Optimization of ocular surface requires newer treatment options

Mark S. Milner, MD, FACS, and Sheri Rowen, MD, FACS, discuss the benefits of LipiFlow and intense pulsed light.

Issue: October 25, 2014

CEDARS Debates is a monthly feature in Ocular Surgery News. CEDARS — Cornea, External Disease, and Refractive Surgery Society — is a group of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.

Lid margin disease and dry eye disease have long been troublesome for both the patient and the physician. They are difficult to treat, and until recent years, there have been few reliable treatment options. Lately, attention has been focused on the effect of ocular surface disease on visual performance. This has become particularly relevant when a patient undergoes refractive surgery and refractive cataract surgery. Optimization of the ocular surface around the time of surgery is critical to obtaining the best outcomes. This month, Dr. Mark Milner and Dr. Sheri Rowen discuss LipiFlow (TearScience) and intense pulsed light in the treatment of ocular surface disease. We hope you enjoy this discussion.

Kenneth A. Beckman, MD, FACS
OSN CEDARS Debates Editor

LipiFlow worth adding to armamentarium

Mark Milner

The ocular surface and tear film can no longer be ignored, nor should they be. We have long been aware of the problems of chronic dry eye and the damage that can occur to the ocular surface. Complications can range from chronic irritation and blurry vision to infections and corneal melts. In addition, with the growing number of refractive procedures and premium IOL surgeries, it is becoming increasingly obvious how important the tear film is to vision and, therefore, how paramount it is to treat dysfunctional tear syndrome in order to obtain excellent visual outcomes. In the past, treating dry eye and tear film abnormalities has been frustrating for both the patient and physician with limited options and minimal success. However, there are innovative treatments on the horizon to address these abnormalities.

The teaching has been to separate dry eye syndrome into aqueous deficiency and evaporative tear syndrome. Evaporative tear syndrome could further be subdivided into goblet cell deficiency (as seen in conjunctival scarring), blepharitis/meibomian gland dysfunction (MGD) and lid function abnormalities (such as lagophthalmos and incomplete or partial blink). MGD makes up the majority of evaporative tear syndrome cases. The standard treatments for MGD, such as warm compresses, lid hygiene, topical and oral antibiotics, and topical anti-inflammatory agents, have been well established and are beyond the scope of this article. Now the debate has begun over whether any or all of the “procedural treatments,” such as intense pulsed light therapy, LipiFlow and meibomian gland probing, should be incorporated into the treatment regimen. I will make the argument for adopting LipiFlow into your practice.

All of the treatments mentioned above appear to be efficacious and safe, but I made the decision to incorporate LipiFlow into my practice almost 2 years ago, and it has been an excellent adjunct to the standard therapies for my MGD patients.

LipiFlow is a thermal pulsation system that treats the meibomian gland obstruction of the upper and lower lids simultaneously in a safe 12-minute procedure. The current challenges with warm compresses, in addition to the high incidence of poor compliance, are that the heat applied is usually inadequate in temperature and time, applied mostly to the upper lids rather than lower lids, and is applied to the outer surface of the lids, farther away from the meibomian glands. The LipiFlow device consists of an activator that is easily inserted into each eye and has a shield to protect the eye, with a lid warmer on the back surface of the shield that sits adjacent to the inside of the lid and juxtaposed to the meibomian glands of the upper and lower lids. The warmer heats the lids to 108°. The outside of the activator has upper and lower air bladders, composed of silicone, that are inflatable and provide pulsations to compress the lids and express the glands. LipiFlow works because it provides the exact amount of heat to the exact location for the exact amount of time and couples it with a reproducible, effective series of compresses to evacuate the glands. LipiFlow is like “rebooting the computer,” eliminating the glands of the abnormal secretions and allowing the glands to begin to produce more healthy oils.

Clinical studies show that LipiFlow works for a majority of patients, and my experience has been consistent with this. In an open-label, randomized, controlled multicenter trial of LipiFlow compared with warm compresses, 90% of patients had an improvement in total meibomian gland score and 79% of patients reported improvements in overall dry eye symptoms. As for safety, LipiFlow was shown to have no unanticipated or serious device-related adverse events. The overall safety profile showed a low occurrence of non-serious, transient side effects consisting of mild discomfort and itching, requiring no treatment. On a scale of 0 to 10, mean discomfort score was 1.4 ± 1.4 during LipiFlow and 0.2 ± 0.6 immediately after treatment. In my experience, LipiFlow is one of the safest treatments that I offer, and there have been no reported adverse events in my practice since I incorporated it into my regimen. Discussions with other users show that the duration of effect usually lasts from 6 to 24 months. A majority of my patients have seen the benefits last in the 18- to 24-month range.

In my experience, the following may help to increase your success with LipiFlow:

1. As mentioned above, LipiFlow is like “rebooting the computer.” The glands are relieved of abnormal oils and can continue to make healthier oils if the treatments used to improve and control inflammation, such as off-label Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), off-label AzaSite (azithromycin ophthalmic solution, Akorn) and oral doxycycline, are continued. This may extend the duration of effect.

2. Managing expectations is critical. I have had some patients not experience any improvement in symptoms until 1 to 3 months after treatment.

3. During the first month, the ocular surface may be more inflamed as the abnormal oils are evacuated. Therefore, I use a topical steroid twice daily for 2 to 4 weeks after the treatment.

4. Make sure that the activators are in good position throughout the procedure. If the activator shifts position (for example, this may be more likely in patients with floppy lid syndrome), pause the procedure and reposition.

So why add LipiFlow to your practice? It is a 12-minute, almost no-risk, easy procedure that improves patients’ symptoms about 80% of the time and improves meibomian gland secretions in more than 90% of patients. I have had many happy patients who feel that LipiFlow has been the only thing to help or the one thing in a series of treatments that has put them “over the edge” on the road to improvement.

Reference:

Lane SS, et al. Cornea. 2012;doi:10.1097/ICO.0b013e318239aaea.

For more information:

Mark S. Milner, MD, FACS, can be reached at the Eye Center of Southern Connencticut, 2880 Old Dixwell Ave., Hamden, CT 06518; 203-248-6365, email: eyecentermm@hotmail.com.
Disclosure: Milner is a speaker for Allergan, TearScience and Bausch + Lomb and a consultant for Allergan.

PAGE BREAK

Treatment with IPL and LipiFlow

Sheri Rowen

I first started treating meibomian gland dysfunction (MGD) with intense pulsed light (IPL) 3 years ago, and it was then that I realized what we were missing with our dry eye management. So many of us had neglected to examine the properties of dysfunctional glands, and this was a fantastic way to appreciate what happens to these glands when they are imbalanced. In fact, a significant percentage of the lids did not look inflamed externally on initial presentation. When placing a cotton swab and applying pressure externally, the gland did not always appear diseased. It was only when I would place the cotton swab inside the lid and apply external pressure against it with my finger did I appreciate what was inside. This was made more readily apparent after a treatment of IPL. Now I was finally able to diagnose non-obvious MGD. Seeing this and learning about the contents of the glands have given me a much better understanding of why it is so difficult to treat dry eye without concurrent lid treatment. The glands need to be evacuated of their malfunctioning thick, globular, blocked contents so that new balanced, free-flowing oil can be produced. Using IPL, I now could see improvement of the glands with time and document the new quality of the oil in the glands.

I found that the treatments, although fairly rapid, required a good bit of chair time, and it became increasingly difficult to fit these patients in my regular schedule because they require multiple monthly treatments. The patients accepted these treatments financially because the initial investment was not terribly costly and then returned for more as they perceived the improvement, even after an initial treatment, so there became an issue in scheduling. There is some discomfort with adequate expression in some patients, but many were willing to tolerate it for the benefit of symptomatic and clinical improvement.

I then brought the LipiFlow to my practice 2.5 years ago to help me with the patient throughput and found it extremely effective in treating dry eye syndrome and MGD. First, I would use my newly found skills in diagnosing the lid problem. Then, after I explained that we now had a single but more expensive treatment option, many patients opted to utilize the newer technology so they could be in and out and not have to schedule multiple treatments. I also explained that this procedure was innately more comfortable, like a spa treatment for the eyes. The added benefit for me was that after the initial consultation, the patient could sit in another room for 12 minutes having the treatment while I was able to see the next patient. Patients did not complain about the treatment, and I was documenting 84% patient satisfaction, similar to the U.S. Food and Drug Administration clinical trials. I subsequently learned that part of the issue of MGD was the keratinization of the external gland orifices at the lid margin. After initial debridement of the margins of these keratin plugs with a spud, I obtained even better results.

Now, I continue to utilize both treatments. For those patients who experienced minimal or short-term effect from the LipiFlow, I supplement it with additional IPL treatments with manual expression. Sometimes it takes more force to unblock and maintain these lids. I will also use IPL as a supplement at 12 months or more to maintain the effect of the LipiFlow, if needed. I personally maintained my own effect from the LipiFlow for more than 2 years, as do most of my patients, many of whom I might manually debride and express so the glands will keep flowing throughout the year. This is more comfortable and effective than probing the glands, as long as the contents can be evacuated.

The benefits of the synergy of IPL and LipiFlow have been advantageous for my dry eye practice both as a learning tool and for interchangeable treatments, as needed. I encourage all of us to not wait until our patients are 40 or 50 years old to finally examine their internal meibomian gland contents, but to change our paradigm to early diagnosis and intervention This problem actually begins at an early age, and many of my current patients are in their 20s. When I see what is occurring in their glands, I can just imagine how bad their glands would be at 50 years old, when they would normally finally be diagnosed. Dry eye syndrome is a multifactorial disease of inflammation and MGD that we need to address at an early age to prevent dysfunction. Patients should have early eye physicals even if they do not require visual correction, as our diets and environment also play into earlier occurrence. With early detection and treatment to supplement patients’ oils with the PRN triglyceride form of omega-3, and possible expression to prevent the buildup of plugged oil and topical cyclosporine, we will be able to prevent many cases of significant ocular surface disease.

For more information:

Sheri Rowen, MD, FACS, can be reached at Rowen Vision & Cosmetic Center, 301 Saint Paul Place, Suite 514, Baltimore, MD 21202; 410-332-9500; email: srowen10@gmail.com.
Disclosure: Rowen served as a speaker for TearScience.