkins)

I had rather scanty notes on this talk.

Dr. McDonnell talked a bit about technological improvements.

He stated that many patients seek LASIK because of dry eye symptoms wearing contact lenses, and some get dry eye syndrome afterwards. Talked about how contact lenses have their own risks. (One of my notes to myself is the implication that LASIK may be safer.)

NAME?
This is the only one I did not catch at all. She is on the “joint task force”, represents ASCRS (I think?), has a background in psychiatry and psychosomatic medicine, and is or was a Navy physician.

Like others she talked about wanting to better understand the “small number of dissatisfied individuals” and their “subjective experiences”.

She discussed quality of life as being comprised of both physical and psychological factors.

She stated that 20 million people in the US suffer from depression and emphasized that depression is almost always multifactorial, extremely unlikely to be caused exclusively by a single event. She indicated many other key factors include background, personality, coping skills and genetics.

If I didn’t happen to know better from my many years of interacting with depressed LASIK patients, my take-home message (and it’s a relatively easy sell to an unsuspecting public) would have been that there is something already wrong with these people who get depression after LASIK.

STEVE SCHALLHORN MD
LASIK surgeon. Ex Navy. I will have to doublecheck when the transcript comes out but it was my impression he was present representing the AAO.

Another one for which I had scanty notes. He said something about quality of life results being a different matter than safety and efficacy and emphasized that sometimes there are simply other factors in patient satisfaction that we can’t explain.

He told a story about a firefighter and contact lenses and I got distracted somewhere during it.

DR. TERRI ETHBANKIS (sp?)
Psychologist? I did not catch the details – apologies.

Physician counselor for LASIK complications support groups for several years. Discussed depression and anxiety related to LASIK outcomes.

Also discussed some future eye health concerns for LASIK patients as they age, including more complicated cataract surgeries and possible future complications because of the flap interface.

She talked of LASIK problems as an open secret and described it as a disgrace of modern medicine.

KIM HARBINGER
Patient with complications. Statement was read on her behalf.

Kim was a nurse who had RK 14 years ago. Her prescription regressed and in 2006 she underwent LASIK by a surgeon who told her it was “no problem”. (For those who don’t know, LASIK over RK is anything but “no problem”. Cutting a flap in a cornea that has a whole bunch of incisions in it from RK is ticklish business to say the least.)

Her complications left her depressed and suicidal and this was described at some length. Hard contact lenses have now improved her vision.

Her bottom line: “Medical remedies trial medical advances.”

DR. MICHAEL MULLORY
Patient with complications.

Dr. Mullory pushed for mental health professionals to be the ones studying quality of life after LASIK. He discussed a publication in a medical journal about fear of vision loss and its relation to suicide risk which was really quite interesting and ties into something I’ll be posting about later on.

He asserted that depression screening for patients before surgery (which has been suggested by some in the industry) is not the answer, but that stopping vision loss is.

He told the story of “Ajay”, with severe depression despite no mental health history, and additional stories of patients with suicidal ideation, all involving patients whose doctors considered them “successes” based on their visual results. One such patient, who underwent a transplant, he said had their concerns compounded by a sense of collusion in a medical community where none of the local doctors consulted told her she had ectasia.

Dr. Mullory called for a moratorium on LASIK but suggested that if this was impracticeable then the device labelling should include depression and suicide as risks.

COURTENEY HENDRICKS
Patient with good outcome. Quadraplegic.

ASCRS paid for Courteney to attend the meeting. Her story was similar to Barry Elbasani’s – loss of independence, and a wonderful sense of regaining a small piece of independence by no longer being dependent on others for things like wiping smudges from her glasses.

AMANDA CAMPBELL
Widow of complications patient who committed suicide. Unable to attend; attorney Todd Krouner made presentation on her behalf.

Mrs. Campbell is the widow of Lawrence Campbell, who committed on March 16th, 2008. Mother of two children, she could not afford to come because of her situation.

She shared details of his suicide note. It included a detailed description of how unremitting pain from chronic dry eye limited his activities and affected him emotionally, and how he did not want to live out the remainder of his life on Xanax.

The note concluded with the statement “Do not have LASIK surgery. Tell the media.”

Mrs. Campbell said he had no mental illness history whatsoever and that LASIK was unquestionably the contributing if not the sole factor in his suicide.

She (or Mr. Krouner?) named the laser center where the surgery was performed, stated that they did not know whether malpractice occurred, but also stated that the widow and children had so far been denied access to Lawrence’s medicla records.

Mr. Krouner ended with a request that the FDA’s work be more transparent. He complained that he had filed a Freedom of Information Act request with the FDA with respect to Alcon related documents 9 months ago and had not received them. At that point he was cut off by the chair.

ROGER DAVIS PHD
Patient with complications. Clinical psychologist.

Dr. Davis talked about his involvement with The Surgical Eyes Foundation, and having studied 300 complications patients 100 of whom indicated they had experienced suicidal ideation. 83% of those indicated they had been told their surgeries were successful.

In his study he found that dry eye syndrome was more closely associated with depression than any other complication.

Dr. Davis’ term for the psychological phenomena these patients experience is Refractive Surgery Shock Syndrome.

He went over the “stages of inquiry” complications patients go through. I did not catch all the details but it definitely struck me as the most compelling attempt of the day to put people into the head of the LASIK patient. Towards the end of that part he discussed the different paths patients take and where those lead them, including:
- Some patients travel all over the world to specialists, fail to get effective treatment, and just want to be at the end of their journey. [Hence suicides.]
- Some start websites, in order to get some empowerment.
- Some are just barely coping, and have no energy left over for activism.
- Some feel no one anywhere understands them, and that by taking their lives at least people will finally understand how much they have been impacted by their surgery.

Dr. Davis called for the FDA study to look into informed consent and the standard of care. He also said “Forget the quality of life survey. Study the suicidal patients.” He called for a moratorium on LASIK.

JOANNE WILLS on behalf of KEITH WILLS?
Complications patient.

I only caught the barest scraps of this one. LASIK in 1997; part of an investigational study but the patient was not told. Had 7 surgeries to correct initial problems.

SOMEONE FROM MILITARY

I was preoccupied during this one. The speaker expatiated at some length on safety issues for soldiers in the field, and the benefits of LASIK.

JOSEPH SCHNELL
Complications patient.

Mr. Schnell underwent LASIK in 2007 at Lasik Plus. He said something about Scheie Eye and Wilmer – I am not sure if these are places he went for treatment afterwards. He considers his eye health much worse after surgery and described vision quality problems. He described anxiety attacks and other effects the surgery has had on him.

I am pretty sure this was the end of the scheduled speakers – at any rate it’s all I’ve got notes on. Sorry if I left anybody out.

ED BOSHNICK OD
Optometrist

Dr. Boshnick is one of several optometrists who have put a lot of time into treating complications patients with specialty contact lenses. I did not have any notes on what he said because I was hastily scribbling some notes for myself as I had just been called.

REBECCA PETRIS
President, LaserMyEye Inc. (501(c)(3) nonprofit) and founder/owner, The Dry Eye Company

Oops, that’s me!

I had previously sent in a letter to the FDA for the hearing’s written records. I had also missed the deadline to request a speaking slot, and felt that with the crowds who wanted to speak, it was extremely unlikely I’d be called on. I did not prepare a speech, and even if I had, after witnessing the morning’s proceedings, I don’t think I could have brought myself to read it.

Instead, I winged it. It was a bit of a blur afterwards, but I’ll share some bits and scraps that I remember.

I told the panel briefly about my change of career as a result of my LASIK, how I founded LaserMyEye and later The Dry Eye Company. I told them how grateful I was for the opportunity to speak and how I had missed the deadline to request a speaking slot because of being preoccupied with my work with people with dry eye. I told them I had flown out from Seattle on the last redeye flight Thursday night to attend the hearing because I had not been able to tear myself away from the phone.

I described a two-hour conversation that Thursday morning with a young man in Arkansas who was near suicidal as a result of his struggles after undergoing LASIK just 3 months ago, and I talked of how many of these conversations I have regularly with people 3 months, 6 months, 1 year, or many years after their surgery. I talked about unremitting pain from dry eye and what it does to people.

I told them that as regards depression, I agreed with the presenter who insisted that depression does not come from a single event. I said that for patients it’s not a single event (surgery) – it’s what came before (poor screening, poor informed consent) and what came after – complications, poor care, lack of validation, inadequate treatment, and pain, pain and more pain.

I said that there were many doctors in the room and I wished they could be flies on the walls of my office on a typical day to hear the calls from patients looking for help. I said that we had heard a lot from LASIK surgeons that day about improvements to technology and about how exciting all the capabilities of LASIK are. I said that what we had not heard was any compassion for those who experienced problems. I said that if there were any compassion to be had, the doctors and professional organizations should be rallying around the consumer groups offering practical help and support for complications patients.

------

This was followed by a few questions from the panel for one or two of the doctor speakers. That was pretty much it for the public hearing part of the day’s proceedings.

4/25/08 FDA LASIK Hearing: The open public hearing (1 of 2)

Now that I’ve gotten warmed up, I’ll move on to the proceedings themselves.

The whole of the morning (8:45 to 11:30 am) was dedicated to pre-scheduled speakers, that is, people who had requested to be allowed to give a presentation about the "post-market experience". This opportunity was open to anyone and there was quite a variety of speakers as you'll see.

Each speaker was strictly limited to 5 minutes maximum. I'll take them in the order they presented. Apologies in advance to anyone whose name I didn't catch or have made mincemeat of.

NOTE: Throughout the notes I took, I used the shorthand “NVD” (night vision disturbance) whenever anyone referred to starbursts, haloes, “glare”, etc. So when I use that phrase in my descriptions below, it’s probably not what the person said, it’s just the term I use for it.

MICHAEL PATTERSON PHD
Patient with complications.

I've known Michael via email for several years and met him for the first time at the meeting.

Some highlights I noted from his presentation had to do with post-market surveillance, an area of FDA "un" or "under" activity that I fully agree about. The FDA has some voluntary and mandatory reporting requirements for surgeons and manufacturers but it's no secret that adverse events are woefully underreported. Michael was very critical of the FDA's inaction in the face of a manifest widespread problem with underreporting of excimer laser related adverse events.

Michael, like several later presenters, called for (among other things) a moratorium on LASIK.

DEAN KANTIS
Complications patient, LASIK critic and activist.

He shared quite a lot from his personal experience, including being sued by his doctor for publicly exposing the 40 lawsuits against his doctor. He claimed his family has been harassed and that he has even been subject to death threats.

Dean's key 5 points were about:
1) The truth about "the flap" and about pupil size.
2) Informed consent improvements that are needed.
3) Definition of a LASIK success. (This is a point raised many times throughout the hearing - the disconnect between what a surgeon calls a success and what a patient calls a success.)
4) The problem of post-market reporting of adverse events and how to enforce reporting of them if the FDA is not enforcing it.
5) The unseen emotional problems - depression and suicidal patients.

DAVID HARTZOK OD & BARBARA BERNEY
(statement read on their behalf by Glenn Hagele)
Representing Vision Surgery Rehab Network, a nonprofit 501(c)(3) group for complications patients. VSRN is the successor to The Surgical Eyes Foundation, a nonprofit founded by Ron Link that worked for many years on behalf of complications patients starting in the late 1990s.

The panel must be prepared to hear two extreme arguments today. VSRN believes both extremes are disingenuous.... We would like to start a dialogue with the FDA.

I was puzzled by the use of the word 'disingenuous'. I've often heard, and sometimes used, this word or synonyms in relation to the LASIK industry, but whatever criticisms the 'extreme' activists might at times lay themselves open to, being deliberately dishonest is not something I would ever associate with them. I think they are passionate and dedicated people even if I have differences of opinion or judgment.

With this single exception, I thought the VSRN presentation was excellent. The focus was on "Refractive Surgery Syndrome", comprised of physiological and psychological sequellae of LASIK and similar surgeons. They emphasized the critical importance of how doctors manage a patient with a poor outcome; and how the RSS problem was compounded by ineffective treatment. They asserted that wavefront has not eliminated the vision quality problems of the past. They talked on the theme of acuity (20/20 etc) as an inadequate measure of "success".

Bottom line:

There is a significant but unknown number of patients with Refractive Surgery Syndrome.

GERALD DORRIAN
Father of Colin Dorrian, who committed suicide in 2007, 6 ½ years after his LASIK.

Mr. Dorrian's talk was all the more poignant for being remarkably calm and measured. He described his son, a law student at University of Michigan with no mental illness history.

Colin was contact lens intolerant and had large pupils (two big red flags in my book – but which are routinely overlooked or dismissed by many laser clinics). He was told he had less than 1% chance of a worsening of any night vision complaints. After surgery, his long-term effects included starbursts/haloes, loss of contrast sensitivity, and dry eye. He made three different attempts at specialty gas permeable lenses, which are the safest and most effective form of treatment for these vision disorders, but was not successful.

Mr. Dorrian read from a letter Colin had written not too long before he took his life. In it he acknowledged he might even have “tended” to be a bit on the depressive side before but that until LASIK, he always managed to get by and bounce back.

Mr. Dorrian stated that people involved in refractive surgery need to take responsibility for the problems, not just broadcast the successes. He was then cut off as he had reached the 5 minute limit.

SANDY KELLER
Patient with complications. Founded (but does not currently run) www.lasikdisaster.com, a longtime popular website for information on complications. She was not present but a statement was read on her behalf by Glenn Hagele.

Sandy was one of the early LASIK patients with horrific complications and badly botched post-operative care. She had risk factors before surgery (large pupils, dry eye). The blade jammed during surgery. She developed Stage IV DLK. She found information and support from The Surgical Eyes Foundation (predecessor to VSRN as mentioned). She describes the betrayal she felt when she learned the financial particulars of the “co-management” arrangement between her surgeon and optometrist. She sued them and they each blamed each other. Her medical records were altered.

She described her emotional experiences as similar to PTSD. Her business suffered and she said that at times she wanted to die. At this point the reader lost composure and the chair proceeded to call another presenter. If there was any more to her statement I don’t think it was read.

DOMINIC MORGAN
Patient with complications and activist. Founded and runs www.lasikdecision.com.

Dom was another of the early LASIK patients with a true horror story. His surgery was performed with improper use of an investigational device. He never should have been a candidate as he had blatant contraindications (he was 20/50 BCVA and had retinopathy of prematurity). He states the he and many others were dropped from a study because of their complications.

His doctor sued him for publicizing details on his website.

He states that he filed a petition to the FDA in 2003 which was ignored.

Dom says that he has been contacted by hundreds of patients via email, some suicidal. He describes them as “ordinary people” with nothing to suggest they are “perfectionists” or have other characteristics physicians use to explain or dismiss dissatisfied patients.

Dom was critical of the involvement of ASCRS in the study that the FDA is undertaking and suggested that patients have no more reason to trust an organization of LASIK surgeons more than they trusted their individual surgeon. He suggested that it would be interesting to conduct a survey asking how many patients with complications feel they were lied to.

Dom concluded by suggesting that a moratorium on LASIK advertising would be an intriguing idea. I have an additional scribble in my notes that looks like “Patient selection or doctor selection?”

DAVID SHELL
Patient with complications.

David was another of the early (1998) complications patients. A former engineer, he described how after 50 years of healthy eyes he underwent LASIK and is now handicapped by constant eye pain and strain, and experiences distorted vision even with specialty gas permeable lenses.

David provided some images on posters to show how someone with, technically, good acuity can still have horrible vision. The posters showed a snellen eye chart with ghosting; pictures of starbursts on lights; and multiple moons.

In 2002 David testified to the FDA about LASIK dry eye, describing the constant burning and stinging and how his eyes never feel comfortable. He has been to experts around the country seeking treatment.

David called on the FDA to do three things:
1) Reclassify night vision disturbances (starbursts, haloes, glare and the like) and dry eye syndrome as a complication.
2) Conduct a truly independent study
3) Re-examine the safety and effectiveness of LASIK.

BARRY ELBASANI
(sp?) Patient with good results. He was not there personally but a statement was read on his behalf by Glenn Hagele.

Barry is paralyzed from the chest down due to a pool accident. He described how since his accident so many things that most people consider trivial are now much more difficult – including dealing with glasses or contacts. Being paralyzed he cannot even put them on and take them off by himself. Getting LASIK was a huge benefit to him because it’s one area of his life that he does not have to be dependent on others for.

GLENN HAGELE
President of CRSQA, a doctor referral/certification service. Runs www.usaeyes.org.

Glenn stated that quality of life has always been the yardstick for LASIK, and that expectations are central to patient satisfaction. I was rather taken aback when Glenn asked the ‘casualties’ (people with poor LASIK results) in the audience to raise their hand. I did not raise mine. I suppose the show of hands was a help to the press in finding people to interview, but personally I felt it was inappropriate.

Glenn presented results from his “CORE Survey”, a patient satisfaction survey conducted between March 3 and April 16 with a 31% response rate. 99% said that their quality of life was as expected or better.

Glenn did not present the data on night vision symptoms or dry eye “due to time constraints”. Most unfortunate, from my view, considering that night vision symptoms and dry eye are acknowledged to be the most frequent causes of complaints.

DIANA ZUCKERMAN PHD
President of the National Research Center (NRC) for Women & Families. Expert on national health policy and women’s health.

Dr. Zuckerman mentioned that there were a lot of problems with surveys that rely on subjective assessment and self-reporting “such as you have just heard”.

She told us that there was very good information available about LASIK on the FDA’s website – “but who reads it?” She was also critical of the FDA’s patient information booklets as being far too sophisticated for the average reader, even going so far as to state that they read as though they are designed to satisfy someone at the FDA without respect to what actually helps patients.

She talked about eye pain and dry eye as being the most common complaints (hear, hear!!) and referred to specific study numbers in the 20% range at 6 months post-operatively.

She said that the possibility of an unusually high suicide rate has been raised and needs to be researched.

Dr. Zuckerman concluded with the statement that overall, patients do not have informed consent. Healthcare practitioners are focused on the consent rather than the information. Informed consent is a process, not a piece of paper.

LAURANELL BURCH PHD
Patient with complications.

Dr. Burch accused the industry of trying to re-frame the discussion the FDA has opened. She said that Dr. Kerry Solomon had been quoted as saying “This is not about safety and effectiveness”, but she felt that if this was true, “We would not be here”.

She raised many future health concerns for eyes that have undergone LASIK and felt that nobody would get LASIK if these were fully understood. She cited specific examples, including:
- Flap-related issues (non-healing; structurally weakened cornea at risk of ectasia)
- Potential complications for future cataract surgery
- Potential inaccuracy of intra-ocular pressure measurements

Dr. Burch stated that patient satisfaction surveys are not the right target and that instead we should be measuring vision quality loss and dry eye syndrome. (Hear, hear.)

MATT KOTSOVOULOS
Patient with complications.

Matt’s situation is quite different from some of the other patients because his surgery is recent (2006) and took place with the very latest technology (Intralase and wavefront) at a highly reputed center (Duke University, where he was CFO of the eye center at the time of his surgery).

Since his surgery, Matt says he experiences constant eye pain. He complained of unethical marketing, and specifically referred to dry eye and night vision problems being classed as “symptoms” rather than complications. Like Dr. Zuckerman he referred to an OSU study showing a 20% rate of worsened dry eye symptoms after LASIK and 15% night vision symptoms.

Matt said that the LASIK industry wants to use a high satisfaction rate to imply a low complications rate, but asserted that these are two entirely different matters.

Matt said he has met plenty of people who are depressed or even suicidal because of “side effects” not classed as complications.

In conclusion he called for a moratorium on LASIK, and wants to see studies of complications including depression. He wants night vision disturbance and dry eye syndrome to be classed as complications.

BETH KOTSOVOULOS
Wife of patient with complications

I noted this one down as one of the most compelling of the day. It gave us a snapshot of what a poor outcome of LASIK does to your average American family.

Beth described how severe dry eye “almost destroyed our family”, how Matt experienced post-traumatic stress disorder and suicidal ideation.

She called on the surgeons present to try to be objective about this and really listen to what patients are experiencing when they have these kinds of results.

Her message to the media was also clear: The minority matter – not just the happy majority.

She called for an investigation into the link between LASIK and depression, and referred to many examples including:
- Two LASIK suicides. (Note: These are in addition to any other suicides discussed Friday morning. Incidentally, one of them is a patient I was personally closely acquainted with.)
- An army major currently stationed in Iraq (side note – he is a longtime member of Dry Eye Talk known to many in the online dry eye community)
- A lady named Linda who underwent cancer 10 years ago and never experienced depression, but who found that a 20-minute eye surgery turned her life upside down.

Beth described LASIK complications as wreaking havoc on American families – not as the straw that breaks the camel’s back but as the 200 lb gorilla. Her last remark before being cut off by the time limit was to call on the FDA to investigate clinical depression and suicide connected to LASIK.

4/25/08 FDA LASIK Hearing: LASIK and the military

I can’t think of a single thing that got my back up at Friday’s hearing so much as the military brass. I went from being merely curious when I walked in that morning and saw all the uniforms in the room, to being very sore by the end of the day.

Very, very sore.

Here is why.

ONE

I’d like to know who invited the DOD, and accorded them special treatment, and why.

Military personnel had their opportunity along with the rest of us in the public hearing session. The 29th presenter (by my count... and unfortunately the only one whose name I did not catch) expatiated at length on the benefits of LASIK to the military, and this was further bolstered by comments from a military man speaking on behalf of Doyle Stulting MD and also from (ex Navy) Steve Schallhorn MD. Fair enough.

But why was the military given the opportunity to hold a 15 minute cheerleading session for LASIK Friday afternoon during the FDA/ODP sessions?

Enquiring minds want to know.

TWO

If Friday’s presentations are anything to judge by, I believe the military are in denial when it comes to dry eye from LASIK and PRK – its incidence among military personnel; its impact on the safety and wellbeing of our active duty service people; and its impact on our veterans.

I listened carefully for the words “dry eye” during those presentations. Presenter #29 did not mention it. Commander Tanzer in his 15 minute session did not mention it even in his listing of complications.

Why? It is well established in all the published medical literature as the most frequent problem after LASIK and has been for many, many years. Even the Journal of Refractive Surgery, printed a study in April concluding “LASIK-induced dry eye and neurotrophic epitheliopathy are common complications of LASIK surgery....” It's no secret.

Yet the Navy’s apologist for LASIK did not deign to spare even 15 seconds of his 15 minutes to pay a little lip service to this well known problem.

We were told that 224,000 procedures have been performed on the military.

I have three questions about this:

1. Has anyone bothered to find out how many of those people have chronic dry eye?

If you have, great, show me the numbers! But they had better be real numbers using a scientifically validated instrument to measure patient symptoms, such as the OSDI.

Until you take the trouble to do this, it’s not hard for us to calculate a probable minimum number. Based on the published medical studies, it could be anywhere from 5% to 36%. (Figures like 15-20% at 6+ months postop were mentioned many times Friday as there are many excellent studies with numbers in that range.) But this is the military, meaning it’s younger and much more male-dominated than the LASIK market at large. And they’re almost certainly getting better treatment than the local 2-for-1 bait-and-switch laser clinic. So let’s give them maximal benefit of the doubt and suggest the actual rate to be as low as 5%. That’s, let me see, a mere 11,200 military service people. Clearly not important enough to tell the FDA or the American public. Especially when glowing reports of increased safety and even “super-vision” are so much more exciting and inspiring.

2. Has anyone investigated how severe or chronic dry eye from LASIK is affecting active duty military and what kind of care they are getting?

Sorry, I didn’t catch your answer. Come again?

3. Has anyone investigated how dry eye from LASIK is affecting our veterans and what kind of care they are getting?

I didn’t think so.

Moving on now from statistics and probabilities to particulars and facts:

Does Commander Tanzer know how many people are registered in our D’Eyealogues forums for LASIK complications patients, or our DryEyeTalk forums for dry eye patients, with email addresses ending in .army.mil, or .navy.mil, or .af.mil?

I do.

Does Commander Tanzer know how many military personnel have registered in these forums under yahoo or gmail accounts?

I don’t either.

Does Commander Tanzer know how many of my customers for moisture chamber goggles and such are active duty military?

I do. (Except, of course, for the ones whose families are purchasing them and sending them on.)

Does Commander Tanzer know any military doctors with severe dry eye stationed in Iraq right now?

I do.

Does Commander Tanzer know any military personnel stateside who have been cast to the winds by the VA - while struggling with, say, recurrent erosions more than a year after PRK? People who now have to pay out of pocket for everything they need – moisture goggles, over-the-counter lubricants, and so on?

I do.

THREE

I’d like to know exactly what kind of informed consent our military is getting when they undergo LASIK.

Informed consent is a serious problem for us civilians. What is the military doing to make sure their personnel understand the real risks of dry eye and night vision disturbance?

The military spoke eloquently Friday about the benefits of LASIK to soldiers in the field, compared with risks of glasses or contacts.

But I’ll wager that some soldiers could speak even more eloquently about what it’s like to get a spontaneous erosion out there in the field. I’ve had women tell me that giving birth was far less painful than the corneal abrasions they've had since they got LASIK dry eye. Now I know our military are tough folks and are willing and able to withstand a great deal in service to their country, but to the extent they have to suffer, I do not want it to be as a result of a procedure they voluntarily underwent in order to become more efficient for their country - without being accurately and fairly informed of the risks by those whose job it is to promote their wellbeing.

I challenge Commander David Tanzer, the United States Navy, and the Department of Defense to take a closer look at the other side of the LASIK coin.

I’d better stop now before I get really worked up.

We’ve all got our biases. Here’s mine: I’m one of the people quietly trying to help pick up the pieces when someone’s great plans for someone else’s eyes have unintended consequences. You’d better believe it’s left me with some chips on my shoulder, and what’s more, I’m not ashamed of it.

4/25/08 FDA LASIK Hearing: Trivia and miscellaneous observations

On the merits of glasses

Dr. Jayne Weiss, chair of the Ophthalmic Devices Panel for the 4/25 meeting, kindly forestalled the inevitable press commentary on how many panel members were wearing glasses by pointing it out herself and challenging her colleagues to explain themselves. So why does Dr. Weiss (a LASIK surgeon) not get LASIK?

Two reasons:

First, I like my near vision. If I were to get LASIK, I would not be able to see up close without glasses anymore.

Second, I am not willing to put my eyes at ANY risk.

On financial conflicts of interest

By the end of the public hearing, this refrain was running through my head like a really bad but catchy country song:

Hello, my name is Dr. So-and-so.... and I'm a paid consultant to AMO....

For those who don’t follow this stuff, Advanced Medical Optics owns (a) VISX, the US market leader in excimer lasesrs (that’s the machine used to “reshape” corneas) and (b) IntraLase, the ‘hot technology’ of LASIK – a femtosecond laser which makes LASIK flaps without a blade.

I lost track of how many actually are AMO consultants, but I don't recall there being any ophthalmologists presenting during the public hearing who did NOT acknowledge any industry financial conflicts. If anyone has information contradicting that, please set the record straight for me.

That sort of stuff goes right over the head of today's media. All they hear are the half-page of credentials immediately after the name.

On bad science and unequal standards

The hearing had its high points and its low points.

One of the lowest of the lows was something about pupils, the significance of which the press could not possibly have picked up on and probably went right over the head of most of the attendees as well.

At least two presenters, Dr. Steve Schallhorn and Cmdr David Tanzer (I'll talk more about the latter in an other post about the role of the DOD in Friday's meeting) referred to one of Dr. Schallhorn's studies indicating pupil size is not predictive of vision quality/night vision disturbances. At the end of the meeting when chair Dr. Weiss was summing up changes agreed upon for the FDA's LASIK pages, she indicated that the warnings about pupil size need to be brought up to date with current literature.

What Dr. Weiss (with whom, incidentally, I was quite impressed throughout the proceedings) presumably was not aware of is that Dr. Schallhorn's pupil study has been completely discredited by numerous other studies and letters to the editor. Methodology for eliciting the dark-adapted pupil size of the study subjects is fundamental to the reliability of any such study and his numbers were simply indefensible in the context of the mean DAPD for each age group as established in the medical literature by national experts. I hope and expect that the interested experts will set her straight on this before they actually change - i.e. REMOVE or water down - a vital warning on the FDA website to people with large pupils.

What I found so ironic in this situation is that Dr. Weiss as chair of the ODP readily accepted and recommended to the FDA that they change their website language on the basis of a single study mentioned during the meeting.

At the same time, the ODP did not hesitate to brush off consumer advocate Paula Cofer's recommendation of a warning about a decrease in corneal keratocyte density with unknown long term complications. On what basis? That it was based upon a single study. Apparently if the study author, or the DOD, mentions it, it can safely be assumed to be prevailing science, while if a consumer mentions it, they don't know what they're talking about.

Lastly... and unrelated specifically to this hearing, but I mention it because it has always irked me exceedingly... is that whenever I've heard Dr. Schallhorn talk about this pupil size issue, (a) he maintains that his studies show that pupil size is not predictive of NVD complaints, YET nonetheless (b) he hastens to add that they ALWAYS measure dark-adapted pupil diameter anyway, but don't use that information in surgical planning. (Excuse me, but why measure it if you are perfectly convinced it is irrelevant and if you are not going to use it?)

Product news: MEG update

I spoke with Dr. Yee's office today and they said that the MEG is expected to be available at the end of July. Internet sales only.

Study: Bunnies and BAC, and why we should care!

OK so we already know that BAC (BAK) is bad bad stuff for the corneas, but the problem is, it's still out there in nearly all commonly prescribed ophthalmic medications including most glaucoma drops.

And while I'm on the subject... if you want to know how much is in the drops you are prescribing or have been prescribed, please visit our preservative reference list.

So along comes this lovely new rabbit model showing how JUST TWO WEEKS of BAC twice daily in a concentration just 5x what's in Xalatan did ALL of the following:
- caused dry eye syndrome
- damaged the cornea and conjunctiva
- decreased aqueous tear basal secretion and
- caused goblet cell loss and MUC5AC deficiency

I sure hope the glaucoma docs are following this literature carefully and prescribing accordingly.

A Rabbit Dry Eye Model Induced by Topical Medication of a Preservative Benzalkonium Chloride.
Xiong C, Chen D, Liu J, Liu B, Li N, Zhou Y, Liang X, Ma P, Ye C, Ge J, Wang Z.
Invest Ophthalmol Vis Sci. 2008 May;49(5):1850-1856

PURPOSE: To establish a rabbit dry eye model with topical medication of the ocular preparation preservative benzalkonium chloride (BAC). METHODS: Sixteen white rabbits were used. One eye of each rabbit was chosen randomly for topical administration of 0.1% BAC twice daily for 14 days. The other untreated eyes served as controls. Schirmer test, fluorescein, and rose bengal staining were performed before and after BAC treatment on days 3, 5, 7, and 14. Conjunctiva impression cytology specimens were collected on days 0, 7, and 14. The rabbits were killed after day 14. Immunofluorescence staining was performed to detect mucin-5 subtype AC (MUC5AC) on conjunctival cryosections. Cornea and conjunctiva structures were evaluated by light and electron microscopy. RESULTS: Compared with untreated controls, BAC-treated eyes showed significant decreases in Schirmer scores (P = 0.01) and increases in fluorescein scores (P < 0.001) on days 5, 7, and 14. A significant increase in rose bengal scores was noticed as early as day 3 (P = 0.001). Decreases in goblet cell density occurred on days 7 and 14 (P = 0.001). Decreased MUC5AC and histopathologic and ultrastructural disorders of the cornea and conjunctiva were also observed in the BAC group. CONCLUSIONS: These findings demonstrated that an ophthalmic preservative, benzalkonium chloride, induced a dry eye syndrome in rabbits with damage to the cornea and conjunctiva, decreased aqueous tear basal secretion, goblet cell loss, and MUC5AC deficiency. This rabbit model was consistent with human dry eye syndrome in both aqueous tear and mucin deficiency and may be appropriate for studying dry eye syndrome.

Study: Sjogrens, corneal nerve morphology and eye pain

This is an intersting study from Finland despite grotesquely long phrases like "neuropathic corneal mechanical hypersensitivity induced by ocular surface inflammation". Put simply, they're trying to figure out how to match what your nerves look like to how you feel. What they found is that nerve density didn't seem to matter but features of the nerves themselves (thickening, sprouting) did.

Alterations in corneal sensitivity and nerve morphology in patients with primary Sjögren's syndrome.
Tuisku IS, Konttinen YT, Konttinen LM, Tervo TM
Exp Eye Res. 2008 Mar 12

The aim of the study was to assess subjective symptoms and objective clinical signs of dry eye in relation to corneal nerve morphology and sensitivity in primary Sjögren's syndrome. Twenty eyes of 20 primary Sjögren's syndrome patients and ten eyes of 10 healthy age- and sex-matched controls were included in the study. Ocular surface disease index (OSDI) questionnaire and visual analog scales were used to assess subjective symptoms. The mechanical sensitivity of the central cornea was measured using a modified Belmonte non-contact esthesiometer followed by an analysis of corneal nerve morphology using scanning slit confocal microscopy (ConfoScan 3). OSDI symptom scores were high in primary Sjögren's syndrome patients, compared with controls. Accordingly, the mean corneal detection threshold was low in patients implicating corneal mechanical hypersensitivity (54.5+/-40.1ml/min vs. 85.0+/-24.6ml/min, P=0.036). However, nerve densities were similar, and no correlation was present between corneal sensitivity and nerve density. In contrast, alterations in nerve morphology were found; stromal nerves appeared thicker, and nerve growth cone-like structures were seen in 20% of patients, often associated with dendritic antigen-presenting cells. Sjögren's syndrome patients presented with corneal mechanical hypersensitivity, although corneal nerve density did not differ from controls. However, alterations in corneal nerve morphology (nerve sprouting and thickened stromal nerves) and an increased amount of antigen-presenting cells, implicating the role of inflammation, were observed. These observations offer an explanation for the corneal mechanical hypersensitivity, or even hyperalgesia often observed in these patients. We hypothesize that patients with primary Sjögren's syndrome dry eye suffer from neuropathic corneal mechanical hypersensitivity induced by ocular surface inflammation.

Study: Moooooore on bandage contact lenses

Those of you who use bandage lenses to manage dry eye or RCEs will want to keep an eye on this development. Doesn't appear to have a great deal of detail just yet but I'd love to see more on it when they are further along. Basically it's contact lenses made of bovine collagen (instead of the classic silicone hydrogels etdc) used therapeutically.

Clinical Evaluation of Succinylated Collagen Bandage Lenses for Ophthalmic Applications.
Hadassah J, Prakash D, Sehgal PK, Agarwal A, Bhuvaneshwari N.
Ophthalmic Res. 2008 Apr 25;40(5):257-266

Aim: To study whether succinylated collagen bandage lenses (SCBL) prepared from modified bovine collagen (succinylated collagen) can replace other bandage lenses presently employed to treat various corneal conditions like filamentary keratitis, dry eyes, recurrent corneal erosions, foreign body removal and epithelial trauma. Methods: This observational case study included 32 patients (22 female and 10 male): 8 patients for filamentary keratitis (25%), 10 patients for dry eyes (31%), 4 patients for recurrent corneal erosions (13%), 7 patients for foreign body removal (22%) and 3 patients for epithelial trauma (9%). Their eyes were evaluated for biocompatibility, in vivo transparency, patient comfort, corneal fit, best corrected visual acuity (BCVA), tear fluid level and dissolution rate of SCBL. This was carried out over a 24-hour period of time. Results: SCBL exhibited good transparency and remained transparent throughout the period of study (between 0 and 24 h) in the eyes of patients. SCBL did not cause any irritation, discomfort and foreign body sensation in the eye and eyes remained comfortable throughout the experiment. BCVA in the control group of patients was 1.00 (20/20). Mean (+/-SD) BCVA before inserting SCBL (in decimal equivalent) was 0.31 (20/60) +/- 0.18 (range 0.1- 0.66). BCVA (+/-SD) changed to 0.25 (20/80) +/- 0.18 4 h after the application of SCBL and 0.27 (20/70) +/- 0.18 24 h after the application of SCBL, with a safety index of 1.20. The mean (+/-SD) tear fluid level before application of SCBL was 11.9 +/- 5.39 h (range 3-24 mm) and changed to 13.9 +/- 5.68 h (range 5-28 mm) after 4 h of application of SCBL and 15.9 +/- 5.72 h (range 7-30 mm) after 24 h with a safety index of 13 mm. The mean (+/-SD) dissolution rate of SCBL in the control group of patients was 17.8 +/- 8.65 h (range 10-24 h) and the mean (+/-SD) dissolution rate in the experimental group was 22.2 +/- 9.29 h (range 10-24 h). We report the use of SCBL in various corneal conditions. Conclusion: The present study showed that SCBL has complete corneal fit and good comfort in human eyes. Transparency was maintained for a longer period along with fair visual acuity and improvement in tear fluid levels. The disadvantages of other bandage lenses presently used to treat various corneal conditions could be overcome by the use of SCBL lenses.

Study: SmartPlugs vs. silicone punctal plugs

Well, well. After a number of relatively negative studies involving SmartPlugs finally we get an attempt to vindicate them.

But, ahem, not necessarily a terribly effective attempt. 11 weeks is a grossly inadequate follow-up period if you ask me. After all, the key concerns with punctal occlusion are long term safety and retention. Most of us plan on having our plugs in a lot longer than 2.5 months, and many of the reports of SmartPlug problems occurred well beyond that period.

Speaking of which, 33% loss of the punctal plugs within 11 weeks is clearly excessive. I'd like to know how carefully they were sizing these patients before plopping the plugs in and whether the plugs were all one brand. Incidentally, docs, you may find the plugs reference pages in our Dry Eye Encylopedia very handy if you want to get an idea of all the sizes available of all different brands of plugs for those hard-to-fit patients.

SmartPlug Versus Silicone Punctal Plug Therapy for Dry Eye: A Prospective Randomized Trial.
Burgess PI, Koay P, Clark P.
Cornea. 2008 May;27(4):391-394.

PURPOSE:: To evaluate the clinical efficacy, retention rates, and complications of SmartPlug insertion compared with silicone punctal plugs in patients with dry eye. METHODS:: Thirty-six eyes with subjective symptoms of dry eye in addition to a tear film breakup time (TBUT) <5 seconds and evidence of ocular surface damage on rose Bengal or fluorescein staining were included. Treated eyes were randomized to either a silicone plug or SmartPlug inferior punctal occlusion. Pre- and posttreatment evaluations included subjective symptom scoring, tear meniscus height, TBUT, Schirmer test, fluorescein and rose Bengal staining, and artificial tear use. RESULTS:: After a mean follow-up period of 11.2 weeks, both the silicone plug- and SmartPlug-treated eyes showed significant improvement in symptom scoring (P = 0.002 and P = 0.005, respectively), TBUT (P = 0.035 and P = 0.009, respectively), and fluorescein (P = 0.024 and P = 0.016, respectively) and rose Bengal (P = 0.008 and P = 0.046, respectively) staining. There was no significant difference in these parameters between the 2 plugs. SmartPlug-, but not the silicone plug-treated eyes showed significant improvement in mean tear meniscus height (P = 0.037). The use of artificial tear supplements was reduced in 10 (55.6%) silicone- and 11 (61.1%) SmartPlug-treated eyes. Minor complications related to plug insertion were experienced in 4 (22%) silicone- and 2 (11%) SmartPlug-treated eyes. Spontaneous plug loss occurred with 6 (33%) silicone plugs. CONCLUSIONS:: This prospective randomized trial shows that SmartPlug insertion has equivalent clinical efficacy to the use of conventional silicone plugs. Both SmartPlug and silicone plug use can reduce dependency on tear supplements in >55% of patients with dry eye.

Abstract: UK optometrists and what they do

I thought some of our British readers might be interested in this one. It seems as though very, very few of our UK dry eye folk are satisfied with the dry eye care they are getting from ophthalmology. Maybe as optometrists increase the scope of their therapeutic practice they can be encouraged to play a larger role in dry eye just as is happening on a large scale in the US.

A survey of the scope of therapeutic practice by UK optometrists and their attitudes to an extended prescribing role.
Needle JJ, Petchey R, Lawrenson JG.
Ophthalmic Physiol Opt. 2008 May;28(3):193-203

Purpose: Recent changes in medicines legislation in the UK have broadened the opportunities for optometrists to use and supply therapeutic drugs. We set out to investigate the current therapeutic practice of UK optometrists and to elicit their views on an extended prescribing role. Methods: Members of the College of Optometrists were invited via email to take part in an online survey. The survey questions covered four areas: mode of practice, proximity and relationship to other providers of eye care, scope of current therapeutic practice and future plans regarding prescriber training. Results: Of the 1288 responses received (response rate 24%), over 90% were from optometrists working in community practice. Common, non-sight-threatening conditions were managed frequently or occasionally by between 69 and 96% of respondents. Blepharitis and dry eye were the most common (managed routinely by >70%). In terms of therapeutic agents used, large numbers of optometrists reported that they commonly supplied or recommended over-the-counter (non-prescription) drugs, particularly lubricants and anti-allergic agents. However, fewer respondents supplied antibiotics (only 14% supplying chloramphenicol or fusidic acid frequently). Overall, relatively few respondents (14%) expressed no interest in undertaking further training for extended prescribing, although several barriers were identified, including cost and time taken for training, lack of remuneration and fear of litigation. Conclusion: Significant numbers of community optometrists are currently managing a range of common ocular conditions using a limited formulary. Enabling optometrists to train as independent prescribers will further develop this role, allowing greater use of their skills and providing patients with quicker access to medicines.

Drug news: Resolvyx / RX10045

According to a recent news report, Resolvyx Pharmaceutical (Bedford MA) is planning some dry eye drug trials for later this year.

Resolvyx are a little off the beaten track but on a track that many dry eye patients (especially auto-immune types) might find interesting, as it's all based on research into Omega 3s. They are apparently aspiring to develop drugs for a host of inflammatory auto-immune conditions.

Bedford biotech gains steam and attention
April 22, 2008

Resolvyx Pharmaceuticals Inc., based in Bedford, hopes to use recent scientific research on how omega-3 fatty acids work to develop a powerful new class of drugs to treat inflammatory diseases, ranging from asthma to cardiovascular problems....

Cofounder Charles Serhan, a scientist at Brigham and Women's Hospital in Boston, found evidence that omega-3s are important because the body uses them as raw materials to create another set of compounds, called resolvins, which help regulate the immune system. Without enough resolvins, the body has trouble stopping inflammation - a key way it fights off disease - after the threat has passed, contributing to an array of diseases, including arthritis....

So far, the company has only tested its drugs in rodents, such as asthmatic mice. But Resolvyx plans to test one compound, RX-10045, in humans this year to treat dry eye. And within the next year, it plans to launch clinical trials for another compound, RX-10001, to treat asthma. Resolvyx eventually hopes to determine whether the drugs can effectively treat more conditions, including rheumatoid arthritis, inflammatory bowel disease, cardiovascular diseases, and other eye problems.

Study: RA, bad genes and dry eye

This is one of those numbers-heavy studies relating dryness in rheumatoid arthritis patients to genes... of interest perhaps to the research diehards if not to me personally....

[The presence of dry eye syndrome and corneal complications in patients with rheumatoid arthritis and its association with -174 gene polymorphism for interleukin 6]
Polanská V, Serý O, Fojtík Z, Hlinomazová Z.
Cesk Slov Oftalmol. 2008 Mar;64(2):77-80

The aim of this study was to evaluate the presence of the dry eye syndrome and corneal complications in patients with rheumatoid arthritis and to assess its association with the -174 gene polymorphism for interleukin 6. The group consisted of 123 patients treated for rheumatoid arthritis (20 men, 103 women); the mean age was 53 years (+/- 13.6). Every patient had completely ophthalmologic examination and special attention was paid to the amount of tears. The presence of corneal complications was detected in the medical history and evaluated during the slit lamp examination. In all patients the polymorphism-174 IL-6 examinations were performed. For the statistical data processing, the chi square (chi2) test for nominal variable was used. The dry eye syndrome (DES) was found in 98 eyes (79.7%), severe dry eye syndrome was detected in 53 patients (43.1%). Corneal complications appeared in 9 patients (7.3%). DES was present in 32 patients with the GG genotype (91.4%, n1 = 35), in 49 patients with the CG genotype (71.0%, n2 = 69), and in 8 patients with the CC genotype (42.1%, n3 = 19). After the statistical evaluation we have found the association between the dry eye syndrome and the GG genotype (chi2 = 8.9) and the association between less common dry eye syndrome appearance and the presence of the CC genotype (chi2 = 10.3). Severe dry eye syndrome we proved in 18 patients with GG genotype (51.4%, n1 = 35), in 31 patients with CG genotype (44.9%, n2 = 69), and in 4 patients with CC genotype CC (21.1%, n3 = 19). We proved statistically significant association between CC genotype and less often appearance of the severe dry eye syndrome (chi2 = 4.45). Corneal complications we noticed in one patient with GG genotype (2.8%, n1 = 35), in 5 patients with CG genotype (7.2%, n2 = 69), and in 3 patients with CC genotype (15.8%, n3 = 19). We did not prove statistically significant association between the 174 IL-6 polymorphism and corneal complications appearance. The 174 IL-6 polymorphism influences the appearance of the dry eye syndrome. In patients with GG genotype of the -174 gene polymorphism for IL-6 is its appearance more common. Patients with the rheumatoid arthritis and with CC genotype of the -174 gene IL-6 polymorphism have lower frequency of the dry eye syndrome presence.

Study: Autologous serum (again). Everybody listening?

This time from Czechoslovakia, but the message is the same and I hope all you MDs who have never tried serum are listening! Next time you have a patient who is still miserable with burning despite all your best efforts, please, consider taking the plunge.

[The application of the autologous serum eye drops results in significant improvement of the conjunctival status in patients with the dry eye syndrome]
Jirsová K, Hrdlicková E, Alfakih A, Juklová K, Filipec M, Faltus V, Veselá V.
Cesk Slov Oftalmol. 2008 Mar;64(2):52-6.

AIM: To detect the changes on the conjunctiva surface before and after the application of the autologous serum (AS) eye drops in patients with dry eye syndrome, using both clinical and laboratory approaches, supplemented with subjective assessing the discomfort status. MATERIALS AND METHODS: The AS eye drops were applied during the period of 3 months in 8 patients with dry eye syndrome (Schirmer test < 5 mm and break-up time < 5 seconds), with the highest (maximum) frequency 8 times a day. The clinical (Schirmer test, break-up time, rose Bengal staining, examination of the tear meniscus, detritus and superficial punctate keratitis) and laboratory examinations (morphological assessment of the conjunctiva, detection of apoptotic cells) were performed at the start and at the end of the 3 months treatment period. Each day, patients reported their ocular status (dryness, discomfort, foreign body sensation, light sensitivity). RESULTS: The AS eye drops application improved significantly the values of the Schirmer test, detritus and superficial punctate keratitis as well. The goblet cells density on the conjunctival surface increased and the number of apoptotic cells decreased. The intensity of unpleasant feelings reported by the patients decreased significantly in all of the assessed categories. CONCLUSION: Because the application of AS eye drops caused the improvement of conjunctival status as well as the decrease of the severity of difficulties reported by the patients, the AS eye drops application should become common therapeutic practice in patients with dry eye syndrome.

Study: Stevens-Johnson Syndrome.

Paints a grim picture. I'm puzzled as to why there is no mention of either bandage contacts or Boston sclerals. I'm not too knowledgeable about the former but the latter at least have well documented benefits for SJS. Why resort to surgery if you don't have to?

The ophthalmologic management of acute stevens-johnson syndrome.
Gregory DG.
Ocul Surf. 2008 Apr;6(2):87-95.

ABSTRACT Stevens-Johnson syndrome (SJS) and its more severe variant, toxic epidermal necrolysis (TEN), cause significant ocular surface damage. The majority of affected patients develop conjunctival inflammation during the acute phase of the disease. If intense, this inflammation yields permanent destruction of the normal mucosal tissue of the ocular surface and eyelids. Loss of the normal glandular structures leads to severe dry eye problems and vision loss. Medical treatments do little to arrest these problems, and repairing the damage after the acute phase is difficult, if not impossible. Recently, the application of cryopreserved amniotic membrane to the ocular surface during the acute phase of the disease has shown great promise in limiting the destructive inflammation and its long-term sequelae. A rationale for this treatment and a detailed description of the application procedure are provided, along with practical guidelines for the managing surgeon.

Newsblurb: AMO, tears and lasers

Weird. I don't see why a not-very-exciting not-really-new artificial tear forecast to do $12million in sales would even make the news for AMO much less be used to offset concerns about the outlook for refractive equipment. Whatever.

Analysts Look to FDA Lasik Panel Outcome

NEW YORK - Analysts said Monday Advanced Medical Optics Inc. is executing well on its new contact lens and dry eye product offerings, but expressed concern about the outcome of the Food and Drug Administration's panel meeting on Lasik surgery later this month.

Wachovia (nyse: WB - news - people ) Capital Markets LLC analyst Larry Biegelsen said Advanced Medical's launch of its Tecnis multifocal contact lens, Blink Tears dry eye treatment and iFS IntraLase laser upgrade will go a long way toward building investor confidence in the company's ability to execute.

In a note to clients, Biegelsen said Tecnis has the potential to be a significant contributor to the company's growth, given that it is Advanced Medical's initial foray into the largest market for implantable lenses. And with the lack of dry eye treatment options, he thinks his $12 million 2008 sales forecast for Blink Tears may be conservative. Finally, the iFS laser upgrade, which increases safety and precision of the device, will likely help fend off competition.