By: Paul M. Karpecki, OD, FAAO Clinical Director – PECAA
I feel like the majority of questions I’ve received from PECAA members (email firstname.lastname@example.org) have been on in-office, patient pay procedures for ocular surface disease. Let’s visit that subject this month.
Eighty-six percent of patients with dry eye have evaporative dry eye (i.e. meibomian gland dysfunction (MGD) as a component of their condition).1 Many of these conditions won’t improve fully without some component of in-office therapy.
Newest to market: iLux
Tear Film Innovations recently launched a new in-office treatment for MGD called iLux. This small, cost-effective device has a handpiece with a detachable, disposable, sterile tip and a magnifying lens that allows better visualization of the blocked orifices and expressed meibum before and during the treatment. An LED-based heat source warms the inner and outer lids to a therapeutic temperature range; the clinician then applies compression, using a button on the handpiece, to express the melted meibum.
The iLux procedure can be customized to the patients’ needs by moving the tip to different locations on the upper and lower lids and adjusting the degree and duration of compression needed at each location. Most patients can be treated in less than 8 minutes. The handpiece, contains a lithium-ion battery that is recharged when it is placed in the charging cradle. To obtain FDA approval, the company conducted a randomized, open-label, multisite clinical trial comparing the iLux System to a predicate device. 142 patients were randomized between treatment options. Primary endpoints for signs were Meibomian Gland Score (MGS) and Tear Film Break-up Time (TFBUT) and for symptoms the Ocular Surface Disease Index (OSDI) questionnaire was utilized.
Overall, both treatments produced statistically and clinically significant improvements in the signs and symptoms of MGD meeting the criteria for approval. MG scores improved from a score of 5.6 glands producing liquid secretions prior to treatment to 23.6 at week four, TFBUT improved by more than 75% by week four, but both were statistically improved as soon as 2 weeks. Symptom scores improved dramatically on the OSDI from over 50 prior to treatment to about 20 by 2 weeks after treatment and improved further at 4 weeks.
In the pipeline: TearCare
Sight Sciences is developing an in-office treatment for MGD that is not yet commercially available. The TearCare System includes a single-use treatment kit that consists of four adhesive applicators that deliver heat (41°-45°C) to the external lids. The applicators are connected by a cable to a small, reusable handheld unit. Patients are instructed to blink normally during the 12-minute procedure to express meibum, and the clinician then uses expression forceps to further evacuate the glands. A prospective, randomized, pilot study demonstrated that the treatment had an immediate improvement on objective measures (TBUT, meibomian gland scores, and corneal and conjunctival staining) that was sustained through six months, while no such improvement was seen in the control group using daily at-home warm compresses with the washcloth bundle method.2
Well established: LipiFlow
The most established treatment for MGD, of course, is LipiFlow (Johnson & Johnson Vision). Available commercially for several years now, LipiFlow has many peer-reviewed papers in the literature to support its efficacy. It is a 12-minute, automated treatment that heats the inner eyelid, closest to the meibomian glands, and simultaneously massages the lids to evacuate gland contents. Several studies have reported sustained effects over 12 months or more following a single treatment including significant reductions in symptoms and improvements in MG secretions.3-5 There have also been reports of increased comfortable contact lens wear time of more than four hours following a single LipiFlow treatment.6
Tried and True at Home: The Bruder Mask
The Bruder Mask, with its patented MediBeads, is the only commercial hot compress to test above 42 degrees C on the back eyelid after use. A recent demo involving the beads of 5 other manufacturers of hot compresses showed that ONLY the Bruder mask could stand up to water. Meaning if you take the beads out of the other commercial masks and apply water, they crack, crackle, pop and disintegrate. There is no effect on the MediBeads in Bruder. Another study showed that the heat on the eye was exactly where the meibomian glands are located. The other masks showed heat primarily on the bridge of the nose and not one reached proper back of the eyelid temperatures. A recent study out of UAB showed that patients using the Bruder Mask once a day had a statistically significant improvement in contact lens wearing time compared to the bundled method (which is the only other method shown to work).
Mechanical debridement/scaling of the line of Marx and the lid margin removes keratin from the gland orifices. Korb and Blackie found that debridement, on its own, provided statistically significant symptom relief and improvement in meibomian gland function.7 The technique can have a synergistic effect when combined with other treatments that truly heat or express the glands.
Blepharoexfoliaion (Blephex) is a procedure the doctor or technician performs in-office to remove biofilm that contributes to MGD and dry eye blepharitis syndrome (DEBS), somewhat like a dentist removing plaque buildup on teeth. A spinning, disposable, medical-grade micro-sponge removes scurf and debris from the lid margin and lashes, exfoliating the eyelids. The brush cleans all four lids in 7-10 minutes (one disposable per eye). According to the DEBS theory, mechanical removal of biofilm from the lashes and lid margins may have a significant impact on Dry Eye Disease8, supporting other therapeutic interventions.
Intense pulsed light (IPL) systems have used by dermatologists for years to treat acne rosacea. Treatments are performed with 500- to 1200-nm light pulses for 20 to 30 minutes, and can be repeated every 4 to 5 weeks. Doctors with aesthetic practices noticed that treatment often seemed to improve dry eye symptoms and some began performing IPL for MGD. The theory is that high intensity light is absorbed by oxyhemoglobin, potentially reducing the amount of inflammatory mediators reaching the meibomian glands. Although preliminary results have shown some improvement in tear breakup time from IPL,9 it is not entirely clear which patients benefit most and whether IPL should be considered a primary or adjunctive treatment.
In-office treatment for MGD can be an important new revenue source for an optometric practice, as well as a great service for patients who are suffering from the symptoms of MGD and Dry Eye Disease. In addition, care of the lids and meibomian glands can help set your patients up for success when they are preparing for cataract or refractive surgery or experiencing decreased contact lens wearing time. This is a great time to evaluate available and pipeline treatments to determine how they might best fit into your practice.