What Is Meibomian Gland Dysfunction and What Role Does It Play In Dry Eye?
The term “meibomian gland dysfunction” (MGD) was first introduced by Drs. James McCulley and George Sciallis in 1977, and again by Drs. Donald Korb and Antonio Henriquez in 1980, but gained national attention in the last decade thanks to TearScience’s line of medical equipment that allows eye care professionals to actively and systematically assess gland function, image glands, and treat MGD using LipiScan®, LipiView® II, Meibomian Gland Evaluator (MGE), and LipiFlow®.
The International Workshop on Meibomian Gland Dysfunction (MGD) defines MGD as “a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease.”2 It’s also important to note that MGD is both chronic and progressive in nature.
Meibomian glands are a sebaceous gland that contains a grape-like cluster of individual acini that secrete the oil product meibum, which includes lipids and proteins. Understanding the lipid pattern and composition is conceivably the next phase of research needed to discern meibomian gland dysfunction and a critical piece in testing for non-obvious meibomian gland dysfunction and early treatment. Meibomian glands are holocrine glands, meaning the cell is destroyed and excretions include dead cell fragments. Because the acini cells are constantly having to regenerate, discovering what inhibits this regeneration is vital to understanding meibomian gland dysfunction. While the upper lid (25-40) has more meibomian glands than the lower lid (20-30); their relative functional contribution has yet to be determined.3
Risk Factors:
- Demographics: geriatrics, women, Asian
- Systemic conditions: Lupus, RA, Sjögren’s syndrome, etc
- Medications
- Environmental
- Ophthalmic Surgery
MGD is a multifactorial condition with many causes contributing to atrophy and changes secondary to gland obstruction. Not all the causes are fully understood and more are being hypothesized and researched. We do know that older patients, women, and patients of East Asian descent may be at greater risk for meibomian gland dysfunction.3
Hormonal changes also affect the meibomian gland production as the nerves are affected by androgens, estrogens, and growth factors. Inflammatory systemic conditions like Rosacea, Rheumatoid Arthritis (RA), Lupus, and Sjögren’s syndrome have been linked with MGD. Some medications, such as Accutane and topical glaucoma medications, have been associated with gland changes and atrophy.3 Environmental factors are linked to meibomian gland dysfunction, especially the misuse of eyeliner and make-up. Other environmental factors include long duration of screen use or high cognitive demand tasks and consequently decreased or incomplete blinking. There are some studies that show extended or daily wear, non-daily-disposable, contact lenses are linked to meibomian gland atrophy.12 More research is needed to assess to what extent if contact lens wearers are at increased risk for meibomian gland dysfunction. Iatrogenic dry eye after ophthalmic surgeries have been linked to meibomian gland dysfunction as well. The following figure nicely sums up the multifactorial causes and processes of meibomian gland dysfunction.
Signs & Symptoms of Meibomian Gland Dysfunction:
While the symptoms of meibomian gland dysfunction are similar amongst many dry eye patients; redness, dryness, burning, grittiness, intermittent blurry vision, and foreign body sensation, the signs are where we can differentiate and diagnose MGD from other causes of dry eye syndrome. In one study, research from Lemp et al9 showed that as many as 86% of patients with dry eyes have MGD, while another study by Korb and Blackie showed that as many as 39% of asymptomatic patients had MGD!4
What Is TearScience?
TearScience was founded in 2005 by Dr. Donald Korb and Tim Willis as a medical device manufacturer committed to providing solutions for eye care professionals (ECPs) to treat meibomian gland dysfunction and evaluate meibomian gland health. In 2009, the LipiView® system was launched and in 2011 the LipiFlow® system was launched.
LipiView® functions to capture lipid layer thickness and blink analysis, and LipiFlow® provides treatment for evaporative dry eye by liquefying and evacuating meibomian gland obstructions. LipiView® II was introduced by TearScience in 2014, which provided high definition structural meibomian gland images by utilizing reflected and transilluminated light sources. In 2016, TearScience released a high-definition gland imager called LipiScan®, which allows ECPs to assess meibomian gland structure in a practice setting.
In 2017, TearScience was acquired by Johnson & Johnson Surgical Vision, Inc., joining their growing portfolio of consumer eye health products and services to help them fulfill their commitment to improving and restoring sight for patients worldwide.
How to Evaluate Meibomian Gland Dysfunction By Assessing Structure and Function
The Johnson & Johnson Vision portfolio of products, including LipiScan® and LipiView® II, provides the tools needed to assess structure via meibography. The physician, with the aid of a slit lamp, can grossly check using a transilluminator, but it is helpful for patient education to be able to photographically show patients their glands in high definition. Gland atrophy can be present in the absence of symptoms. LipiScan® and LipiView® II use Dynamic Meibomian Imaging™ (DMI) to provide fast, high-definition images of the meibomian glands with both transillumination and surface illumination images of the meibomian glands.
You can get an image of both lower lids in about 60s with a trained technician using LipiScan®. I only tell my technicians to evaluate the upper glands with lid eversion if there is significant atrophy of the lower lid meibomian glands. By teaching your technicians lid eversion with a cotton tip applicator, they can easily capture both upper and lower lids when needed. With patients in the chair, I start by showing them the meibomian gland atrophy progression chart (Image 1), point to the top, and say “We are looking to assess meibomian gland structural compromise.” I then show them where they fall on the scale from normal to severe. For recording, I will count the number of complete gland atrophy in each eye, as well as estimate the amount of truncation in four categories (0-25%, 25-50%, 50-75%, >75% truncation). I will also note any significant tortuosity or fracturing (gland atrophy in the middle of the gland, which, overall, is less common). It is also important to note any atrophy, which could have been a result from a hordeolum or surgery.
Image 1: Transilluminated View of Meibomian Gland Structural Changes
Assessing Meibomian Gland function:
The two objective clinical tests I always do are Tear Break-Up Time (TBUT) to assess tear film homeostasis and the Meibomian Gland Evaluator™ (MGE) to assess gland function. I usually have the patients back one month after a comprehensive exam to perform these two tests. During the comprehensive exam, I am using more pressure to assess the quality of the meibum on a scale of clear and flowing (0) to opaque and obstructed (4): does it most closely resemble fresh olive oil, thickened/cloudy inspissated oil, honey, or toothpaste? There may also be no secretion at all. During the follow-up visit we will then perform MGE and count how many glands are functioning with normal blink pressure.
Image 2: Clear oil upon expression
Image 3: No oil on expression
MGE applies between 0.8 g/mm2 and 1.2 g/mm2 and mimics the pressure of a deliberate blink.13 The blinking mechanism is the functioning process of how the meibum is secreted. Through pressure and capillary forces, when the eyelids touch and then open, meibum is pulled and expressed from the lid margin orifice. This is why blinking exercises and evaluating the blinking frequency and completeness is crucial. You can evaluate blinking by observation with NaFL right after checking TBUT or with the advanced imaging techniques with LipiView® II which shows you (and the patient) any partial blinking as well as a percentage of partial blinks.11 You can further access the thickness and quality of the meibum lipid layer using LipiView® II.
How Does LipiFlow® Work?
Efficient treatment for MGD has unfortunately been lacking for decades. The traditional warm compress (which for most patients is a warm washcloth, and is even further from effective treatment) was holding back the medical image of optometry. On top of this, patients instructed to use warm compresses are the clearest examples of poor patient compliance. Warm compresses can easily be equated to flossing in that every meibomian gland dysfunction patient should be using them on a regular basis, but few, if any, do. While the original method of individual manual gland expression, with a paddle or equivalent tool, might also work, it can be extremely uncomfortable for the patient, and difficult for the doctor to execute, greatly limiting its repeatability when it comes to treatment. The fact that meibum re-solidifies in about 30 seconds after liquefaction shows why the procedure can be painful and ineffective. Lastly, manual expression is time consuming and very difficult to perform on the upper lids due to anatomy. Thanks to recent research, revolutionary optometrists like Dr. Donald Korb and Dr. Caroline Blackie, and the FDA clearance of LipiFlow® Vectored Thermal Pulsation treatment in 2011, we finally have a way to efficiently and comfortably treat MGD blockage of both upper and lower eyelids simultaneously! This provides us not only a means to treat symptomatic patients, but proactively identify blocked and atrophied glands in patients who might not yet be symptomatic using LipiScan®, LipiView® II, and the MGE tool.
LipiFlow® is a 12-minute*, in-office, drug-free mechanism of action, automated procedure for the treatment of meibomian gland dysfunction. The automated procedure reduces doctor time to just lid preparation and application of the Activators, while treating all glands, not just ones that can be observed during examination. The device has a small footprint and can easily be moved and stored when not in use. The device uses highly advanced, single-use, sterile Activators that are placed on the patient’s eyes by the doctor and are controlled by the console. Prior to treatment, we recommend an initial numbing drop to improve comfort. LipiFlow® is supported by more than 31 U.S. patents and used around the world as a first line treatment for meibomian gland dysfunction. * Excludes setup time.
LipiFlow® applies just the right amount of heat and pressure to be both safe and effective. LipiFlow®‘s heating element is what makes it stand apart from its competitors. The heat is applied to the inner palpebral conjunctiva, which is closest to the tarsal plate and the home of the meibomian glands, while also insulating the cornea. One of the reasons warm compresses or external heating devices are not effective at getting blocked glands functioning is due to this difference in heat application. External heat has to penetrate through adipose tissue and the orbicularis muscle before reaching the tarsal plate and the meibomian glands.
The device regulates the amount of heat applied and has multiple safeguards that prevent the temperature from exceeding 44 degrees Celsius at the inner eyelid surface. The insulation barrier of the lid warmer limits the maximum temperature at the corneal side of the lid warmer to less than 40 degrees Celsius. This allows to reach the meibum melting point and liquefy it for easy movement. Redundant sensors constantly monitor and control the heat being applied, which is monumental for LipiFlow®’s excellent safety profile and no serious adverse events in pivotal trials.14
LipiFlow® uses pulsed sequences of air to fill the bladders on the upper and lower part of the Activator to express the meibum and stagnant debris in the glands of both eyelids in order to unblock gland orifices. The pressure is constantly monitored to ensure safe levels with an intelligent pressure feedback loop between pressure sensors in the Activators and console. The pressure is applied in a peristaltic, proximal to distal, motion to essentially milk glands, similar to how your esophagus works to safely move a bolus of food from your mouth to your stomach.
A study performed by Dr. Caroline Blackie, et al was designed to determine the sustained effectiveness of a single LipiFlow® procedure and compare it to twice-daily warm compresses through three months (control group). The scientifically validated OSDI questionnaire was used as a subjective measure of improvement and the MGE was used to determine function with a total meibomian gland secretion (MGS) score ranging from 0 to 45, with a score of 45 indicating clear liquid from the 15 lower lid glands evaluated.
With a single LipiFlow® procedure and no other dry eye treatments, there was a statistically significant improvement in both signs and symptoms. OSDI scores dropped (improved) from 44.1 to 21.6 from baseline through 12 months. Also, the MGS score jumped from 6.4 to 17.7 at one month and then was maintained through 12 months. The control group did have some improvement in MGS over 3 months but then reciprocated the LipiFlow® results after LipiFlow® was performed after 3 months of control therapy (crossover treatment group). Symptoms were controlled with a single LipiFlow® procedure in 86% of patients and 89% of crossover patients.
Figure 2: Mean MGS score over time for the 12-month cohort of eyes that received a single Vectored Thermal Pulsation™ treatment.
A newer study published in 2016 showed that there was significant treatment effects from a single LipiFlow® procedure three years after the treatment.6
For those with stubborn dry-eye symptoms after PRK or LASIK, a LipiFlow® procedure improved SPEED II patient questionnaire scores significantly. Using a different method of assessing function, the study also noted improved TBUT (+1.9 seconds), and reduced (better) MGD score and corneal staining.8 (Note: Do not use the LipiFlow® System in patients who have had ocular refractive surgery within prior 3 months)
It should also be noted that the duration and severity of MGD affected the prognosis and outcome of the LipiFlow® procedure, with better results found in those that received earlier treatment or had less severe meibomian gland dysfunction at the time of the LipiFlow® procedure. For these reasons, LipiFlow® is an excellent first line treatment for offices that are proactive in their approach to dry eye care.
Interested In Learning More About Bringing LipiFlow, LipiScan, or LipiView to Your Practice?
We have a direct partnership with Johnson & Johnson Surgical Vision!
Real Cases of LipiFlow® in My Practice
Note: Refer back to Image 1 for normative gland structure.
Case 1: MT
MT is a 48 YOWF that presented to my office for a routine exam. Her secondary complaints revealed epiphora first thing in the morning that sometimes took hours to go away. She tried Refresh Tears™ but didn’t feel like they helped. She stated that her eyes didn’t feel dry, but they had some itch in the morning and afternoon. My exam revealed the following significant findings:
- Epiphora OD>OS
- Good punctal apposition
- Grade 2 Meibum
- Gland engorgement and atrophy
We started daily warm compresses with EyeEco D.E.R.M™ and EZ Tears™ (Omega-3). We discussed LipiFlow® at this visit but had her back for further evaluation since we were accomplishing a routine exam during the initial visit. The follow-up visit revealed:
- (-) Jones Test OU
- MGE: 2-3 glands open OU
- LipiScan® Images (below)
Based on the gland atrophy, truncation, engorgement (i.e structure), patient symptoms, reduced meibum quality, and very low MGE score (function), we determined that LipiFlow® would be the best treatment for her, and she then proceeded with an uneventful procedure.
At our six to eight week LipiFlow® follow-up visit, MT could not have been more happy and her eyes were feeling great. MGE revealed 50-60% of glands were expressing OU (13-15 glands)! She was compliant with the Omega-3 supplements, was doing blinking exercises on occasion, and didn’t feel she needed any artificial tears. We treated some residual allergies and itch with Pazeo® QD PRN and she was on her way. At her yearly exam, MT was still feeling great and had none of her previous symptoms. Below is a testimonial she gave to us after having LipiFlow® done.
“The LipiFlow® has brought immense relief. I no longer feel the burning, and the watering has decreased significantly . It is so nice to not be constantly thinking about my eyes! Thank you for the relief!” – Eyes For Life LipiFlow® patient MT
Treatment Summary:
| Pre-LipiFlow® Treatment | Post-LipiFlow® Treatment |
|---|---|
| 2-3 MGE OU | 13-15 MGE OU |
Case 2
POTENTIAL ADVERSE EFFECTS for the LipiFlow® System: Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in:
- Eyelid/eye pain requiring discontinuation of the treatment procedure;
- Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion);
- Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)); and
- Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).
SC came to my office for a routine exam with complaints of near vision blur. She is a 51 YOWF who had LASIK in 1999 and then an enhancement in 2002. She stated she has learned to deal with her dry eyes because it has been so long standing. She complained that her eyes were always bloodshot. She had tried punctal plugs 10+ years ago without improvement, and had them removed before our examination. She was taking an SSRI, folic acid, and some vitamins.
On initial examination she had grade 1 meibum through some glands, but the majority of them were non-secreting with thumb pressure. She also had telangiectasia along the lid margins. Her corneas had well-healed LASIK scars. Images taken via LipiScan® can be seen below:
Image 6: Right Eye
Image 7: Right lower lid (surface illumination above, retroillumination below) shows >75% gland truncation.
Image 8: Left Eye
Image 9: Left lower lid (surface illumination above, retroillumination below) showing similar truncation as the right lid.
I started her on standard dry eye treatments, including EZ Tears™ Omega-3, D.E.R.M warm compresses daily, and Systane® Balance as needed and scheduled a one month dry eye follow-up. We also had her back sooner for a contact lens fitting and compared DAILIES TOTAL 1® and Biotrue® ONEday daily disposables.
At her dry eye follow-up, she had been using artificial tears and noted the warm compresses helped, but her eyes felt better when not wearing contact lenses. She had stopped taking the EZ Tears. The following were her exam findings.
- MGE: 4 glands open OD (temporally), 1 open OS
- 1+ lower palpebral papillae OU
- Pinguecula nasal and temporal OU
- TBUT: <10 seconds
Based on her symptoms, LipiScan® images showing severe truncation, reduced MGE scores, and previous failed treatments, I recommended LipiFlow®, and we proceeded with an uneventful procedure. Where appropriate, I also debride the lid margins with a golf club before application of the Activators. I did so in this case. EZ Tears™ Omega-3’s were restarted and we discussed the importance of blinking exercises.
At her LipiFlow® follow-up, the patient stated she was “doing wonderful and is very pleased with the results”. She was compliant with her omega-3 and warm compresses and felt no need for any artificial tears. MGE scores had increased to 9-10 OD and 5-6 in OS. I debrided the lid margins again and stressed the importance of lid massage after the warm compresses in hopes of getting a few more glands to express.
At her annual exam, one year later, she stated that her eyes have felt good and were still comfortable since her LipiFlow® treatment. She very occasionally used artificial tears.
Treatment Summary:
| Pre-LipiFlow® Treatment | Post-LipiFlow® Treatment |
|---|---|
| 4 MGE OD 1 MGE OS | 9-10 MGE OD 5-6 MGE OS |
Case 3: SG
SG is a 25 YOWF who came to my office for a routine exam. SG had no visual complaints since having PRK performed in 2014 OU. Her secondary complaint consisted of mild dryness that happened any time of the day. SG was using ClearEyes®to help with this. She stated she had mornings where her eyes were so dry it felt like they were ripping when she opened her eyes. SG was using gel drops QHS PRN to help. SG admitted to having a little dryness before PRK when she wore contact lenses. The initial exam findings are below:
- Grade 2 meibum with multiple non-secreting glands OU
- Grade 1 lower palpebral injection and trace diffuse bulbar injection OU
- Thin tear film and TBUT 5 seconds OU
- Trace scattered SPK and negative inferior staining OD, Grade 1 SPK inferior ½ OS
- Gland atrophy and truncation on LipiScan® (see images below)
Image 10: Right Eye: LipiScan® shows multiple, complete gland atrophy and 0-75% truncation with mild tortuosity.
Image 11: Left Eye: LipiScan® shows 0-50% truncation with mild tortuosity.
I began treatment of Blink® Tears Lubricating Eye Drops two to three times per day and Refresh Liquigel® QHS due to the SPK, negative staining, and patient history. I stressed the need to discontinue ClearEyes® due to rebound redness occurring. We discussed punctal plugs, Restasis® or Xiidra® as potential future treatment options, but needed her back for further evaluation. At her follow-up we discovered the MGE scores:
- OD: 1-2 glands open with MGE
- OS: 3 glands open with MGE
- Her SPEED II Questionnaire tallied 17 out of 28.
- She was also negative for InflammaDry OU.
Based on the reduced MGE scores, negative InflammaDry, and the LipiScan® images, we decided to proceed with LipiFlow® treatment with the possible need for Restasis® adjunctive therapy due to the thin tear film. We also started warm compresses three to four times per week to keep the glands flowing after LipiFlow® and omega-3 supplements due to the thickened meibum. She was educated to avoid putting make-up along the lid margin as this was a potential contributing factor to the atrophy seen.
At her six week LipiFlow® follow-up, SG reported her dryness was better now and symptoms were mild rather than moderate to severe. She stated she felt like she had more tears. She was not compliant with warm compresses, only using Blink® Tears occasionally in the morning when her eyes were dry and was not taking the omega-3s regularly. She was not using the Refresh Liquigel® QHS.
- MGE: 7-8 glands open with MGE OU, more expressing with increased pressure.
- Grade 2-3 meibum
- SPEED II questionnaire reduced to 9 out of 28. (My ultimate goal is to achieve a 6 or below).
I stressed the importance of hot compresses daily and the need for regular omega-3 supplements to thin the meibum. We held off on prescribing Restasis® to see how she does when compliant with treatment. We decided on an RTC of PRN with dryness, but she hasn’t needed an appointment for over six months now.
It is important to note that this patient had significant gland atrophy and obstruction at the age of 25. Do not discount dry eye symptoms in the younger patient population.
Treatment Summary:
| Pre-LipiFlow® Treatment | Post-LipiFlow® Treatment |
|---|---|
| 1-2 MGE OD 3 MGE OS SPEED II: 17/28 | 7-8 MGE OD 7-8 MGE OS SPEED II: 9/28 |
The SPEED II questionnaire was a nice indicator of treatment success in this last case and something I am actively trying to get my staff to complete regularly. It only takes a couple of minutes to complete, but must be built into your technicians work-up system to make it routine. These cases also highlight how crucial it is for a post-LipiFlow® follow-up appointment to reinforce the need for warm compresses and regular omega-3 supplementation, as both of these are known treatments with poor patient compliance.
It is important to notice in these cases how the discussion of their condition started at the comprehensive exam. This gives them time to digest their diagnosis and formulate questions for their follow-up visit while paying closer attention for symptoms. To limit information overload and to help with patient compliance, I hand all dry eye patients a standard dry eye document that further reviews and explains their treatments and conditions. I also hand out a LipiFlow® brochure if their initial LipiScan® shows a significant amount of gland atrophy or changes.
Starting baseline treatment at their initial visit enables them to start incorporating it into their routine and permits us to look for any improvements in signs and symptoms at their subsequent visit. Also, starting warm compresses early at the initial exam or dry eye work-up, before LipiFlow®, may help improve MGS scores at the 12 month mark post-LipiFlow® (see the bar graph above). The dry eye follow-up allows time for further investigations and patient questions as well as a review of patient compliance and further discussion of LipiFlow® when necessary. We know from research that the sooner you treat, the better the prognosis with LipiFlow®, and thus, we strongly encourage timely treatment with LipiFlow® for needing meibomian gland dysfunction candidates. These LipiFlow® patients achieved long lasting relief from their dryness by increased gland function, without the use of medications.
Case Summary:
| Pre-LipiFlow® Treatment | Post-LipiFlow® Treatment | |
|---|---|---|
| Case #1, 48YOWF | 2-3 MGE OU | 13-15 MGE OU |
| Case #2, 51YOWF | 4 MGE OD 1 MGE OS | 9-10 MGE OD 5-6 MGE OS |
| Case #3, 25YOWF | 1-2 MGE OD 3 MGE OS SPEED II: 17/28 | 7-8 MGE OD 7-8 MGE OS SPEED II: 9/28 |
Check out this demo of LipiScan®
How To Bring LipiView® II, LipiScan® and LipiFlow® to Your Practice
The LipiScan® Dynamic Meibomian Image is a critical piece of equipment for taking care of and educating dry eye patients. It is packed into a small footprint and boasts sleek edges that will enhance the high-tech, medical appearance of any office. It is straightforward for both patients and technicians and provides high-definition images. Meibography is critical for patient education and helping patients understand the importance (and urgency) of the LipiFlow® procedure. Showing the patient their own glands and the changes occurring in them is paramount in educating the patient that they are in need of treatment. This is especially true for those that do not clearly present with symptoms. Because I am big on patient education, and we know the importance of meibography, we offer LipiScan® complimentary to our patients.
During pretesting of a routine exam, our techs will ask if they have any redness, burning, or dryness, and if a patient answers yes to any of those questions, the technician will perform LipiScan® on the lower lid of both eyes. If there is significant atrophy, they will flip the lids and will also perform the procedure on the upper lids. Occasionally, we will perform LipiScan® as the patient is leaving their exam if we discover signs or symptoms of dryness during the exam. We then review these photos at the patient’s one month dry eye follow-up.
Prior to purchasing LipiScan®, our practice considered other instruments. Johnson & Johnson Vision graciously agreed to bring a LipiScan® to our office so we could use it and see how easy it was for our techs to perform. The simplicity, quickness, small footprint, and lesser cost of the equipment (based on LipiScan® and Keratograph 5M manufacturer quotes) made it an easy choice to choose LipiScan® over other alternatives. Furthermore, the Keratograph dry eye printout measured things such as redness and a dynamic TBUT, but we were discouraged to hear measurements were often unreliable and inconsistent and could show worsening after treatment. This made us question whether these readings were accurate or too dynamic to measure in order to effectively monitor treatment.
LipiScan® Feature List:
- $12,950
- 12” wide x 16” depth footprint.
- Manual chin rest for patient alignment.
- Lid Everter/Transilluminator incorporated into the instrument
- Large, easy to see touchscreen with one-click image capture
- Surface and transillumination images
The LipiView® II Ocular Surface Interferometer has a slightly larger footprint than the LipiScan®, but allows you to image the lipid layer in real time and measure the thickness to nanometer accuracy.
Image 13: The Lipiview® II Ocular Surface Interferometer
It also allows for video footage of partial blinks. Partial blinks, as opposed to decreased blink rate, are suspected to be the main reason patients have computer vision symptoms or worsening dryness when working on a computer or digital device.
Lipiview® II:
- $36,950
- Realtime lipid layer observation and thickness measurement
- Partial blink videos
The LipiFlow® console has an even smaller footprint than the LipiScan® with a similar sleek design for an excellent office aesthetic. It has the same touchscreen interface as the LipiScan®. I have my techs set up the patient and instrumentation prior to me entering the room to improve efficiency.
LipiFlow®:
- $29,950
- Activators are $100 each (sold in boxes of 10) Price was reduced on Feb. 11th, down from $175
Image 14: The LipiFlow® instrument
My Protocol for Using LipiFlow® in Practice
Currently, we have a few patient criteria for performing LipiFlow®. Our three criteria include:
- Reduced MGE score (we are cautious with recommendation if the MGE reveals over 14-15 glands)
- Gland engorgement, truncation, or atrophy
- Clearly displayed symptoms
So long as a patient meets criteria one, and either criteria two or three, we recommend Lipiflow®.
If there is no blepharitis, we perform a simple lid debridement with a Golf Club Spud.
I discuss the procedure at the appointment before they schedule their LipiFlow® treatment and then briefly review the procedure again before performing it. All patients sign a procedure consent form. Most patients don’t wear any make-up to their appointment, but if they do, I use an OCuSOFT lid scrub to remove any make-up prior to starting. I then apply one drop of proparacaine to each eye for patient comfort. After prepping the patient for LipiFlow®, I lean them back in the exam chair and get them comfortable. The Activator cords are attached to the individual Activators and left in their sterile bags before I enter the room so that they are ready to remove and place directly on the patient’s eyes.
Applying the Activator is easy and the Activators fit most eyes. The Activator may not fit all eyes, such as eyes with small palpebral fornices. In almost three years of performing LipiFlow® treatments, I have had only one patient I was not able to apply the Activators on.
Performing the treatment:
- Step 1: Place 1-2 drops of topical anesthetic to each eye being treated. Have the patient look down
- Step 2: With one hand, pull the upper lid up and apply a small amount of pressure to reveal the gap between the lid and the globe. Tilt the applicator to a 45 degree angle with the cord temporal and insert the white shell under the upper lid.
- Step 3: Have the patient look straight ahead (do NOT have them look up as it can undo Step 2), and then gently pull down the lower lid until the white shell smoothly slides behind the lower lid.
- Step 4: Check the lateral canthus to make sure the air-bladders are resting against the upper and lower lids, pulling at the temporal canthus as needed. Then apply a piece of LipiFlow® tape to the Activator and nose to secure the device in place. Use extra tape for loose lids or large palpebral fissures
- Step 5: Repeat Steps 1-4 for the other eye
Note: you can do this procedure on only one eye, but it is recommended to perform bilateral at the same time. We charge more for single eye procedures due to tech and doctor set-up time. No patients have opted for only one eye.
Image 15: Inserting the Activator.
Image 16: Application of LipiFlow® tape.
Once the Activators are in place and secure, my patient script sounds like this:
“Ok, are you ready to begin? When I press start, the machine will make a noise and the Activators will squeeze; don’t be alarmed.”
“The Activators are warming up, once they reach 104 degrees Fahrenheit the pressure and timer will start and we will have 12 minutes. There may be a difference of a couple of seconds between eyes; that is okay. We will reach a max temperature of ~109 degrees, which is the melting point of the oil in your glands. It won’t feel hot, but will feel like a warm massage”
“You will feel a constant pressure, then it will release, and you will feel a slow stepwise increase in pressure followed by a quick pulsatile pressure. It will repeat that sequence twice and then it will be done.”
“My tech will be in here the entire time with you, and if you need to pause it at any time let them know.”
“Sit back and relax!”
Image 17: Activators in place and patient ready for treatment.
At that point I leave the room and my tech discusses our previous treatments, usually consisting of omega-3 supplements, daily warm compresses with lid massage to maintain gland openings, and artificial tears as needed. We tell the patient their eyes may feel a little more dry for one to two weeks after the procedure since we are essentially removing the oil, and they will need time to reproduce and upregulate. We then see them back in six to eight weeks to re-check MGE and TBUT and see how they are doing.
Rechecking MGE is critical to know if LipiFlow® would be an effective future treatment, if the need arises for a repeated treatment. If the MGE score has not improved, other treatments may be necessary to improve meibum quality and flow (i.e., lid debridement, blepharitis control, better omega-3 compliance, doxycycline for rosacea patients, etc).
Understanding Return on Investment of Bringing This Technology To Your Practice
Johnson & Johnson is exceptionally easy to work with. They came out to our practice to help with training. Associate doctors were all able to practice inserting and removing the Activators on each other. After we were properly trained, I trained our techs on removing the Activators as well shortly thereafter, and eventually completely delegated this task to them which has helped with our flow and efficiency.
Once we committed to purchasing both the LipiScan® and LipiFlow® instruments, we immediately ran a diagnosis code report to identify all of our dry eye patients (H16.223 was the commonly used ICD 10 code at the time). We then scheduled two full days in back-to-back weeks where we were running a complimentary LipiScan® every 15 minutes on our dry eye patients. A Johnson & Johnson Vision representative was at our office the entire day and helped the techs set-up, take down, and capture the LipiScan® images. The doctor then would look over the images and review them with the patient and either schedule them back for MGE and LipiFlow® or a routine dry eye follow-up based on the results.
At the time of purchase of LipiFlow®, we were only the fourth clinic offering LipiFlow® in our city and surrounding area of approximately 500,000 people. We determined the market rate for LipiFlow® that would result in a net revenue of $545 per procedure in order to cover the cost of chair time and the LipiFlow® machine based on a conservative benchmark of two procedures a month. We determined we would only need to perform two treatments a month to break even on the cost of our LipiScan® and LipiFlow® system. If you performed just one LipiFlow® per week you could generate over $45,000 dollars in gross revenue for your practice.
In 2017, our first full year of having the LipiScan® and LipiFlow® system, we performed 28 LipiFlow® procedures. In 2018, we increased by one and performed 29 procedures. We are hoping to significantly increase the availability to our patients with a current, lower price thanks to a decrease in the cost of Activators. With the pricing change, we are still earning $500 net revenue per procedure. We are hoping an increase in treatment volume will cover the difference in net revenue by bringing the procedure to a price point that is more affordable to our patients.
Why to Bring LipiFlow® to Your Practice
LipiFlow® is easily the treatment that I am most confident will bring lasting relief to the vast majority of my dry eye patients all while preserving delicate glands. A lot of my dry eye patients come to me with chronic pain or irritation from dryness that has either been ignored by previous providers or they have failed on multiple medications and treatments. LipiFlow® offers a simple, safe, and highly effective treatment with relief from their symptoms with a single treatment and single office visit.
While catching meibomian gland dysfunction early and treating early is the ideal plan, it is comforting to have clinical evidence that LipiFlow® can even be effective in late stage meibomian gland dysfunction with severe gland truncation and dropout. It would be even more exciting if we had statistically significant clinical evidence that we could reactivate glands that appear to be atrophied. Before LipiFlow®, we were using external warm compresses with individual lid expression using a meibomian gland paddle. This procedure was time-consuming, difficult, and uncomfortable for the patient. There is evidence that manual expression works. But it requires multiple treatments to be as effective and puts the patient through an unpleasant experience, and requires more chair time for the clinician. Before LipiFlow®, we used oral medications like azithromycin and doxycyline to help with gland inflammation. While these medications still have a place in treatment, they have serious side effects, and they were constantly resisted by patients who didn’t want to kill good bacteria.
Secondly, there is a huge need for LipiFlow® in the normal patient population due to the prevalence of MGD. According to the DEWS II research results, prevalence of dry eye ranges from 5-50% worldwide. Using a conservative 25% prevalence, if you see 12 patients per day, statistically three of those patients could have some combination of signs and/or symptoms of dryness. That means you probably have about 15 dry eye patients per week. We know that 86% of dry eye patients have meibomian gland dysfunction, which means you have the potential for up to 13 LipiFlow® procedures per week if you heed the proven research! You are doing your meibomian gland dysfunction patients a disservice if you are not offering them LipiFlow® as a treatment option.
Lastly, LipiFlow® is a great way to separate yourself as an optometrist and give you a specialization and medical presence. With conservative estimates, you can get a complete ROI from your LipiFlow® and LipiScan® in only one year! At the new price point and the potential for 13 LipiFlow® procedures per week, there is a potential for over $473,000 in revenue! I am truly hoping the lower Activator cost will bring this treatment into an affordable range for even more patients.
I challenge all optometrists to be active and thorough when evaluating their patients dry eye symptoms and recall that 86% of dry eye patients have or will develop symptomatic meibomian gland dysfunction. Now that we have an easy, straightforward way of assessing for MGD and an excellent, effective, first-line treatment with LipiFlow®, giving your patients the relief they are looking for is simple and unequivocal.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for LipiFlow® Thermal Pulsation System
Rx Only
INDICATIONS
The LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
CONTRAINDICATIONS
Do not use the LipiFlow® System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.
- Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
- Ocular injury within prior 3 months
- Ocular herpes of eye or eyelid within prior 3 months
- Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
- Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
- Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
- Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
PRECAUTIONS
The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices.
Use of the LipiFlow® System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
- Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use.
- Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren’s syndrome)
- Taking medications known to cause dryness (e.g., isotretinoin (Accutane®) and systemic antihistamines)
- Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)
In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.
ADVERSE EFFECTS
Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in:
- Eyelid/eye pain requiring discontinuation of the treatment procedure;
- Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion);
- Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)); and
- Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).
Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include:
- Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens;
- Physical pressure-induced injury to the eyelid; and
- Ocular surface (corneal) infection.
ATTENTION
Reference the LipiFlow® Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.
References
- Kelly K. Nichols, Gary N. Foulks, Anthony J. Bron, Ben J. Glasgow, Murat Dogru, Kazuo Tsubota, Michael A. Lemp, David A. Sullivan; The International Workshop on Meibomian Gland Dysfunction: Executive Summary. Invest. Ophthalmol. Vis. Sci. 2011;52(4):1922-1929. doi: 10.1167/iovs.10-6997a.
- Hellem, A. What You Should Know About Meibomian Gland Dysfunction (MGD). All About Vision. April 2019. <https://www.allaboutvision.com/conditions/meibomian-gland.htm.>
- Glaucoma Eye Drops Show Correlation With MGD. Review of Optometry. March 29th, 2018.
- Korb, D. R., & Blackie, C. A. (2015). “Dry Eye” Is the Wrong Diagnosis for Millions. Optometry and Vision Science, 92(9), E350-E354.
- Blackie, C. A., Coleman, C.A., Holland, E.J. “The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.” Clinical Ophthalmology, 2016; 10:1385–1396.
- Greiner, J. V. (2016). Long-Term (3 Year) Effects of a Single Thermal Pulsation System Treatment on Meibomian Gland Function and Dry Eye Symptoms. Eye & Contact Lens: Science & Clinical Practice, 42(2), 99-107.
- Epitropoulos, A., Goslin, K., Bedi, R., & Blackie, C. (2017). Meibomian gland dysfunction patients with novel Sjögren’s syndrome biomarkers benefit significantly from a single vectored thermal pulsation procedure: A retrospective analysis. Clinical Ophthalmology, 11, 701-706.
- Schallhorn, Craig S, Schallhorn, Julie M, Hannan, Stephen, & Schallhorn, Steven C. (2017). Effectiveness of an Eyelid Thermal Pulsation Procedure to Treat Recalcitrant Dry Eye Symptoms After Laser Vision Correction. Journal of Refractive Surgery (Thorofare, N.J. : 1995), 33(1), 30-36.
- Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous deficient and evaporative dry eye in a clinic based patient cohort: a retrospective study. Cornea. 2012; 31(5):472-478.
- DFU, LipiScan®
- Report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop. Ocul Surf. 2007 April;5(116)
- Korb DK, Henriquez AS. Meibomian Gland Dysfunction and contact lens intolerance. J Am Optometric Assoc. 1980;51(3):243-251
- US MGE DFU
- Lane SS, et al. A new system, the LipiFlow®, for the treatment of meibomian gland dysfunction. Cornea. 2012 Apr;31(4):396-404
LIPIFLOW, LIPIVIEW II, LIPISCAN and the MEIBOMIAN GLAND EVALUATOR are trademarks of TearScience, Inc. © Johnson & Johnson Surgical Vision, Inc. 2019. All other trademarks are the intellectual property of their respective owners.
PP2019MLT4180
