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Dr. Katherine MastrotaSECO is accepted as one of the best annual continuing education meetings for Optometry. This year’s program, as those in the past, brought excellent speakers to the podium.

As the American Board of Optometry prepares to administer its first examination to award Board Certification in Optometry, SECO responded by offering review courses to enhance test preparation.  Early morning coffee and donut sessions, lunch on the showroom floor, and industry- sponsored informational sessions insured that both the minds and the stomachs of attendees were fed.

 


SECO’s Marketplace hosted ophthalmic instrument manufactures, publication companies, and of course frame vendors.  Most exciting for me was to experience 3-D television.  Brilliant, high-resolution images emerged from the screen as I stood in amazement.  Of course I was wearing high-style, high-tech 3-D glasses that also function as sun wear.  These frames and lenses will be available to consumers as 3-D TV becomes a household “must have.”

“Buzz” about the diagnostic advantages of Fluramene was in the air—has anyone seen it on Twitter?  Who tweets?  Was anyone in the audience when Melton and Thomas (great OD educators) discussed Fluramene?

For all who have made Fluramene a part of their practice, please blog!  We would love to hear of your experience.

Word on the street is that Noble Vision is working on a special new dropper that would allow for smaller drops of Fluramene.  How great will that be?!

Please check back as I post on “What Bugs Me” about NaFl strip staining in dry eye patients…

Contact Dr. Mastrota

According to the Pharmaceutical Research and Manufacturers of America (PhRMA), American pharmaceutical research and biotechnology companies invested a record $65.3 billion last year in the research and development of new medicines and vaccines – an increase of more than $1.5 billion from 2008. At some point in their careers, many clinicians are presented with the opportunity to participate in, or even develop, clinical studies. As these studies become more complex in scope, rigor, and regulation, it is imperative that clinicians have a firm grasp on some undeniable risks of the clinical research process.

For example, be aware that a single site can negatively impact the results of an entire study, and variation in site performance increases with the number of cultures, languages and time zones involved. Moreover, variations in how treatments are administered and how data are recorded increase with the number, complexity and novelty of procedures performed at each site.

So, if these are the risks, how can they be mitigated?

  • Data Management: It seems obvious, but the importance of data management cannot be overstated. Data must be collected exactly as per the protocol, and the case report forms completed with the highest degree of accuracy. Study coordinators and other personnel involved in the trials must be properly trained on the metrics of the study, and the data should be submitted in a timely manner to the sponsor. Failure to resolve queries and delays in data submission increase the risk of poor quality data. Consider, perhaps, using a web-based data collection system if you’re designing a multi-center study. These systems can streamline data collection and assist with quality control.

 

  • Standardize Training of All Study Staff: The importance of this step increases with the complexity of the trial and what is being measured, as well as with the likeliness of subjective interpretation of the data collected. In my personal experience in designing and managing clinical trials in ophthalmology, I have seen entire data sets rendered worthless because individual study personnel at the same site performed the same tests in completely different ways. Obviously, the importance of this increases with the number of sites involved. Simply put, taking the time to train your study staff upfront may just save your study, ensure a valid outcome and increase the probability that your site will be invited to participate in additional research.

 

  • Keep it Simple: Well, if not simple, then at least as uncomplicated as possible. Consider the number of visits needed and try to keep them to a minimum. This will increase your patient retention and compliance rates, as well as keep costs down. Make sure your selection criteria capture the qualities most crucial to your trial’s success and make these criteria as clear and straightforward as possible.

 

  • Don’t Go it Alone: Consider hiring a Contract Research Organization (CRO). A good CRO can be worth its weight in gold. These organizations can assist with all aspects of trial design and management: protocol development, IRB submissions and other regulatory documents, case report form development, data entry and statistical analysis. Many of these organizations can also assist with site management, recruitment and medical writing. The size and complexity of these groups can vary greatly, from very small organizations to huge, multinational conglomerates, so it’s important to find what fit is right for you and your project. Also consider hiring a CRO with experience in your field, as this can dramatically reduce the learning curve.

 

  • Choose Your Study Sites Carefully: They can make or break your research. Look for experienced sites with dedicated study personnel and the capacity to do the specific project. This latter point is critical as not all sites are appropriate for all studies. Ensure that the potential site has the appropriate patient population and that these patients are available in sufficient numbers. Be cautious if one site’s results vary dramatically from findings at your other sites.

 

  • Use Adaptive Designs if Appropriate: Evaluate patient data periodically to determine if you’re asking the correct questions and getting the proper answers. Moreover, this may allow you to determine if your study is adequately powered. A perfect example of this is the trial by Merck that evaluated the Zostavax® vaccine for herpes zoster. Originally, the trial was based on a theoretical need for 440 evaluable cases of herpes zoster to show a 60% reduction in a patient self-assessment of pain with 97% power. After observing the first 200 cases, however, the investigators realized that the variability of the treatment effect was greater than anticipated and that the study would in fact require 750 evaluable cases. The sample size was increased to 37,200 patients to ensure the ability to gather the requisite number of cases. Costs increased, but the drug was successfully brought to market.

 

In conclusion, as the opportunities for involvement in clinical research continue to expand, many clinicians will be afforded new opportunities. By carefully planning your study and incorporating mechanisms to minimize risk, you maximize your potential for success.

Contact Melissa Earl

From now until March 24th 27th, 2011 Noble Vision Group will donate $1 to the relief efforts in Japan for every new follower on Twitter. For every retweet related to these efforts we will give $2.

Donation will be via Mercy Corps.

In the aftermath of nature’s recent merciless demonstration of power – the Japan earthquake and ensuing tsunami – there is chaos, fear, and the perpetual provision of more bad news. As we wait, watching and listening, hoping for signs  of progression towards recovery, we can join each other in making small sacrifices that when combined will make an exponentially larger impact.

Though we will max our donation at $1,000, we hope to find organizations, individuals, and companies that will match our success.  If you are interested in matching our donation, please contact Kate Malinoski at kmalinoski@noblevisiongroup.com.

To make your own donation, please visit Google Crisis Response.

If you are unable to make a monetary donation, let us do so on your behalf. Follow us on Twitter and help us spread the word!

Thank You Board

Total Raised: $110

New Followers: 62

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Retweets: 24

@stefanijenness, @aopchair, @eyesupplyusa, @jamieabe, @davidmshannon, @metrovisionoptic, @kstark29, @katieconnaghan, @izanator, @jordanmschenck, @kellamnelson, @doctorfidel, @huekahjohn, @fthemagazine, @emilyhutto, @nataliedube, @UOcareerPDX, @leighton_c, @jennacerruti, @j_rad, @shocktimus, @tescoOpticians, @rfid4dna, @dmarique, @djkoblenz,


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This Northern Goshawk, a fierce bird of prey suffering from eye deterioration, struggled to see its own food, let alone catch its prey. Ken Abrams, DVM (Veterinary Ophthalmology Services) and Paul Koch, MD (Koch Eye Associates) treat the eyes with an ophthalmic laser and in 20 minutes have repaired the bird’s vision in both eyes.

Contact Dr. Paul Koch

When Ophthalmologists receive the 2011 US Ophthalmic Review this March, they will be presented with a bold statement from senior researcher Robert S. Herrick, M.D..  A pioneer in the exciting new surgical specialty of Lacrimology, Dr. Herrick reviews how untreated Lacrimal System Dysfunction (LSD) increases parasympathetic tone, resulting in dysfunction in secondary body systems (one example includes the congestive respiratory diseases of both childhood and later life).  This may allow Ophthalmologists to uniquely act as primary care providers for both ophthalmic and non-ophthalmic conditions.  The authors go on to suggest that the National Eye Institute rename it’s “Classification of Dry Eye” to “Classification of Lacrimal System Dysfunction”, and that it be expanded to include lacrimal excretory hyperactivity and functional diagnostic tests (eg: temporary lacrimal occlusion with dissolvable plugs) to determine best treatment options.

Dr. Herrick is an Ophthalmologist / Lacrimologist practicing in Southern California.  As Director of the non-profit Herrick Research Foundation, contact Dr. Herrick at doctorherrick@gmail.com or by phone at (909) 205-5962.

Contact Kate Malinoski

Diagnosing and Delivering Lid Wiper Epitheliopathy in the Lane

Act One: The Conversation and Exam

In his article published in the prestigious journal, Cornea, in April 2010, Dr. Donald Korb revealed “lid wiper epitheliopathy” to be the identifiable seminal event and diagnostic hallmark of dry eye.  Additionally, in previous articles and lectures along with Dr. Jack Greiner and Dr. Caroline Blackie, he outlined the role of the Meibomian gland dysfunction in the process of symptomatic, as well as asymptomatic, dry eye.  Pharmacological correction of the resultant inflammation, as well as lid and tear support with appropriate lubricants, coupled with the restoration of Meibomian gland function to some form of normalcy is my current pathway to alleviating this most common malady.

For further understanding of the pathogenesis of lid wiper epitheliopathy, I refer you to Dr. Korb’s in depth article, “Prevalence of Lid Wiper Epitheliopathy in Subjects with Dry Eye Signs and Symptoms”.

“All the world’s a stage, and all the men and women merely players.”  For the day to day work in diagnosing and delivering lid wiper epitheliopathy in the lane, I visualize a two act play:

Act One: The Conversation and Exam

As I enter the exam lane and introduce myself, I grab a tissue and explain to the patient that I am going to put a drop into her eyes.  Noble Vision has combined Fluorescein Sodium and Lissamine Green into one drop (Fluramene).  I keep a bottle of Fluramene in my shirt pocket at all times for easy use during exams.  I reassure her that it will not sting.  I then ask the patient to look up as I pull her lower lid slightly down with my left thumb and gently squeeze the bottle with my right hand.

As I put the drop in, I ask the patient to gently close her eyes. I softly press the tissue against the closed eyes and dab to absorb any excess dye.  I now verbally inform the patient that she may have some slight staining of her lower lids, but the green coloring will easily wash right off.

Over the next few minutes I take the patient’s history.  By the time I have finished most of her history, it is time for the next drop.  I place the second drop, checking for staining and stippling.  I generally have a scribe, so the patient is hearing a description of her condition as I pull up and slightly invert the upper lid, turn on the blue filter for a closer look, and give my lid wiper grading and assessment.

I have found that the patient’s hearing of the terms and descriptions serves several purposes.

1.  It convinces the patient that a long process of assessment and work has been done in a short period of time.

2.  Talking about the patient’s lid parts and corneal surface creates a dialogue with the patient and this reflects that you care about her.

3.  While describing her condition, the patient will be hearing terminology that will be used in the explanation of her cause and the treatment process. “Mrs. Wetlittle has significant 3 plus staining of her upper cornea.  Her tear film break up is 4 seconds.  She has grade 3 lid wiper epitheliopathy.”

Now when you describe her condition back to her and your tech goes through her treatment regimen, she gets it!  This is an important step in getting the patient to be compliant with her therapy.

My final step is gland expression.  I tell the patient to keep her head touching the bar and her chin in the rest.  I then begin the expression process, described appropriately by Dr. Donald Korb as an art form.  It involves using my thumb and pushing the lower lid against the globe and watching the oily Meibomian secretions hopefully ooze out of the orifices.

I again describe for the patient and the scribe the result of the expression, in terms that the patient will understand and will eventually become part of her working vocabulary.  The patient hears terms like “six glands expressed with poor quality lipid oil”.   I have now set the stage for my patient to comprehend and become an owner of her Meibomian gland dysfunction. Every one of us has had a “dry eye” at one time or another, so if the only thing the patient hears is “you have a dry eye”, she has no true concept of her disease.

I think it is appropriate at this time to finish examining the rest of the eye if indicated.  I have now set the stage for my explanation of turning over the patient’s treatment regimen to my tech.

As we take a brief intermission, I hope you will stay tuned for Act Two: The Technician Describes the Patient’s Treatment Regimen.


Email Dr. McDonald

#1 Dr. Johnny Gayton Educates and Entertains with a Stand Out Presentation

For me the highlight of the meeting was a very insightful talk given by Dr. Johnny Gayton. He began by carefully outlining the key components of a successful Premium Cataract Surgery program – careful surgery; watching out for dry eye and how to treat it; watching out for CME and how to prevent it.

The key to the whole program is underpromising and overdelivering. That’s the key to patient success.

Then he pointed out that the companies do exactly the opposite and presented segments taken from the web sites of AMO, Alcon and B&L. In each case they promoted their premium lenses and giving the patient a “full range of vision,” from “distance to intermediate to near.” No matter how you read their web sites, the result was the same. Each company was overpromising (and routinely underdelivering), while admonishing us to do exactly the opposite.

I don’t have to tell you he had us laughing so hard I had tears in my eyes.  What an insightful talk into the strong sales tactics of the three companies, leaving us to counsel the patients that what they read on the web site isn’t the truth at all; and then have the patient wonder why we don’t deliver what the companies promised them.


#2 In Defense of Cataract Surgery

I’m getting a little tired of people – sales representatives, administrators, surgeons, talking down cataract surgery. Cataract surgery is the most successful operation ever devised, with the most significant impact on the human race.  Why then, in an attempt to sell premium lens upgrades I keep hearing people suggest saying, “You don’t want the standard operation, do you?” and “You don’t want the government-issued IOL, do you?” or “You’ll have to sign this disclaimer if you decided to have the standard operation because I won’t be held responsible,” or some such malarkey.

If someone said to me, “You don’t want the standard operation, do you?” I would reply, “Dang tootin’ I do! I want that great operation all my friends had. Don’t give me some non-standard one. I’m no guinea pig!”  Why wouldn’t I want an operation performed 3 million times each year with overwhelming success and a litany of incredibly happy patients?

If someone asked me if I wanted a “government-issued IOL” I would say, “What are you talking about? That doesn’t apply to me. I’m a civilian. I have Blue Cross.”

The solution is not to denigrate “standard” cataract surgery but to make a compelling reason why a premium lens is better. It’s coming up with a compelling reason why buying a premium lens is worth so much more than the pretty darned excellent operation they would get otherwise.


#3 A Clever Solution to an IOL Obstacle

This was pretty cool. There are still surgeons who do not like to use IOLs with rings – the multifocal IOLs – and prefer the monofocal/accommodating lens, the Crystalens. The problem is that lens does not usually kick in for good near vision. One model does, the HD, but the tradeoff is that the distance vision isn’t as good, and it’s harder to hit target emmetropia.

Two speakers at this meeting showed results of putting a Crystalens AO in the dominant eye and the Crystalens HD in the non-dominant eye. That gave the patient two monofocal lenses, both accommodating, with the AO giving clearer vision for distance and the HD giving better reading vision.

It’s a pretty good idea and I bet others are going to give it a try.


#4 All Those Expensive Eyedrops…Is Anyone Using Them?

I hosted an open discussion called, “All those expensive eyedrops, is anyone using them?” I’m happy to say it was fairly well received because just about everyone is in the same boat. A year ago we had a win-win-win with us prescribing the antibiotic of our choice; the patient buying one medication; the pharmaceutical company making enough off that one drops to be able to give the patient the steroid and the non-steroid, so the patient got three for the price of one.

Then the feds took umbrage, feeling that this program was an illegal inducement to use a particular product, so the programs went away. More recently things got worse when pharmaceutical company support for cataract surgery and ASCs disappeared after the feds decided to crack down on off-label promotions.

The problem we have is that it is impossible to test an antibiotic for prophylaxis for cataract surgery, so they are tested and approved for conjunctivitis. We find the ones with the best activity and penetration and we use them in the peri-operative period to prevent endophthalmitis. This is, of course, a necessary but off-label use of the antibiotic.

Last year the feds leveled a $600 million fine against Allergan for off-label promoting of Botox and so now all the companies are running scared of another penalty, so to avoid the appearance of promoting off-label use of antibiotics they’ve stopped providing samples or assistance for our surgery patients altogether.

So within a year our patients have gone from buy one get three; to having to buy all three but with samples available to help those with financial problems; to having to buy all three but not having any samples available even for poor patients.

Yes, one more example of how our government is helping us every day.


#5 How to be Sure You’ve Identified the Toric Axis Accurately

Marc Michaelson had a great presentation about intraoperative axis placement of a toric IOL. We’re been vexed trying to find the best way of marking the eye, or photographing the eye, or somehow finding a way to be sure we’ve identified the toric axis accurately.

Marc uses an old Maloney qualitative keratometer that cost him a few hundred dollars many years ago. During surgery he uses it to identify the steep axis and make a mark. Bingo, he’s done. No need to photograph the eye prior to surgery, or to mark the eye in the pre-op area, or to try to compensate for cyclorotation in the operating room because he’s measuring the axis right on the table. It’s a very cool and very inexpensive solution to a persistent problem.

The Maloney keratometer is also pretty good for determining the success of your LRIs, too.

Email Dr. Paul Koch

As an eye and facial plastic surgeon, one of the most common questions patients ask me is “is it covered by insurance?” Well, the answer isn’t always a simple one. Plastic surgery is a field that involves functional, reconstructive, and aesthetic surgery. Patients often confuse the term “plastic surgery” with “cosmetic surgery” and as physicians we know that these are not the same. Lifting a severely drooping eyelid (ptosis) so a patient can achieve useful vision from an eye is certainly plastic surgery, but not cosmetic. Getting rid of those unwanted bags under the eyes is also plastic surgery, but is cosmetic.

The difference is all about function.

When it comes to eyelid plastic surgery, function is very important. The eyelids are responsible for protection of the eye and maintenance and drainage of the tear film. Drooping upper eyelids block vision, hanging lower eyelids cause tearing and irritation, and retracted eyelids cause exposure problems to the ocular surface.

The eyelids and brow are also critically important to facial aesthetics. So where is the “line in the sand” for a patient’s surgery to be functional as opposed to aesthetic? Each insurance carrier has different guidelines, but a good rule of thumb is: if the patient is doing the surgery because they don’t like they way something looks, it is cosmetic. This does not hold up 100% of the time, as some scar revision and craniofacial reconstruction can be a covered benefit, but it is a good place to start.

In order for Medicare, for example, to cover a blepharoplasty or upper eyelid ptosis repair, three things are required: The patient must have a complaint (eyelid is interfering with vision), external photography must document a certain amount of ptosis or dermatochalasis (hanging eyelid skin), and visual field testing must indicate a superior visual field obstruction which resolves with taping of the eyelid.

Brow lifting surgery is less likely to be functional. If a patient’s eyebrows are actually near or below their eyelashes, then brow lifting surgery can be a covered benefit if the above criteria are met.  Forehead lifting (endoscopic or direct) is generally considered to be cosmetic surgery, though there is some potential functional improvement, as well.

For example, an endoscopic forehead lift uses small incisions behind the hairline, and fiberoptic technology. This procedure allows elevation of the eyebrows, entire forehead, and improves “crowsfeet” and frown lines. The scars from this procedure are hidden behind the hairline. A direct brow lift uses incisions just over the eyebrow, and lifts the brow up and away from the visual axis. So even though both procedures address the potential visual obstruction caused by brow ptosis, the main purpose of the endoscopic procedure is cosmetic, and the direct approach is generally reserved for visually obstructive brow ptosis in patients who don’t mind a potentially visible scar.

For individual and detailed regulations on coverage of procedures or services for your patients, please contact the insurance provider.

Email Dr. Black


Starting February 9th, I’ll be leading three webinars on Herpetic eye disease, the leading cause of corneal blindness in the Industrial world.In light of new advancements in the area of herpetic ocular disease management, this webinar will discuss the various presentations of herpetic keratitis from the classic dendritic keratitis to the often misdiagnosed endotheliitis.

It will discuss and explain various presentations of this viral disease that has been known to masquerade various ocular diseases.   New developments in treatment modalities including the first topical antiviral in the US in 30 years, ganciclovir (Zirgan) and valacylovir (Valtex) going generic have changed how clinicians manage herpetic keratitis.  Come learn the latest developments in diagnosis and management of herpetic eye disease.The times for the webinar are as follows:

Wednesday, February 16th at 10pm (EST)

Wednesday, February 23 at 8pm (EST)

CLICK HERE FOR REGISTRATION AND MORE INFORMATION!

Email Dr. Karpecki


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