Managing MGD with thermal pulsation

June 1, 2014

A thermal pulsation system can safely and effectively treat meibomian gland obstructions in both the upper and lower eyelids simultaneously during an in-office procedure that takes only 12 minutes.

 

Take-home

A thermal pulsation system can safely and effectively treat meibomian gland obstructions in both the upper and lower eyelids simultaneously during an in-office procedure that takes only 12 minutes.

Dr. Rowen

By Liz Meszaros; Reviewed by Sheri Rowen, MD, FACS

Baltimore-In the battle against meibomian gland dysfunction (MGD)-the most common cause of dry eye-a therapeutic device (LipiFlow Thermal Pulsation System, TearScience) may be a safe, effective treatment, according to Sheri Rowen, MD, FACS.

She reviewed the standard of care for treatment of MGD and presented some of the results from an FDA clinical trial of the therapeutic device.

Recently, a paradigm shift has occurred in the way clinicians view dry eye disease, said Dr. Rowen, clinical assistant professor, University of Maryland, and director, Mercy Medical Center Department of Ophthalmology, Baltimore.

Dry eye is currently defined as “. . . a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.”1

“Evaporative disease is a major contributor, even over aqueous insufficiency, as a cause of dry eye syndrome (up to 87%),” Dr. Rowen said. “We need to address the lids/lipid layer as a key component for treatment. We have to treat the lids directly, and cannot leave it up to the patient.”

 

Intense pulsed light treatment

Intense pulsed light treatment (IPL)-currently used to treat rosacea and inflammatory lid disease-may now be another alternative for dry eye treatment. IPL treats rosacea and the inflammatory components of blood vessels and heats the lid and glands and decreases blood vessels.

This therapy can be very effective, but it can be uncomfortable and requires multiple sessions to evacuate the glands, Dr. Rosen noted.

“By performing IPL, I finally saw the poor quality and consistency of gland contents, which convinced me that lid disease had to be directly treated by us,” she said.

 

Another alternative

MGD is defined as “. . . a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative and quantitative changes in the glandular secretion. It may result in alteration of the tear film, eye irritation, clinically apparent inflammation, and ocular surface disease,” according to the International Workshop on Meibomian Gland Dysfunction: Executive Summary.2

Current therapies for MGD include warm compresses, eyelid scrubs, manual gland expression, and gland probing. The challenges of these therapies include the inadequacy of external heat application, significant discomfort for the patient, limited compliance by the patient, and the ability to treat only the upper glands.

“We have known about warm compresses and gland expression for years, but have not had the proper means to treat this,” Dr. Rowen said. “Most patients are incapable of treating their own lids, as we know, so we need to do it for them.

“[The thermal pulsation system] is a concept whose time has come,” she added. “It is a natural, safe, and comfortable way to treat MGD today.”

The thermal pulsation system can safely and effectively treat meibomian gland obstructions in both the upper and lower eyelids simultaneously during an in-office procedure that takes only 12 minutes.

The system utilizes heat and pressure in the form of thermal pulsation to liquefy and evacuate obstructed glands. The sterile disposable eyepiece connects to a console to control the application of heat and pressure to the eyelids. The eyepiece has a lid warmer that features a heater, eye insulation, and a vaulted shape, as well as an activator composed of an inflatable air bladder and a rigid activator.

 

Study results

Dr. Rowen presented data from an open-label crossover study in 278 eyes in 139 patients on a single 12-minute treatment with the system compared with 2-week daily warm compress therapy for MGD.

At baseline, patients treated with the device (n = 130) had a total meibomian gland score (0 to 45) of 6.3, compared with 14.3 at week 2, and with 16.7 (n = 125) at week 4. Patients treated with warm compresses daily (n = 136) had a baseline total meibomian gland score of 5.6, compared with 6.1 at week 2, and 11.7 at week 4 after crossover to the therapeutic system (n = 132) at week 2.

Mean standard patient evaluation of eye dryness (SPEED) questionnaire scores were also significantly improved in the therapeutic device group from baseline to week 4 (14.3 versus 7.6). The therapeutic device group had statistically significant greater improvement in the number of meibomian glands secreting clear liquid compared with warm compress control therapy.

Similar improvements in effectiveness trends were seen in patients crossed over from warm compress therapy to the therapeutic treatment. Mean improvement was observed with the therapeutic system from baseline to post-treatment in meibomian gland score, tear film breakup time, and SPEED and OSDI Dry Eye symptom questionnaires.

The overall safety profile of the system reflects a low incidence of non-serious, transient side effects, with no serious adverse events related to the device.

 

References

1.     Lemp MA, et al. The definition and classification of dry eye disease: Report of the Definition and Classification Subcommittee of the International Dry Eye Workshop (2007). Ocul Surf 2007;5:75-92.

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

 

Sheri Rowen, MD, FACS

P: 410/332-9500

E: srowen10gmail.com

Dr. Rowen has financial interests with Ace Vision Group, Alcon Laboratories, Allergan, Bausch + Lomb, PRN, and TearScience.