Toyos presents Intense Pulse Light for Dry Eye Disease at 12th annual ISOPT Clinical Meeting


Rolando Toyos, MD lectured at the 12th annual International Symposium on Ocular Pharmacology and Therapeutics meeting in Berlin. This year the meeting is focused on drugs and devices that are changing the way eye doctors are practicing. The meeting has always been about innovations that will be utilized in daily practice. This is the fourth year that Dr. Toyos has been invited to speak at this prestigious meeting. ISOPT has always held special lectures on Dry Eye Disease Treatment. The year featured speakers from the USA, Germany, Singapore, and Spain.

 

Dr. Toyos presented his published research on the use of Intense Pulse Light for dry eye. Dr. Toyos utilizes the IPL technology that he developed – Dermamed Diamond with DES. He also presented a soon to be published study looking at biomarkers after IPL treatment. He concluded his lecture presenting information on his at home light device for dry eye treatment, The Q. Toyos Clinic presented data on The Q at the American Society of Cataract and Refractive Surgery showing improvement in signs and symptoms of patients who used the device at least twice a week for 3 months. The Q has now been in use only at Toyos Clinic this year with rave reviews from patients. Dr. Toyos holds several patents on light base treatments for dry eye. The clinic has thought about delivering The Q to other clinics similar to the IPL roll out where Dr. Toyos personally trains the doctors and staff of each clinic that has the IPL technology.

 

 

toyos_rolando

  Dr. Toyos’ hands on approach to teaching over the last seven years has led to several clinics like Duke and The Mayo Clinic to produce similar positive results that Dr. Toyos reported in the Journal for Laser Medicine.

 

For now if patients want The Q they will have to call Toyos Clinic.

 

After the lecture Dr. Toyos was interviewed by a European Ophthalmology Journal that plans a special Dry Eye Disease, DED, section highlighting the latest treatments. The interviewer suffers from DED and is planning a consultation with Dr. Toyos in Memphis or Nashville. Over the years the clinic has seen patients from several foreign countries. The clinic has a staff member that can help coordinate travel, exam, and treatment. Dr. Toyos has another presentation later in the meeting concerning new treatments in cataract surgery. The clinic is currently conducting several cataract research projects. if you qualify for studies you are eligible to free medications and possible compensation. As always the clinic has several dry eye studies as well. For more information call one of the clinics in your area. Or you can email our study coordinator Pat Mathey at Pmathey@toyosclinic.com.



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IPL Effective for Dry Eye, MGD, Studies Show


Researchers and experienced eye care providers are supporting the use of intense pulsed light to treat patients with meibomian gland dysfunction and dry eye disease.

 

Meibomian gland dysfunction (MGD) is considered to be one of the leading causes of dry eye and affects between 4% and 20% of Caucasians and more than 60% of Asian populations, according to Nichols and colleagues. These researchers noted in Investigative Ophthalmology and Visual Science that treatment of the disorder is varied and inconsistent.

 

“Underreporting makes it difficult to assess practice patterns accurately, but most practitioners agree that underdiagnosis is common, and clinical follow-up irregular,” they said.

 

Several studies have also reported that treatment of MGD is often ineffective, leaving patients with few options.

 

Intense pulsed light (IPL) has emerged as a possible therapy for patients with MGD who have run out of other options. The treatment, which originated in dermatology, was found to help patients with dry eye disease (DED) and MGD who happened to be receiving a treatment for their skin.

 

“The leap in understanding is that, for many people, dry eye is part of a skin condition, and that the meibomian glands in the eyelid skin are the problem, or at least a major contributor to the vicious cycle of inflammatory dry eye,” Joanne F. Shen, MD, an ophthalmologist at the Mayo Clinic in Arizona, told Primary Care Optometry News in an interview.

 

Dr. Rolando Toyos and colleagues wrote in a study published in Photomedicine and Laser Surgery in January: “In 2002, we began to observe that some of our patients treated with IPL showed improvement in MGD and DED. Based on these observations, the Toyos Clinic continued to develop and refine the treatment. Since that time, we have presented study results at several meetings showing how IPL improves MGD and DED. Over the years, we have perfected the technique and technology to maximize results and minimize complications.”

 

The researchers explained the process behind the technology: “IPL has been used in dermatology practices for several years as a treatment for rosacea and acne. IPL uses a Xenon flashlamp to emit wavelengths of light from 400 nm to 1,200 nm. When placed on the light, a filter restricts the wavelength to the visible light range of ∼500 nm. When applied to the skin, this 500 nm light causes the blood cells in the abnormal telangiectasias to absorb the light, coagulate and, finally, to close the blood vessels.”

 

Toyos and colleagues also helped in developing the specific technology used to treat DED and MGD patients.

 

“In 2007-2008, an IPL treatment technology – the Diamond Q4 by DermaMed Solutions – was specifically configured to our specifications,” they reported.

 

Image 4

 

Joanne F. Shen, MD, shown here administering intense pulsed light therapy, said this is the only treatment that has provided relief to many of her dry eye patients.

Images: Shen JF

 

How it works

 

“Research shows that, at least in other parts of the body, you get an increase in transforming growth factor and probably other growth factors that improve cell function,” Shen explained. “It rejuvenates you, and that probably helps reverse some of the inflammation that we see in the skin.”

 

Toyos said that the goal of the procedure and the machine he and his colleagues helped develop was to stimulate secretion of normal meibum via skin treatment effects on the meibomian glands

 

“We also discovered that dry eye patients are better positioned for gland expression, as IPL seems to liquefy the abnormal viscous meibum and dilate the glands,” they said.

 

They explained that patients have said that their dry eye symptoms have been managed better with gland expression after IPL rather than IPL alone.

 

Administering the treatment

 

Michelle M. Hessen, OD, FAAO, a clinical instructor at the Wilmer Eye Institute and a member of the Ocular Surface Disease and Dry Eye Team, told PCON that IPL can be used to treat dry eye associated with blepharitis and MGD as well as ocular rosacea.

 

“IPL is very easy to use,” she said. “Patients come in for the treatments about every 4 to 5 weeks, and the treatment lasts about 20 to 30 minutes. On average, patients receive four treatments, but it’s completely based on the individual’s progress in terms of how many they need.”

 

Toyos explained that the intensity of the IPL therapy can range from about 8 J/cm2 to 20 J/cm2, depending on age and disease severity.

 

Hessen detailed the treatment process, which she said is not painful.

 

“The patient’s eyes are initially patched for protection, and then cooling gel is applied to the treatment area to absorb some of the heat from the light,” Hessen described. “A handheld device is used to administer pulses of light to the cheek and surrounding area. There are multiple light pulses across those areas.

 

“Afterwards, the cooling gel is removed as well as the eye patches, and meibomian gland expression is performed to express all of the thickened meibum in the glands and to evaluate the quality of the meibum,” Hessen continued. “The patient is usually put on a low-dose anti-inflammatory for 3 days after each treatment for managing inflammation caused by the expression rather than the light therapy itself.”

 

Shen said that patients will receive 18 to 24 pulses of light during each treatment, which can feel warm and occasionally like a tiny rubber band snapping on the skin.

 

“The majority of patients need four or five treatments, but if they improve after three, they can stop there,” Shen stated. “They will typically experience mild mucous discharge and irritation for up to 36 hours and generally have improvement for a few days to a few weeks after their treatment, before regression. After four treatments, typically we see sustained improvement of the patient’s dry eye symptoms.”

 

Image 3

Meibomian gland expression is performed after the light treatment.

 

The results

 

In their study, Toyos and colleagues analyzed clinical benefits of IPL therapy. They conducted a retrospective chart review of 91 patients with severe dry eye, abnormal meibum secretions and abnormal lid margins.

 

Results showed that more than 90% of participants improved over the three metrics they used to assess MGD: improvements in lid margins and meibum evaluated by a physician and self-reported satisfaction.

 

Another 2015 study published inInvestigative Ophthalmology and Visual Science analyzed the efficacy of IPL and found positive results. Craig and colleagues conducted a prospective, double-masked, paired-eye, placebo-controlled study of 28 patients over 45 days.

 

They utilized a third-generation IPL device available in Australia and New Zealand. E>Eye (E-SWIN) was developed for periocular application, according to the study, and is medically certified for treating MGD.

 

“The management of MGD in clinical practice remains challenging, as patient compliance with physician-recommended self-administered therapies is notoriously poor,” Craig and colleagues wrote. “Our results suggest therapeutic potential for sculpted pulse IPL therapy with the E>Eye for the management of MGD, on the basis of significant improvements in lipid layer grade (LLG), tear film stability and reduced symptoms.

 

“The serendipitous discovery of ocular benefits following facial rosacea treatment has led to clinical centers offering IPL as a treatment for MGD on the basis of reports of reduced fluorescein staining and severity of MGD, as well as improvements in visual function and comfort, with some suggesting an apparent cumulative effect,” they continued. “However, evidence of the success of this treatment modality to date has been largely anecdotal, arising from retrospective, open-label evaluations, and no randomized controlled, investigator-masked studies are yet available.”

 

They continued: “The significantly increased lipid quantity on the tear film surface following treatment suggests that outflow of meibum from the glands has been facilitated by the IPL treatment. The benefits, furthermore, appeared to be cumulative, such that after a course of three treatments over 45 days, 82% of treated eyes exhibited significant improvements in their LLG of at least one grade, and 65% exhibited an improvement of at least two lipid grades.”

 

Shen and Hessen reported that they have seen similar results in their patients, who have largely provided them with positive feedback on the treatment.

 

“Many of my patients were referred because nothing else helped them and they had been suffering for almost a decade with dry eye,” Shen said. “They had tried everything available, and IPL was actually the first time they got any relief. So for some patients, it’s been a life-saver. It’s allowed them to function in regular activities like reading and using the computer – very visually intense activities – where before, they were very light sensitive and they couldn’t tolerate wind or sun.”

 

Michelle Hessen

 

Michelle M. Hessen, OD, FAAO   “The feedback we’ve gotten here at John’s Hopkins has been, in general, very good,” Hessen said. “Most patients get improvement from IPL, but it has been a bit variable in terms of the amount of improvement that they get. Some patients have had some mild to moderate improvement and some patients have had a very dramatic improvement, which has allowed them to reduce or discontinue all dry eye-associated drops.”

 

In his published study, Toyos said that IPL candidates must have a Fitzpatrick skin type of 1, 2, 3 or occasionally 4. Other skin types are not suitable for the procedure.

 

Both Hessen and Shen explained that the best candidates for the procedure have not been determined and suggested that more research could help.

 

“Twenty percent of my patients will go through a series of four proper treatments and yet not respond,” Shen explained. “We have determined that patients who are the best candidates for IPL are those who have minimal to no meibomian gland atrophy and have no scarring/keratinization of the lid margin.”

 

They noted that the side effects are relatively minor.

 

“In terms of side effects, there’s concern with very frequent dosing of IPL that you could potentially thin the skin because you are targeting the blood vessels in the superficial skin layers,” Shen said. “So people with very thin skin are concerned with dark circles around their eyes. You have to be careful about doing more than four to five treatments per year.”

 

Hessen cautioned that patients will have some skin sensitivity following the procedure.

 

“Patients have to protect their skin from sunlight for about 2 weeks with some 30 SPF because they are at higher risk for sunburn to their face,” she said. “We also want them to avoid any facial microdermabrasion or anything else that could irritate the area.”

 

Because the treatment is light-related, there is the potential of serious damage.

 

“In terms of risks, obviously you want to shield the eyes completely when performing IPL,” Shen said. “Any sort of pigmented tissue such as the iris will pick up the light and be harmed. There have been case reports in the past where providers – not [eye care professionals] – treated skin, and the patient’s eyes weren’t masked. They were trying to get really close to the eyelid margin and unfortunately caused permanent damage, vision loss and light sensitivity.”

 

 Rolando Toyos

 

Rolando Toyos, MD   Toyos and colleagues reported that 13 patients experienced an adverse event during the trial, and two of those 13 ended treatment. Researchers defined adverse events as cheek swelling, floaters, blistering, conjunctival cysts, light sensitivity, brow or forehead hair loss and facial redness. They wrote that most adverse events resolved themselves within a week.

 

Toyos said that no serious adverse events were reported.

 

How to get started

 

Shen told PCON that Toyos will support eye care providers who purchase the machine through DermaMed.

 

“He’ll actually come and train you and he’s very helpful in answering questions about selecting patients and what to expect,” she explained. “I never had experience using any sort of dermatology light treatments or lasers, so in terms of my medical background, I was able to incorporate this into my dry eye practice quite easily.”

 

Hessen also learned the technology from Toyos.

 

“Dr. Toyos, who really furthered the technology, personally trained me,” she said. “He’s the most knowledgeable and has the most expertise in conducting continued research in this area and continuing to improve the technology to help patients.”– by Chelsea Frajerman

 

References:

 

Craig JP, et al. Invest Ophthalmol Vis Sci. 2015;56(3):1965-1970.
Nichols KK, et al. Invest Ophthalmol Vis Sci. 2011;52(4):1922-1929.
Toyos R, et al. Photomed Laser Surg. 2015;(33)1:41-46.
 

For more information:

 
 
Michelle M. Hessen, OD, FAAO, is a clinical instructor at the Wilmer Eye Institute and is a member of the Ocular Surface Disease and Dry Eye Team. She can be reached at mkubanc1@jhmi.edu.
Joanne F. Shen, MD, works at the Mayo Clinic in Arizona, where she treats chronic dry eye patients. She can be reached atshen.joanne@mayo.edu.
Rolando Toyos, MD, practices in the Toyos Clinic in Germantown, Tenn. He can be reached at rostar80@gmail.com.
 

Disclosures: 

 
Hessen and Shen report no relevant financial disclosures. Toyos is a paid consultant for DermaMed Solutions and a partner in Quantum Ocular Biosciences, which holds several patents in light treatments for dry eye and blepharitis.

 

Read more at healio.com

Copyright & Original: Primary Care Optometry News, May 2015



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Intense Pulsed Light for Treating Dry Eye


Those who experience dry eye produce an abnormal meibum, occasionaly with inflammation and bacteria which can worsen their dry eye symptoms. Some treatments such as anti-inflammatory drops, warm compresses, and lid expression has been somehwhat effective, but intense pulsed light (IPL) seems to be the best up-and-coming option.

 

IPL has been used in dermatology practices as a rosacea treatment for years, but “is a relatively new treatment for MGD and evaporative dry eye,” Dr. Vora said. Gargi K. Vora, MD conducted a retrospective chart review of 100 patients with a diagnosis of meibomian gland dysfunction (MGD) and dry eye syndrome that underwent IPL therapy from September 2012 to August 2014 at two outpatient eye centers. 

 

Treatment for Dry Eye didn’t begin there though, as Rolando Toyos, MD, is credited as far back as 2002 with discovering the potential use of IPL in ocular indications. Some studies by Toyos et al. have hyptothesized that IPL treatment near the lid would cause the abnormal blood vessels to close and noted the effect seemed to be positive on patients with MGD.

 

These studies used the DermaMed Solutions Quadra 4 IPL with its proprietary dry eye mode, and used Fitzpatrick scale to determine the energy parameters, with a xenon flashlight in a band between 400 and 1,300 nm.

 

Other studies have been shown that treatments with IPL thin the meibomian secretions, with a significant decrease in scoring of lid edema, facial telangiectasia, lid vascularity, meibiomian gland severity score, OSDI score, oil flow, and TBUT.

 

 

“We don’t know the exact mechanism of action of the IPL on MGD or dry eye, but we do believe the localized thermal effect causes melting of meibum and a reduction of bacterial/parasitic growth,” Dr. Vora said.

 

Original article on ophthalmologytimes.modernmedicine.com

 



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IPL, MGD, and More


A Webinar by Dr. Cynthia Matossian on IPL for Meibomian Gland Dysfuntion

 

Image 10 Image 11

Click to view the full Cynthia Matossian Webinar



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Photomedicine and Laser Surgery Journal Publishes Paper on the Evidence to Support the Efficacy of Intense Pulsed Light Therapy for Dry Eye


Dr. Rolando Toyos has been persistently working to develop and perfect his dry eye treatment utilizing Intense Pulsed Light (IPL) therapy for close to 14 years now. The fruits of his labor are paying off as lasting relief has been provided to his patients and thousands of others around the world; in addition to recognition among his peers through publication in top peer reviewed journals and lectures at Ophthalmology conferences. His latest paper, Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study was published in the January, 2015 edition of Photomedicine Laser Surgery. The study was co-authored by William McGill and Dustin Briscoe.

 

Dry eye disease is a medical condition of the ocular surface system that affects tear production and/or drainage and is typically caused by meibomian gland dysfunction (MGD). It is one of the most common disorders seen in any eye doctor’s office. Patients with dry eye may complain of eye stinging, burning, itching, redness, irritation or discomfort. For many, the laborious regimens of hourly application of artificial tears, frequent hot compresses and eyelid scrubbing offer little relief and impact quality of life, not to mention that vision may be blurred, causing difficulty viewing a computer, watching television, or seeing clearly while driving. Dry eye suffers are desperate, frustrated and searching for treatments that offer longer lasting relief. Dr. Toyos saw this frustration in his practice and made it his life’s work to find a solution.

 

The treatment was accidentally discovered when Toyos was treating rosacea patients in his practice with IPL and noted improvements in dry eye symptoms. He contacted DermaMed Solutions, the company who distributes the Quadra Q4 IPL machine he was using, and over the course of a year developed a treatment protocol and energy settings that offered the correct balance of energy to both heat the meibum for easy expression and target the blood vessels which were inflamed and triggering the overproduction of meibum. IPL therapy targets the fine blood vessels called telangiectasia, and shuts them down, helping relieve the inflammation. Since development, Dr. Toyos has shared his treatment protocol with over 300 doctors around the world, brining needed relief to patients and doctors frustrated by this challenging condition.

 

The premiere journal in laser surgery, Photomedicine and Laser Surgery, has just published Dr. Toyos’ three year retrospective study on intense pulse light for dry eye disease.  The study shows that the technology and treatment protocol that Dr. Toyos developed is an efficacious way to treat dry eye disease caused by Meibomian Gland Dysfunction – the most common cause of dry eye disease. The treatment was 93% effective in improving the signs and symptoms of dry eye disease.  The Diamond Q4 IPL technology is from DermaMed Solutions, located in Lenni, Pennsylvania.

 

According to Dr. Toyos, “The publication of our research is an important step in bringing this incredible procedure to more dry eye disease-sufferers.”



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Intense Pulsed Light Therapy: Relief for Dry Eyes


A new procedure frees patients from artificial tears and improves their quality of life.

 

Evaporative dry eye is a disease that drastically affects the lives of millions of people, causing chronic pain, discomfort, and loss of vitality. With few treatments available for evaporative dry eye disease—which is caused by meibomian gland dysfunction (MGD)—those who suffer from it often have to deal with an hourly regimen of artificial tears to moisten their eyes, combined with other therapies such as frequent hot compresses and eyelid scrubbing.

 

Duke Eye Center’s Preeya K. Gupta, MD, offers new hope for longer-lasting relief in the form of intense pulsed light (IPL) therapy.

 

The light therapy targets the fine blood vessels called telangiectasias and shuts them down, helping relieve the inflammation.

 

Patients should consider IPL if they have symptoms such as chronic redness in the eyes, irritation, blurry or fluctuating vision, fatigue in the eyes, and not being able to read or use a computer for long periods.

 

IPL is well tolerated by patients. If patients are interested in IPL, Gupta begins with a comprehensive evaluation of the eyes and dryness to determine if they will likely respond well to the therapy. Good candidates have telangiectasias, dysfunction or thickening of the oil secretions, poor flow of the oil secretions, or any signs of chronic inflammation.

 

The procedure itself takes 15 minutes or less. The eyes are protected with a shield. A cool ultrasound gel is placed over the skin of the treatment areas, since the light therapy feels similar to the sensation of mild sunburn. Most patients need four treatments (one treatment every three to six weeks) to see the full benefit of IPL.

 

“These procedures don’t require patients to do anything differently after they go home,” says Gupta. “For busy, active people, it really improves their quality of life, and many patients become less dependent on artificial tears and other dry eye therapies.”

 

However, IPL isn’t for everyone. Because the light is also absorbed by melanin, the pigment molecules in skin, the treatment works best for fair-skinned people.

 

IPL is also not a permanent cure. The blood vessels grow back, and the glands can become dysfunctional again. On average, after the initial four visits, patients will need treatment once a year.

 

A related dry eye therapy, Lipiflow, can also relieve gland obstruction, but it works differently than IPL. The two treatments can be complementary or synergistic, and some of Gupta’s patients receive both.

 

In addition to relieving evaporative dry eye and eliminating the need for constant artificial tears, IPL also appears to help slow the progression of MGD and ocular rosacea. MGD worsens over time with chronic untreated inflammation that can result in the glands scarring, and can become very difficult to treat. Likewise, untreated ocular rosacea can cause scarring of the cornea, which results in loss of vision.

 

Dr

 

Gupta sees the rapid changes that IPL produces and is glad to be at the forefront of evaporative dry eye treatment.

 

“IPL relieves the burden of dry eyes,” she says. “Patients don’t have to think about their eyes as much and can better enjoy their lives.”

 

Intense Pulsed Light Therapy: Relief for Dry Eyes PDF 



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Early Treatment Outcomes in Dry Eye Patients Treated with IPL Therapy


ARVOVEguntaIPLDES

Click here to view the full PDF



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Pilot Study of IPL for Improvement of Severe Dry Eye in Subjects with Ocular Rosacea Related to Inactive Graft-Versus-Host Disease


Image 1

Click here to view the full PDF



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Early Treatment Outcomes in Dry Eye Patients Treated with Intense Pulsed Light (IPL) Therapy


There is a new Abstract from Sravanthi Vegunta and Joanne F Shen, in association with ARVO, that desribes the early treatment results for meibomian gland dysfunction and ocular rosacea in dry eye patients treated with IPL therapy.

 

The most common cause of Dry Eye Syndrome is Evaporative Dry Eye. IPL is FDA approved to treat rosacea, and is now used to treat the ocular rosacea component of dry eye. 68.4% of patients in this study had a positive response to IPL. In summary, it is found that IPL treatment for ocular rosacea can improve dry eye symptoms.

 

 Read the full Abstract at IOVS.org

 

© 2014, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved.



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Dry Eye Essentials


A Broadening Palette of Diagnostic and Treatment Tools Enables Doctors to Provide Patients with the Relief they Deserve

 

Dry eye is running out of places to hide. With the new diagnostic tests and devices available today, doctors can detect a key inflammatory marker of ocular surface disease (OSD) 1, quantify tear osmolarity, which is a proven OSD diagnostic metric 2, help themselves differentiate between dry eye and ocular allergy, and objectively assess tear film quality. In addition, following the development of topical cyclosporine (Restasis, Allergan) as a breakthrough therapy for aqueous-deficient dry eye 3, a new appreciation of meibomian gland dysfunction (MGD) as a primary cause of evaporative dry eye has emerged and led to additional MGD treatment options 5,6.

 

“There has been a very nice evolution with every treatment option and innovation that we’ve experienced, and along the way, there have been some truly revolutionary new developments,” says Darrell E. White, MD, Skyvision Centers, Westlake, OH. “Each of these has enhanced the ability of anyone who looks at the front of the eye to be a dry eye expert. We also have a growing realization that dry eye is a serious problem for patients. It’s satisfying to take care of patients with dry eye and actually great for a practice, too, because it generates new patients of all types.”

 

Tools for Targeting Treatment

 

Given the many new diagnostic tools at his disposal, James E. Croley III, MD, Cataract & Refractive Institute of Florida, no longer uses the Schirmer’s test, but still relies on corneal staining as an indicator of the health of the corneal epithelial cells and to monitor the effectiveness of treatment. Also, as he explains, “I use the TearLab Osmolarity System (TearLab), the LipiView device (Tear Science), and the Oculus Keratograph 5M (Oculus), which taken together, tell me whether a patient’s OSD is predominantly the tear-deficient type or the evaporative type and how severe it is, so I can base my treatment on that. LipiView measures the thickness of the tear film lipid layer. The Keratograph 5M measures several aspects of the tear film, such as break-up time and meniscus height, and it images the meibomian glands in 3D. The latter lets me really see what the glands look like, which can be valuable information. For example, in severe cases of MGD, the patient may have virtually no glands left, which means thermal pulsation with the LipiFlow (Tear Science) device, in general a successful treatment for MGD, would not be the best treatment option.”7 While he doesn’t use in-office testing for allergy, such as the Doctor’s Allergy Formula diagnostic system, Dr. Croley says such tests would be helpful. “Many patients have ocular allergy and dry eye at the same time, and we don’t want one to mask the other,” he says. “I suspect we’ll have more of these types of tests in the future, perhaps assessing lactoferrin and/or IgE.”

 

Dr. White uses the TearLab osmolarity test as well as the InflammaDry (RPS) tear test as part of his dry eye workup. InflammaDry identifies MMP-9, an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease, often before any clinical signs appear. He’s in the process of evaluating in his practice how symptoms correlate with measurable MMP-9 levels and how best to use InflammaDry to guide treatment choices. For quite some time, he’s been using osmolarity to determine which artificial tears he recommends for patients. “I don’t think of osmolarity levels as normal and abnormal as much as high and low, and I can learn from both,” he explains. “For patients with high osmolarity, 308 mOsmol/L or above, I recommend a ‘hydrator’ tear such as TheraTears (Advanced Vision Research) or Refresh Optive (Allergan). For 300 mOsmol/L or lower, especially in conjunction with short tear break-up time, I find tears that provide more ocular surface stabilization, such as Soothe XP (Bausch + Lomb), Blink (Abbott Medical Optics) or Systane Balance (Alcon) to be the best options. I recommend what I consider ‘all-purpose’ tears in situations where the patient is symptomatic, osmolarity is between 300 and 308 mOsmol/L and tear evaporation is not pronounced. Drops that fit into this category include Refresh (Allergan) and Systane Ultra (Alcon).

 

Treatments for Aqueous-deficient Dry Eye

 

Artificial tears are a mainstay in Dr. Croley’s treatment protocols as well, and when the main culprit is lack of tear production, in addition to Restasis, he suggests patients use an all-purpose-type tear, not necessarily one that targets the lipid layer. He may also use punctal plugs, either temporary collagen or permanent Herrick-style, and he says plugs designed to remain in place for 3 to 6 months are also available and may be useful for treating dry eye in patients who plan to schedule cataract surgery or LASIK. Dr. White adds that punctal plugs have improved over the years, thanks in part to “more effective, less invasive, less uncomfortable insertion techniques.”

 

To combat the inflammation that underlies dry eye, Dr. Croley also recommends HydroEye nutritional supplements (ScienceBased Health). “Along with other omega fatty acids and nutrients, HydroEye’s main ingredient is the fatty acid GLA, derived from black currant seed oil, which has been shown to increase production of prostaglandin E1, a potent anti-inflammatory chemical,”8 he says. A recent landmark multicenter, randomized, prospective, controlled study by John Sheppard and colleagues compared the effects of HydroEye to placebo in post-menopausal women.9 Only the supplements improved dry eye symptoms. In addition, the supplement group experienced no progression of ocular surface inflammation based upon conjunctival impression cytology T cell and HLA marker expression, while inflammation worsened in the placebo group. Corneal topographic smoothness was also maintained with supplement use, but surface irregularity progressed in the patients taking placebo.

 

Treatments for Evaporative Dry Eye

 

Nutritional supplements benefit patients with evaporative dry eye as well. “A recent revolution in the treatment of evaporative dry eye is the knowledge that we can provide extremely effective, long-term treatment for MGD by using high-quality Omega-3 fatty acids from marine sources, specifically fish oil,” Dr. White says. “In my opinion, Physician Recommended Nutraceuticals has done the best job of explaining and incorporating what we know about how the relative deficit of Omega-3s in the body in relation to levels of Omega-6s contributes to MGD.10 Its supplement designed for dry eye patients (Dry Eye Omega Benefits) contains a high concentration of the anti-inflammatory Omega-3 eicosapentaenoic acid (EPA), highly purified and in its natural triglyceride form, which maximizes absorption and minimizes side-effects. Lower quality fish oil supplements tend to cause GI tract side effects.”

 

Dr. White also says “the ‘rediscovery’ of loteprednol, specifically Lotemax (Bausch + Lomb), has been very helpful for patients with any type of moderate to severe dry eye. Furthermore, its safety profile allows doctors who really don’t focus on dry eye to be comfortable prescribing a steroid long-term.”

 

Dr. White highlights the off-label use of topical azithromycin as a “quiet revolution” in the treatment of MGD. “We can directly go after the inflammation in the glands, which seems to be controlled through the cytokine pathway. It turns out that azithromycin, formulated as AzaSite in particular11 (Akorn), has very powerful anti-inflammatory action in that pathway.12 Reducing inflammation in the gland improves the quality of the secretions and thus the functionality of artificial tears. Foulks12 examined gland secretions with infrared spectroscopy, which showed the properties of the lipid return to a more normal state with azithromycin treatment. Patients’ signs and symptoms of dry eye were relieved as well. This is a very good way to keep evaporative dry eye controlled with as few as two applications of the medication per week. This is an off-label use of azithromycin, but the studies to date and clinical experience have been very promising, and we know AzaSite is safe based on the clinical trials in which it was tested for the treatment of conjunctivitis.”

 

As mentioned previously, Dr. Croley counts LipiFlow as an important part of treatment for many of his patients with dry eye due to MGD. “Essentially, it unblocks or ‘cleans out’ the glands, allowing them to function normally so the quality of secretions improves, tear break-up time improves and patients are more comfortable,” he says. “I’ve been using the treatment for two years and so far no one has needed a repeat treatment.” Whether or not they receive a LipiFlow treatment, Dr. Croley recommends a maintenance treatment program for his evaporative dry eye patients, who account for 70-75% of his dry eye population. It consists of preservative-free Retaine MGD drops (Ocusoft), which are based on a proprietary nanoemulsion technology, hot compresses, Tranquileyes Moist Heat/Cold Therapy Goggles (eyeeco) and HydroEye supplements, potentially for a lifetime.

 

Cynthia Matossian, MD, Matossian Eye Associates in Hopewell and Hamilton, NJ, and Doylestown, Pa., has not brought LipiFlow into her practice, opting instead to incorporate intense pulsed light (IPL) therapy for patients with MGD who have not achieved adequate results with other treatments. “I’ve been using IPL for more than 3 years with great success,” she says. It was Rolando Toyos, MD, who first noticed that patients who were undergoing facial IPL treatment, which was originally developed to address irregular skin pigment, were also experiencing improvement in dry eye signs and symptoms. He re-engineered an existing IPL device to make it ideal for meibomian gland treatment (Quadra Q4 with DES, Derma- Med). Dr. Matossian explains IPL’s mechanism of action in dry eye: “The pulsed heat it delivers penetrates the dermis and closes off the abnormal blood vessels that are leaking proinflammatory mediators and adversely affecting the meibomian glands. The treatment is delivered across the entire lower lid from the tragus of one ear, across the bridge of the nose to the other ear tragus. I do two passes and then express the impacted meibum from the lower lids with a Q-tip. The entire process takes approximately 15 minutes. Over the course of four sessions, 4 to 5 weeks apart, I can clearly see the improvement, indicated by color and consistency, of the meibum.”

 

Concurrent with IPL treatment, Dr. Matossian has patients use a microwavable mask at home and take Omega-3 nutritional supplements, specifically Physician Recommended Nutraceuticals. “Not all Omega-3s are the same,” she says. “Some have been found to contain mercury and other contaminants.” Dr. Matossian also utilizes the Omega-3 Index test (OmegaQuant) which measures Omega-3 fatty acids EPA and docosahexaenoic acid (DHA) in the red blood cells. The test is done in-office with a finger prick. “If the test detects low levels, I know the patient isn’t taking the supplements as recommended, or perhaps is taking a lower-quality supplement, or we need to increase the dosage.”

 

Therapeutic Amniotic Membrane for Challenging Cases

 

At Virginia Eye Consultants, John Sheppard, MD, MMSC, sees more patients with severe signs and symptoms of dry eye than the average practice and increasingly relies on ProKera Slim (Bio-Tissue) to heal damaged and uncomfortable corneas. ProKera Slim is a biologic corneal bandage composed of cryopreserved amniotic membrane set in a polycarbonate ring and elastomeric band system. “Cryopreserved amniotic membrane is such a valuable adjunct in corneal disease therapy, OSD included,” he says. “I use it for patients who have severe signs and symptoms of dry eye, patients who have signs that worry me or symptoms that worry them, and for those who are not responding to first-line therapies, indicating we have to move forward with something better.”

 

ProKera Slim is inserted into the patient’s eye in-office and held in place by the eyelids. “I insert the device in the exam room, usually utilizing a lid speculum, with the patient in a horizontal position to prevent the membrane from falling onto the floor,” Dr. Sheppard says. “It is a patient- and doctor-friendly treatment with very little downside and a superior benefit-to-risk ratio. It induces a very rapid epithelial response.”

 

Bio-Tissue recently released preliminary results from a survey collecting doctor and patient feedback on the effectiveness of ProKera Slim for dry eye.13 Among patients who had responded at the time these results were released, 75% had been suffering from dry eye for three years or more. After treatment with ProKera Slim, 93% of respondents felt better. In addition, based on doctor feedback, 95% said the treatment healed their eye, and 81% said it improved their vision. Among respondents who previously experienced pain with dry eye, 89% said ProKera Slim alleviated the pain. Also among the early results: 81% of respondents said they would request ProKera Slim if their symptoms returned. “Cryopreserved amniotic membrane treatment has expanded from the OR to the outpatient clinic, and from corneal melts, neurotrophic epitheliopathy and infectious keratitis to more commonplace OSD, a truly remarkable adaptation,” noted Dr. Sheppard.

 

A New Era in OSD

 

Taking a moment to summarize his assessment of the dry eye landscape, Dr. Croley says “We have so much to talk about with dry eye patients, so I’m personally spending more office time with them. But these patients, especially in advanced cases, are looking for relief from severe discomfort, and the bottom line is — we are making people better.”

 

References

 

1. Chotikavanich S, de Paiva CS, Li DeQ, et al. Production and activity of matrix metalloproteinase-9 on the ocular surface increase in dysfunctional tear syndrome. Invest Ophthalmol Vis Sci Jul 2009; 50(7):3203-3209.

 

2. Sullivan BD, Whitmer D, Nichols KK, et al. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci 2010;51:6125-6130.

 

3. Schultz C. Safety and efficacy of cyclosporine in the treatment of chronic dry eye. Ophthalmol Eye Dis. 2014;6:37-42.

 

4. Nichols KK, Foulks GN, Bron AJ, et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci 2011;52:1922-1929.

 

5. Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction. Cornea 2012;31(4):396-404.

 

6. Foulks GN, Borchman D, Yappert M, et al.Topical azithromycin therapy of meibomian gland dysfunction: clinical response and lipid alterations. Cornea 2010;29(7):781-788.

 

7. Finis D, König C, Hayajneh J, et al. Implications of meibominan gland atrophy on the efficacy of Lipiflow treatment. Poster presentation 33-A002. Annual meeting of the Association for Research in Vision and Ophthalmology, May 4, 2014, Orlando, Fla.

 

8. Wu D, Meydani M, Leka L, et. al. Effect of dietary supplementation with black current seed oil on the immune response of healthy elderly subjects. Am J Clin Nutr 1999;70(4):536-543.

 

9. Sheppard JD, Singh R, McClellan AJ, et al. Long-term supplementation with n-6 and n-3 PUFAs improves moderate-to-severe keratoconjunctivitis sicca: a randomized double-blind clinical trial. Cornea 2013;32(10):1297-1304.

 

10. Miljanović B, Trivedi KA, Dana MR, et al. Relation between dietary n−3 and n−6 fatty acids and clinically diagnosed dry eye syndrome in women. Am J Clin Nutr 2005;82(4):887-893.

 

11. Luchs J. Azithromycin in DuraSite for the treatment of blepharitis. Clin Ophthalmol 2010;4: 681-688.

 

12. Foulks GN, Borchman D, Yappert M, Kakar S. Topical azithromycin and oral doxycycline therapy of meibomian gland dysfunction: a comparative clinical and spectroscopic pilot study. Cornea 2013;32(1):44-53. 13. Bio-Tissue Prokera Slim Dry Eye Study. Patient Survey Results. Internal data.

 

View the original article at Ophthalmology Management

 

Click to view the PDF

 

Written by Desiree Ifft, Contributing Editor of Opthalmology Management Magazine

 



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Outcomes of Intense Pulsed Light Therapy for Treatment of Evaporative Dry Eye Disease


Sunday, April 27, 2014: 1:11 PM

Room 150 (Boston Convention and Exhibition Center)

 

Preeya K. Gupta, MD, Duke Eye Center, Durham, NC, USA

Gargi K Vora, MD, Duke Eye Center, Durham, NC, USA

Sandra S. Stinnett, PhD, Duke University Medical Center, Durham, NC, USA

 

Purpose

 

To determine the clinical outcomes of IPL therapy for the treatment of evaporative Dry Eye Disease (DED).

 

Methods

 

A retrospective chart review was performed of 37 patients with a diagnosis of Dry Eye Syndrome that underwent IPL therapy from September 2012 through July 2013 at the Duke Eye Center. Demographics, clinical history, exam findings, and ocular surface disease index (OSDI) scoring data were collected from each visit. Data was analyzed using SAS analytical software.

 

Results

 

On average, patients underwent 4 IPL sessions. There was a significant decrease in scoring of lid margin edema, facial telangiectasia, lid margin vascularity, meibum quality, and OSDI score, all with p<0.001. There was a significant increase in oil flow score and tear break-up time, both p<0.001. No significant changes in intraocular pressure or acuity were noted.

 

Conclusion

 

IPL therapy for evaporative DED is a safe procedure. The objective clinical exam findings and subjective OSDI scoring data suggest that IPL is an effective treatment for patients with evaporative Dry Eye Disease.

 

Read more of the Outcomes of Intense Pulsed Light Therapy for Treatment of Evaporative Dry Eye Disease paper.

 



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New Device to Maintain IPL Dry Eye Treatment at Home


A new device has been created by Dr. Rolando Toyos for use at home, to maintain the effects of Intense Pulsed Light treatment for Dry Eye.

 

IPL as a treatment for meibomian gland dysfunction (MGD) – related Dry Eye was developed by Dr. Toyos and DermaMed Solutions, LLC.

 

IPL uses xenon light at a wavelength of 500 nm. The light penetrates into the dermal layer and closes the abnormal blood vessels that secrete inflammatory mediators.  The new home-use device uses a different wavelength in the 600 nm range, which is safe for patients to use at home.

 

“The treatment can be performed twice a week to stimulate the glands and better maintain the effect of IPL,” Toyos said, at the annual joint meeting of Ocular Surgery News and the Italian Society of Ophthalmology.

 

Read More at Healio Ophthalmology

  Toyos



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New Solutions for Dry Eye


For the more than 20 million Americans who suffer from chronic dry eye, blurred vision, irritation and redness of the eyes are daily burdens. For patients at Chu Vision Institute, intense pulsed light (IPL) therapy provides a simple solution for clearer, more comfortable vision.

 

We have been looking for a new treatment for chronic dry eye caused by meibomian gland dysfunction. As patients know, this can be a very frustrating condition. What’s so exciting about intense pulsed light therapy for dry eye, from the patient perspective, is that now they have a safe and effective alternative to the traditional medical therapies that have failed the patients.” — Y. Ralph Chu, M.D., Medical Director and founder of Chu Vision Institute and adjunct associate professor of ophthalmology at the University of Minnesota.

 

According to Y. Ralph Chu, M.D., Medical Director and founder of Chu Vision Institute and adjunct associate professor of ophthalmology at the University of Minnesota, chronic dry eye is one of the most common concerns patients present with at any ophthalmology practice. In the United States, about 6 million women and 3 million men have moderate or severe dry eye syndrome, and it is estimated that an additional 20 million to 30 million people have mild cases of dry eye syndrome. Symptoms include blurred vision, foreign body sensation and sensitivity to light. Because the symptoms can mimic other syndromes, chronic dry eye is often undiagnosed, which can lead to ocular complications such as cornea ulceration.

 

Understanding the Ocular Surface

 

As Dr. Chu explains, chronic dry eye was previously defined as a defect in the eye’s tear production. Now, the idea of quality of tears versus quantity of tears is finding a place in the condition’s diagnosis.

 

“Ophthalmologists have started classifying dry eye as ocular surface disease because we’ve learned that, really, dry eye is not just a lack of tears,” says Dr. Chu. “Many patients with adequate tear production also suffer from dry eye due to a poor quality tear film on the surface of the eye.”

 

A greater understanding of tears has led ophthalmologists to value the fluid — which is filled with proteins and electrolytes — as the underlying stabilizer of eye health that can minimize the symptoms of chronic dry eye. When the chemical makeup or production of tears becomes unbalanced, the disruption compromises the eye.

 

Serving as a key component to the tear balance, the meibomian glands secrete a fine layer of oil that keeps the water element of tears from evaporating. The glands, which are located at the base of the lashes on both the upper and lower eyelids, can become abnormal with age and certain conditions, such as ocular rosacea. In those cases, the secretions become thick and crystalline — like butter or toothpaste — when it should normally be smooth like olive oil. The change can initiate or worsen the symptoms of chronic dry eye.

 

In addition to understanding the role of tears and the supporting function of the meibomian glands, ophthalmologists clarified one of the fronts that can lead to an imbalance in tear quality.

 

“One of the key discoveries in the last several years is that we’ve learned dry eye is caused by inflammatory pathways,” says Dr. Chu. “Chronic, low-grade inflammation on the surface of the eye leads to damage to the surface, as well as the tissue that secretes the material that’s needed to keep the eye healthy.”

 

An Unexpected Side Effect

 

While RESTASIS, the only U.S. Food and Drug Administration-approved intraocular cyclosporine, is prescribed to reduce inflammation and prompt the natural production of tears, its integration into treatment plans did not solve the riddle of abnormal meibomian gland secretion. Around 2003, ophthalmologists began noticing that patients with chronic dry eye who received IPL therapy as a dermatologic treatment for rosacea were also experiencing a reduction in their dry eye symptoms.

 

Rolando Toyos, M.D., of Memphis, TN, was the first to quantify the relationship between IPL and chronic dry eye in several clinical studies. The final conclusion theorized that the treatment gently stimulated the meibomian gland, improving the quality of secretions and successfully decreasing the presence of telangiectasia.

 

Heating the Dryness Out

 

IPL therapy for dry eye is an effective outpatient treatment. Dr. Chu first cleans the face and places shields on both eyes to protect the lids and lashes. A cooling gel is applied to the eye area skin. Then, Dr. Chu passes the IPL handheld device across the skin, allowing the pulse of energy to heat the meibomian glands. The treatment also seals the delicate blood vessels at the lid.

 

“One of the pleasant side effects of this procedure is younger, healthier looking skin,” says Dr. Chu. “ It’s an element patients like that, besides improving their comfort and vision, can improve the look of their skin.”

 

The complete procedure typically lasts less than 15 minutes. Patients receive one treatment every month for four months. Typically, maintenance treatments are needed annually or semi-annually. Results can be seen after the initial treatment and can increase after each session.

 

To learn more about the Chu Vision Institute or to refer a patient, visit www.chuvision.com or call (952) 835-1235.

 

Original article by MD News

 

 



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Experimental Dry Eye Stimulates Production of Inflammatory Cytokines and MMP-9 and Activates MAPK Signaling Pathways on the Ocular Surface


Presented by:

Lihui Luo, De-Quan Li, Amish Doshi, William Farley, Rosa M. Corrales, and Stephen C. Pflugfelder

 

Purpose

 

To evaluate whether experimentally induced dry eye in mice activates mitogen-activated protein kinase (MAPK) signaling pathways, c-Jun N-terminal kinases (JNK), extracellular-regulated kinases (ERK), and p38 and stimulates ocular surface inflammation.

 

Methods

 

129SvEv/CD-1 mixed mice aged 6 to 8 weeks were treated with systemic scopolamine and exposure to an air draft for different lengths of time, from 4 hours to 10 days. Untreated mice were used as the control. The concentrations of IL-1β and TNF-α in tear fluid washings and in corneal and conjunctival epithelia were measured by ELISA. MMP-9 in tear washings was evaluated by zymography, and gelatinase activity in the cornea and conjunctiva was determined by in situ zymography. Corneal and conjunctival epithelia were lysed in RIPA buffer for Western blot with MAPK antibodies, or they were lysed in 4 M guanidium thiocyanate solution for extraction of total RNA, which was used to determine gene expression by semiquantitative RT-PCR, real-time PCR, and gene array.

 

Results

 

Compared with those in age-matched control subjects, the concentrations of IL-1β and MMP-9 in tear fluid washings and the concentrations of IL-1β and TNF-α and gelatinolytic activity in the corneal and conjunctival epithelia were significantly increased in mice receiving treatments to induce dry eye after 5 or 10 days. The expression of IL-1β, TNF-α, and MMP-9 mRNA by the corneal and conjunctival epithelia was also stimulated in mice treated for 5 or 10 days. The levels of phosphorylated JNK1/2, ERK1/2, and p38 MAPKs in the corneal and conjunctival epithelia were markedly increased as early as 4 hours after treatment, and they remained elevated up to 5 days.

 

Conclusions

 

Experimental dry eye stimulates expression and production of IL-1β, TNF-α, and MMP-9 and activates MAPK signaling pathways on the ocular surface. MAPKs are known to stimulate the production of inflammatory cytokines and MMPs, and they could play an important role in the induction of these factors that have been implicated in the pathogenesis of dry eye disease.

 

View the full article at IOVS

 

Click to view the PDF



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Intense Pulsed Light Skin Treatment Appears to Clear Meibomian Gland


Intense pulsed light treatment, long used for treating the skin condition rosacea, also may be effective for treating dry eye associated with meibomian gland dysfunction (MGD), according to studies by Rolando Toyos MD, Memphis, Tennessee, US. In his most recent study, presented at the XXVIII Congress of the ESCRS, Dr Toyos treated 15 patients with MGD and symptomatic dry eye who had a tear-film break-up time of less than six seconds. Patients received two to four treatments, depending on when symptoms improved. One month after the final IPL treatment, all eyes showed improved TBUT, averaging just over five seconds longer, ranging from three to 12 seconds longer.

 

Subjectively, all 15 patients also reported improvement in dry eye symptoms, with two reporting that one eye improved more than the other, Dr Toyos said. Typically, patients reported relief immediately following the final procedure as well as in the following weeks. Dr Toyos also observed reductions in objective MGD signs, including reduced lid telangectasia, fewer blocked meibomian glands and less-inflamed lid margins.

 

“Over the past eight years, we have improved the intense pulse light system, and have produced one that works well for the treatment of meibomian gland dysfunction,” said Dr Toyos, who is a consultant for DermaMed International (Lenni, Pennsylvania, US), which manufactures the IPL device.

 

Dr Toyos began investigating IPL treatment for dry eye in 2002 when he noticed that patients treated for rosacea often reported improvement in dry eye symptoms. In a 2006 contralateral eye study in 100 patients, he found the IPL-treated eyes had significantly longer TBUT after the third and fourth treatments. However, the effect was less than in the current study, possibly because it was an earlier device that was less effective in reaching the eyelid, he said.

 

IPL uses a filtered xenon source to expose skin to millisecond-length bursts of light in the 500 to 800 nm range, which is the peak absorption range for oxyhemoglobin and near peak for melanin. The light penetrates deeply into the papillary epidermis, reaching the abnormal blood vessels associated with both rosacea and MGD.

 

“When you flash this light at a blood vessel it is absorbed by blood cells and coagulates the blood vessel,” Dr Toyos explained. He believes the heat of photocoagulation also melts abnormal meibomian secretions, allowing them to be expressed with pressure, which unblocks the glands.

 

The immediate effect is like the most intense and effective warm compress these patients will ever get,” Dr Toyos said. Shutting off the blood vessels also may reduce the inflammatory mediators they secrete, which block the glands.

 

Dr Toyos is examining the possible impact of IPL on demodex mite infestations and bacteria on the eyelid. Some studies also suggest that IPL decreases interlukin-9, which has been associated with improved meibomian gland function. Other unknown factors may also be at play, and further study is needed to confirm the mechanism of action, he said.

 

Original article by Howard Larkin in Paris for ESCRS Eurotimes



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Grant Recipient Develops Treatment For Dry Eye


One of the ASCRS Foundation’s early research grant recipients, Dr. Rolando Toyos of Jackson Tennessee, has discovered a way to use intense pulsed light to treat the most common form of dry eye syndrome.

 

“It has been something that we have been working on since 2002. All of our hard work has paid off the last few years as we have perfected and standardized a way to treat patients with dry eye with IPL,” says Dr. Toyos.

 

Dry eye, a lack of sufficient moisture and lubrication in the eye, is one of the most commonly diagnosed ophthalmic conditions in the U.S. Some studies estimate it affects close to 10% of the population.

 

“The grant helped us tremendously,” adds Dr. Toyos who received his ASCRS grant in 2006 for his submission: The Use of Intense Pulse Light for the Treatment of Dry Eye Due to Meibomian Gland Dysfunction. Since beginning the research grant program, the Foundation has awarded over $300,000 in grants.

 

“I am very thankful for the opportunity that was given to me by the ASCRS Foundation. Also I am very glad that this idea actually worked and patients have been helped,” says Dr. Toyos.”

 

Original article by the ASCRS Foundation

 

Click to view the PDF

 



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Studies Confirm Efficacy of Intense Pulsed Light Treatment on Meibomian Gland Dysfunction


Intense pulsed light is an effective treatment for meibomian gland dysfunction and related dry eye disease, according to studies presented here.

 

Intense pulsed light (IPL, DermaMed) uses a xenon flashlight in a band between 400 nm and 1300 nm.

 

“Using a filter, we stabilize the emission at 500 nm wavelength, and it pulses on and off. The light penetrates the epidermis, goes down into the dermal layer, and it is absorbed by oxyhemoglobin in the blood cells, making oxyhemoglobin coagulate,” Rolando Toyos, MD, said at the annual joint meeting of Ocular Surgery News and the Italian Society of Ophthalmology.

 

IPL also generates heat that melts the thickened meibum secretions and dilates the glands. By applying gentle pressure, secretions are expressed from the gland, giving immediate comfort to the patient.

 

“Repeated IPL treatments make the secretions get thinner and thinner, because the telangiectasias that secrete the inflammatory mediators responsible for gland obstruction are closed,” Toyos said.

 

In a single-center prospective study of 30 patients with dry eye symptoms, a single IPL treatment was applied. A clinically significant decrease from abnormal to normal tear osmolarity was reported.

 

Another study looked retrospectively at the effects of repeated gland expression in 91 patients over 3 years.

 

“Over 90% of patients had improvement in their meibum and lid margin, and 93% of the patients reported satisfaction with improvement in dry eye symptoms,” Toyos said.

 

Complications such as temporary redness of the skin, conjunctival irritation, foreign body sensation, pain and light sensitivity for a few days were reported by 10 patients.

 

Original article by 



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ARVO Study – IPL as Treatment for Dry Eye Disease


A Retrospective Study of Effectiveness, Satisfaction and Adverse Effects

 

Presented by:
Rolando Toyos, MD, Toyos Clinic – Memphis, TN
William McGill, PhD, Monalco Research – Milwaukee, WI

 

MGD is the leading cause of evaporative DED. Patients who suffer from this disease produce an abnormal meibum that is more viscous than the usual olive oil like secretion. These patients can have severe inflammation and bacterial overgrowth that exacerbates the problem.

 

Most standard treatments such as anti-inflammatory drops or oral antibiotics aim at decreasing the inflammation associated with this disease. Others have used warm compresses in effort to melt the thick meibum produced by these patients. Finally, doctors have recommended lid scrubs to lower the bacterial load and cleanse the lid margin. Such treatments have been only somewhat effective for patients with MGD leading some to suggest a multi-faceted treatment approach.

 

Intense Pulsed Light has been used in Dermatology practices for several years as a treatment for Rosacea and acne. IPL uses a Xenon flashlamp to emit wavelengths of light from 400 to 1200 nanometers (nm). When placed on the light, a filter restricts the wavelength to the visible light range of around 500nm. When applied to the skin, this 500nm light causes the blood cells in the abnormal telangiectasias to absorb the light, coagulate and finally to close the blood vessels.

 

Objective

 

To describe clinical data concerning the effectiveness and safety of IPL skin treatment using the Toyos Technique as developed and refined over 6 years for patients with evaporative dry eye due to meibomian gland dysfunction.

 

Methods

 

A chart review was conducted for 123 patients with those targeted who presented with signs of severe dry eye as determined
by TBUT of <=5 seconds and who also had abnormal meibum and abnormal lid margin.

 

In all cases, study patients were persons who had reportedly tried or exhausted conventional DED treatments and actively
sought out the Toyos Clinic. These patients were driven to seek alternatives based on their subjective feelings of discomfort.
TBUT ranged from a low of 1 second to a high of 16 seconds.

 

All study patients were among those visiting a single clinic at least once over the 30-month of this study (May 2009 through
October 2011 outpatient clinic).

 

Data were available for 91 patients with 182 eyes who completed IPL and gland expression treatment for DED due to MGD.

 

Pre/post outcomes (total N=78) included change in TBUT. Additional post-treatment only dichotomous measures (N=91) were captured at end-of-treatment for change in lid margin and meibum (physician-determined yes/no) satisfaction with symptom change (patient-reported yes/no), and adverse events (patient reported or physician determined yes/no).

 

Results

 

91 patients with 182 eyes presented with severe DED based, in most cases, on a combination of TBUT, abnormal meibum, abnormal lid margin and patient discomfort.

 

Overall, a statistically significant mean improvement was found (paired T-test; p=.000) in TBUT from initial to end-oftreatment (4.4 OD, 4.8 OS). Using TBUT severity parameters developed by Doyle et al (2006), the average patient was severe (<=5 seconds) at start of treatment (mean TBUT=2.8 OD, 2.4 OS) improving to ‘moderate’ (<=10 seconds) by end-of-treatment (mean TBUT=7.2 OD, 7.2 OS).

 

Mean differences in pre/post TBUT by paired T-test were evaluated further for gender and by age quartiles. Statistically significant differences in overall TBUT were found for both gender and across age quartiles.

 

The average number of total treatments was 7 (median). The average number of maintenance treatments was 4 (median).

 

Considering individual differences from start to end-of-treatment, 86% of the 78 patients with pre/post TBUT times improved in both eyes, 9% remained the same in one or both eyes, and 5% worsened in one. No patient worsened in both eyes.

 

 

Pre-treatment view from one patient
presenting with abnormal lid margin
and DED symptoms

 

Post-treatment view from the same
patient presenting with abnormal lid
margin and DED symptoms

 

Other Metrics

 

Over 90% of all respondents appeared to improve across three metrics (94% meibum, 98% lid magin, 93% satisfaction). No patient failed to improve on at least one of the metrics.93% of patients reported satisfaction with the improvement in their DED symptoms (N=88).

 

Adverse Effects

 

Of the 91 patients, 13 (14%) experienced adverse events:
• Redness
• Broken blood vessels
• Cheek swelling
• Conjunctival cyst
• Light sensitivity for a few days
• Hair loss at brow and forehead

Of the 13 patients, 2 (15%) terminated their treatment.

 

Discussion

 

The leading cause of MGD is evaporative DED—a disease in which meibum production is more viscous than usual and from which patients can experience severe inflammation and bacterial overgrowth that exacerbates abnormal meibum production. Usual treatments have ranged from warm compresses to lid scrubs with mild cases proving easier to treat than moderate and especially severe cases.

 

Partly serendipitous, the value of IPL for treatment of DED was first identified by Dr. Toyos in 2002 when patients with DED—being treated for Rosacea, acne or other skin problems reported improvements in their dry eye symptoms. Following these and other early observations, modifications to the study treatment technique were made including the eventual development of an IPL device (the DermaMed Solutions Diamond Series Quadra Q4) specifically aimed at the treatment of DED due to MGD (and adjustable to differences in individual skin types).

 

TBUT: Pre/post effectiveness of treatment Of 78 patients for whom pre/ post measures of TBUT were available, statistically significant gains were found from 3.0 to 7.2 (mean difference 4.2, OD) and 2.6 to 7.0 (mean difference 4.4, OS). In effect, these changes reflect a shift from severe to moderate TBUT (DEWS, 2007). This shift is key.

 

Moderate and especially mild DED has been shown to be more amenable to the usual treatments, while severe DED has proven more difficult to treat. That the study treatment technique appears to be effective with those suffering severe dry eye is most promising. Because the majority of patients presented with initial TBUT of 5 seconds or less, the effectiveness of the Toyos method for moderate or mild cases of DED was not formally evaluated but should be in the future.

 

Over 93% of all respondents indicated satisfaction with treatment. Of 91 patients, 13 (14%) experienced an adverse event with just 15% (2 of 13) terminating treatment. Adverse events included redness, burst blood vessels, cheek swelling, conjunctival cyst, floaters, hair loss at brow and forehead, light sensitivity, and redness of face. In most cases, adverse effects such as swelling self-resolved within one week.

 

 
  DermaMed Solutions Diamond Series Quadra Q4 IPL

 

Demographics 

 

Demographic differences in responsiveness to treatment were null. While differences in the range of demographic groups
should be considered. A larger study population for all demographic groups should be considered. 

 

Limitations 

 

Limitations of the study include the following:
• No comparison group exists in which DED patients were directly evaluated for their responsiveness to alternative treatments.
• Patient satisfaction was measured post-study only and as ‘yes/no’. measurement.
• The physician who is both the developer of the study treatment technique and the evaluator of its effectiveness. Independent evaluation is warranted. 

 

All told, the results suggest that IPL holds promise as an option for treatment of evaporative DED due to MGD with a limited adverse event profile. A larger sample size with comparison group and random assignment to treatment would be helpful for better assessing both effectiveness of the study treatment technique as well as determining the range and frequency of adverse events. A rigorous multi-site prospective study is currently under development.

 

Click to view the ARVO Retrospective Study PDF



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