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Lipiflow and the Research

What does Lipiflow treat?

Lipiflow is the only FDA approved treatment for Meibomian Gland Dysfunction (MGD).  This condition is responsible for most causes of dry eyes.   The Meibomian gland is found in the eyelids adjacent to the eyeball itself. It is the most common cause of Dry Eye Disease.  If left untreated it may cause scarring on the eyelids or cornea, redness, tearing, burning, itching and even permanent vision problems.   Additionally, the meibomian gland will shrink resulting in more dryness that can be permanent.  The glands will eventually be lost to shrinkage and inflammation.  The body does not have the ability to regenerate these glands, nor will the grow back.  It is best treated early, because we can not grow the glands, but may be treated anytime the diagnosis is made, even if symptoms haven't yet begun. Similar to hypertension and diabetes, damage occurs before the disease becomes symptomatic.   The treatment is geared towards opening the clogged meibomian (oil) glands.   This is done most effectively with a state of the art machine in our office during a 12 minute  painless and easy treatment. The treatment is called LipiFLow and is completely pain-free.   A small device is placed on the eyelids and safely heats the clogged oil glands while gentle pulsations expel the melted material.  The following studies from the medical literature support the effectiveness and safety of this valuable treatment.

Can hot compresses do the same as Lipiflow?


The Limitation of Applying Heat to the External Lid Surface: A Case of Recalcitrant Meibomian Gland Dysfunction.


Case Rep Ophthalmol. 2017 Jan 16;8(1):7-12. doi: 10.1159/000455087. eCollection 2017 Jan-Apr.

Kenrick CJ1, Alloo SS1
Purpose- To compare four commercially available heat therapies for recalcitrant meibomian gland dysfunction.

Conclusion- Given that the anatomic position of the meibomian glands is adjacent to the palpebral conjunctiva, and therefore closer to the inner eyelid surface than the outer surface, it is reasonable to expect that application of heat to the inner eyelid surface would be more effective in increasing the temperature of the glands. Thus, it is not surprising that LipiFlow was the only therapy which elevated the temperature above the target value...The potential problem of heating the inner eyelid surface without raising the temperature of the cornea is achieved by the LipiFlow activators in a unidirectional heating surface that simultaneously insulates the ocular surface. 


Layman's Interpretation:  Of 4 products which apply heat to the eyelids, only LipiFlow achieves the...temperature needed to melt the material clogging the meibomian glands.  This is because LipiFlow is the only product which applies heat to the inner surface of the eyelids.  Lipiflow will achieve a temperature of 108.5 degrees.  A cornea shield will protect the cornea preventing burns.  When applying heat to the external lid it is quickly dissipated and the glands do not get the desired temperature to melt the oils.   Using a higher temperature hot compress may cause a thermal burn to the lids, cornea and glands themselves. Lipiflow is the preferred method to treat MGD.

How long will it last? Is it safe?

   


A new system, the LipiFlow, for the treatment of meibomian gland dysfunction.

Cornea. 2012 Apr;31(4):396-404. doi: 10.1097/ICO.0b013e318239aaea.


Lane SS1, DuBiner HB, Epstein RJ, Ernest PH, Greiner JV, Hardten DR, Holland EJ, Lemp MA, McDonald JE 2nd, Silbert DI, Blackie CA, Stevens CA, Bedi R

Purpose- To evaluate the effect of a single treatment with the LipiFlow Thermal Pulsation System on signs of meibomian gland dysfunction (MGD) and dry eye symptoms over a 9-month period.

Conclusion- With such prolonged improvement in signs and symptoms of dry eye disease, the LipiFlow Thermal Pulsation System offers a technological advancement for the treatment of dry eye disease secondary to meibomian gland dysfunction. A single 12-minute LipiFlow treatment results in up to 9 months of sustained improvement of meibomian gland function, tear break-up time and dry eye symptoms that are unparalleled with current dry eye treatments.


Layman's Interpretation: LipiFlow is more effective than other heat application systems.  LipiFlow is safe.  There were no adverse effects on vision, eye pressure, or any aspect of ocular health.  In our practice, we will provide our patients an effective treatment plan that will typically make the Lipiflow treatment last 2 years. This is something we have not ever been able to accomplish in the past and has helped most every one of our patient's

How does it compare to other treatments? Will it help my lifestyle?



Meibomian gland dysfunction: a comparative study of modern treatments

J Fr Ophtalmol. 2014 Apr;37(4):303-12. doi: 10.1016/j.jfo.2013.12.007. Epub 2014 Mar 20.



Baumann A1, Cochener B2.
Purpose- To evaluate a thermal pulsation treatment compared to a warming eyelid device for the management of meibomian gland dysfunction.
Conclusion- The combination of heat applied to the inner eyelid surface, together with simultaneous expression of the glands, during a single 12-minute treatment shows to be highly effective in treating cases of meibomian gland disease. Whilst results were excellent, and continued lid hygiene remains advised, the benefit of being able to simultaneous address potential compliance issues relating to ongoing treatment is significant. The convenience of a single 12-minute treatment versus an ongoing daily heating regime was shown to be highly desirable and a welcome relief in our patients' busy lifestyles.
Layman's Interpretation:  LipiFlow provides a faster improvement than twice daily compresses and the 12 minute treatment is more convenient than ongoing twice daily compresses for patients with busy lifestyles.  In our experience, most patient's are unable to do hot compresses effectively.  Patient's have also burned their skin.  Many whom work regular jobs can't commit to the time required to do them.  The combination of all these factors makes Lipiflow the treatment of choice.  

How do I know if I'm a candidate?

Prior to having the Lipiflow procedure, and inflammatory test will be performed. Photographic and Infrared imaging will be taken to determine the health and gland loss you currently have.  Tear assessments will be performed by multiple modalities.  We only suggest Lipiflow to patient's that need it and will have a good outcome.  Most patients are candidates that have MGD.  

What level of success do you have?

In our experience, which is enormous, we have found that Lipiflow helps most all patients.  The exact percentage is about 98%.  Essentially, we see all of our patient's oil production significantly improve.   While the quality of the oil is almost always significantly improved, the quantity of tears may not be enough if the gland loss is too much.  In this case, we have other treatment's that will help virtually all of our patient's.  Additionally, the regimen used after Lipiflow is not the same with all doctors.  We have found our regimen to have the best outcomes.

Lipiflow and the Research

Words from the Medical Director

Everyday I see patients with dry eyes.  Some of their symptoms include tearing, feeling of wetness around the eyes, scratchiness, tired feeling eyes, burning, itching and irritation.  The first step is testing.  It is most important to determine if there is an inflammatory or autoimmune cause of dryness. We then look at three layers of your tears including mucous, water and oil layers.  After that we do high resolution photography of the glands and infrared photos.  This helps us put together the complete picture.   In the picture seen here, you can see what looks like small whiteheads.  Each of these are glands that are blocked.  This is a from a young patient.


From here, we have about 20 different treatments for your dryness. One of which is Lipiflow when the oil (meibomian) glands are blocked.  I've heard from other physicians they are not having 100 percent success with this treatment.  The answer is picking whom to treat.  If you are missing all your glands, there is nothing to fix.  These patients will not benefit from treatment in most all cases.  What I also see often is patients that have had symptoms for years or more, and then on the photography the glands are mostly all dead and missing.  


Its important to know that all patients start with just basic symptoms like dryness on the computer, or sticking of the lids when asleep and upon waking up, or dryness of the contacts during the day. All of this is just the beginning.  This is when you should be seen to rule out all the possible causes of dry eyes, especially, autoimmune forms.  Patient's ask me but why...I'm only mildly symptomatic. The answer is but that's now, because when you get worse its because you lost a lot of function of the glands and when they're gone they're gone.  I can't get the back.


All patients no matter how much computer use you have should be able to keep their eyes moist throughout the day. If they're getting dry with computer use get them checked.  Delay only leads to worsening and its so easy to do the testing there is not reason to delay.


We also see a lot of children and young adults with severe gland loss from chronic computer use, or overuse.   In the past mom's would ask me if computer or tv use in excess will harms my child's eyes..and in the past we all used to say no and that's an old wives' tale..  Now, we've learned a bit from dry eyes and it turns out that overuse of the computer or tv leads to poorly functioning meibomian glands and loss of these glands.  More than ever, we are seeing young adults come in with mild, moderate and severe gland loss.  These glands are not fixable, replaceable or repairable. Loss is permanent.  


Today, dry eye testing is so easy and mostly covered by insurance that everyone would benefit from testing, especially young adults.


If your child is an avid computer, cell phone or tv user, come in for dry eye testing and lets check those glands to make sure they're functioning well and there is nothing serious.  



Real Testimonials

"Prior to having the Lipiflow procedure, I felt my eyes everyday.  Most nights, my lids stuck together when I woke up and I was in pain often.  I felt fatigue daily.  Afterwards, I was about 50 percent better in 3 weeks and in 2 months 80%.  Its not perfect but I am so much better, and with all the gland loss my doctor was happy I came this far.  Super happy here"


"I saw Dr. Wallshein for dry eyes that several other practices in the area treated with artificial tears and ointments at night.  I had scratchiness so much that I couldn't work.  I've had Lipiflow and Autologous Serum and my life is great again."


"I went to Dr. Barish with mild complaints of dryness and occassional tearing.  I saw my glands on the imaging and they looked horrible. I can't believe my other doctors missed this.  Today, I feel pretty good and Dr. Barish says I'm getting much better.  I definitely feel like it worked well and I'm glad to be followed regularly by such a competent and well versed physician"


"Life was pretty bad for me and there was no light in sight.  I can see great now and my comfort is 100%.  Lipiflow isn't covered by insurance but well worth it."

Frequently Asked Questions (FAQ's)

How long will it work for?


The exact answer is about 1-3 years.  Depending on how much gland loss you have and if you follow the regimen given to you.  If you follow the regimen closely, it will work for about 2-3 years


Can I drive there and back?


Yes, it will cause no harm to you or change your vision.


Is there any pain?


None at all.  Some people get anxious with the device on the lids but we'll give you some nice relaxing music and a comfortable chair for the 12 short minutes.


What's the cost?  


The price is $950 dollars for both eyes.  If you do one eye its $600. 


Will I need anything else?


The doctor will tailor a program for you on your exam.  Most patients will need some drops to take that will be reviewed on your exam date


Can it be repeated?


Yes.  There is no limit to the number of times.


What are the side effects or risks of the procedure?


None.  


How  long until the maximum achieved outcome?


We find that most patients will be significantly better in 3 weeks.  Many are better by the next day. Some take 4 months to get full improvement.  Its based on the number of glands and how many are fully functional.  The more glands and more active they are the faster the results.


What if I do nothing?


Doing nothing is not an option for MGD.  It will result in gland loss and worse problems down the line.


What percent of patients have MGD versus other forms of dry eyes?


In our experience 80% of all dry eyes is MGD.  We do have a lot of just about every form and many patients have multiple causes, not just MGD but MGD and something else when it is MGD.

Meibomian Glands and MGD

Normal Lid Anatomy

Here you can see the Meibomian gland.  Note that this is an upper eye lid.  The gland is closest to the eyeball and furthest from the external skin.  As a result of this position, when applying hot compresses the heat must transfer a long distance to get to the gland.  In that process, a lot of heat is lost making hot compresses poorly effective in the treatment of MGD

Meibomian Glands Infrared Image

This picture is of the meibomian glands on infrared imaging.  Notice that the glands look like long stringy pasta.  They are seen going from the top to the bottom of the lid.  You should be able to count about 25 in a lower eyelid in the normal person.  Also notice that they are very bright white on infrared images, there is a small space between all of them, and they are all approximately the same length, width and there are no bifurcations.

Moderate Gland Loss

In this picture, note that there is missing glands in the center of the picture.  Short glands in the right of the picture, and bifurcated glands on the left.  Also notice that the glands are not bright as compared to the previous image.   This is a patient that has moderate gland loss and because the glands are not bright on the imaging, we typically see these glands shrink or die in the future unless treated.

Severe Gland Loss

In comparison to the previous two images, you can see severe gland loss in this one.  On the left side of the lid there is almost no glands remaining.   In the middle and right there is a small residual amount of glandular tissue.  This patient would is in danger of complete gland loss and high risk for infections and vision loss.

The Lipiflow Procedure

Here is a picture of a patient having the Lipiflow procedure.  The device on her left eye is the same one all patient's would have.  It rests on the eye and is comfortable.  The total procedure time is 12 minutes.

Anatomy of the Tear Layer

The human tear is composed of 3 layers with the lipid layer being the outermost.  It is the most important layer in terms of providing comfort to the patient.  It is also created by glands that never regenerate and do not grow.   When we test for dry eyes, we will evaluate all 3 layers and provide results for you.