Purpose:
To evaluate the effect of a single treatment with the LipiFlow(®) Thermal Pulsation System on signs of meibomian gland dysfunction (MGD) and dry eye symptoms over a 9-month period.

Methods:
Patients (n = 42 eyes, 21 subjects) diagnosed with MGD and dry eye symptoms were recruited for a non-significant risk, prospective, open-label, 1-month clinical trial. Patients received a single 12-minute treatment using the LipiFlow(®) Thermal Pulsation System on each eye. The LipiFlow(®) device applies heat to the conjunctival surfaces of the upper and lower inner eyelids while simultaneously applying pulsatile pressure to the outer eyelid surfaces to express the meibomian glands. Patient symptoms were evaluated using the Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation for Eye Dryness (SPEED) dry eye questionnaires; tear break-up time was measured with the dry eye test (DET™); and meibomian gland function was evaluated using a standardized diagnostic expression technique. Data are presented for patient's pre-treatment (baseline) and at 1-month and 9-month post-treatment.

Results:
Meibomian gland secretion scores improved significantly from baseline (4.4 ± 4.0) to 1-month post-treatment (11.3 ± 6.2; p < 0.0001) and this improvement was maintained with no significant regression at 9 months (11.7 ± 5.9). Similarly, baseline tear break-up time (4.8 ± 3.2) was significantly increased at 1 month (9.6 ± 7.6; p < 0.001) and this increase was maintained with no significant regression at 9 months (7.1 ± 5.6). Symptom scores on both OSDI and SPEED questionnaires improved significantly at 1 month (p < 0.0001) and this improvement was maintained at 9 months.

Conclusion:
With such prolonged improvement in signs and symptoms of dry eye disease, the LipiFlow(®) Thermal Pulsation System offers a technological advancement for the treatment of dry eye disease secondary to meibomian gland dysfunction. A single 12-minute LipiFlow(®) treatment results in up to 9 months of sustained improvement of meibomian gland function, tear break-up time and dry eye symptoms that are unparalleled with current dry eye treatments.

Curr Eye Res. 2012 Feb 10. [Epub ahead of print]
Greiner JV.
Source
Schepens Eye Research Institute and the Department of Ophthalmology , Harvard Medical School, Boston, MA , USA.

Rebecca

July 8, 2011

Device news: Lipiflow

Rebecca

July 8, 2011

TearScience's Lipiflow is all the rage right now and for good reason. We have several people on the board who have undergone the procedure either in Europe, Canada or as part of a clinical trial in the US (where it is not yet approved) Thus far it is available in Toronto and in Abbotsford BC.

YouTube news video on Lipiflow at Herzig Eye in Toronto

June 9 press release:
TearScience Launches Breakthrough Technology in Canada to Address the Root Cause of Evaporative Dry Eye
TearScience Introduces LipiView® and LipiFlow® Devices at Canadian Ophthalmic Society Exhibition

MORRISVILE, N.C.--(BUSINESS WIRE)--TearScience, Inc., a privately-held medical device company, today announced the product launch of its LipiView® Ocular Surface Interferometer and LipiFlow® Thermal Pulsation medical devices in Canada. TearScience’s devices were designed to help eye care physicians address a root cause of evaporative dry eye, Meibomian Gland Dysfunction (MGD), which results in a lipid deficiency of the eye’s natural tear film. LipiView® helps physicians visualize the eye’s natural tear film. LipiFlow® is designed to alleviate meibomian gland obstructions by applying a precise combination of directed energy to eyelids during a 12 minute in-office treatment.

“Our goal is to help physicians make a meaningful difference for those who suffer from chronic evaporative dry eye.”
TearScience will demonstrate its devices at the Canadian Ophthalmic Society (COS) exhibition on June 9-12, 2011 at the Westin Bayshore Hotel in Vancouver at booth #28.

“TearScience is introducing a revolutionary technology as a new alternative to traditional treatments for Meibomian Gland Dysfunction,” said Jeff O’Hara, vice president of sales for TearScience. “Our goal is to help physicians make a meaningful difference for those who suffer from chronic evaporative dry eye.”

Herzig Eye Institute of Toronto is one of the first eye care practices in North America to implement TearScience’s system and has begun treating patients over the last several months.

Of the more than 100 million dry eye sufferers worldwide, approximately 65 percent have evaporative dry eye. Common symptoms of the disease include eye irritation, dryness, redness, tiredness, and visual disturbances.

In a randomized, controlled, multi-center clinical trial involving 139 patients, which compared the LipiFlow® System to iHeat™ warm compresses therapy for the treatment of Meibomian Gland Dysfunction, the total meibomian gland secretion score improved in 90 percent of patients at 4 weeks. Additionally, dry eye symptoms were improved from before the LipiFlow® treatment in 84-88 percent of patients at four weeks based on two different recognized symptom questionnaires, Standard Patient Evaluation of Eye Dryness (SPEED) and Ocular Surface Disease Index (OSDI).

TearScience will sell its LipiView® and LipiFlow® devices as a system to eye care practices. LipiView® recently won the Medical Design of Excellence Award from UBM Canon.

Rebecca

July 14, 2009

Abstract: Lipid layer thickness & dry eye symptoms

Rebecca

July 14, 2009

The Relationship Between Dry Eye Symptoms and Lipid Layer Thickness.
Cornea. 2009 Jul 1. [Epub ahead of print]
Blackie CA, Solomon JD, Scaffidi RC, Greiner JV, Lemp MA, Korb DR.

PURPOSE:: (1) To investigate the relationship between dry eye symptoms and lipid layer thickness (LLT) in patients presenting for routine eye examination and (2) to consider the practicality of interferometry in a clinical practice.

METHODS:: Patients presenting consecutively for routine eye examinations were recruited (n = 137, age range = 18-60 years, mean = 41.7 +/- 15.5 years, 102 females and 35 males). Patients were required to complete the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire after which their LLT was evaluated using a new interferometer (Ocular Surface Interferometer). Patients were assigned to 1 of 3 symptom categories: no symptoms (SPEED = 0), mild to moderate symptoms (SPEED = 1-9), and severe symptoms (SPEED >/= 10). Categorical analysis (contingency table) and linear regression were performed on the data.

RESULTS:: For patients with severe dry eye symptoms, 74% had an LLT /=75 nm (contingency table, chi = 12.63, df = 2, p = 0.0018). Furthermore, a linear regression of LLT and SPEED score reveal a significant linear relationship (as LLT increases, SPEED score decreases; p = 0.0014).

CONCLUSIONS:: (1) The data indicate that approximately 3 of 4 patients reporting severe symptoms have relatively thin lipid layers of 60 nm or less, whereas approximately 3 of 4 patients without symptoms have relatively thick lipid layers of 75 nm or more. Thus, the presence of dry eye symptoms significantly increases the likelihood of a relatively thin lipid layer. LLT seems to correlate better to symptoms, especially severe symptoms, than other reported correlations with objective clinical tests for dry eye disease. (2) Interferometry has the potential to be a practical and useful addition to clinical practice.