lipiflow

Abstract: Lipiflow case report with MG dropout

I guess it's nice to have some hopeful reports like this to round out some of the less impressive results I've been hearing from some of the patients. What we'll all think of it 3 years down the road is anyone's guess at this point.

Case Report: A Successful LipiFlow Treatment of a Single Case of Meibomian Gland Dysfunction and Dropout.

OBJECTIVE:
The aim of this study was to investigate whether a single case of meibomian gland dysfunction (MGD), with significant MG dropout resulting in evaporative dry eye, could be effectively treated with the LipiFlow (a new Food and Drug Administration-approved thermodynamic pulsatile treatment).

MATERIALS AND METHODS:
A 39-year-old white woman experienced severe dry eye symptoms because of MGD with considerable MG dropout resulting in evaporative dry eye. Standardized diagnostic MG expression and meibography led to the tentative diagnosis of nonobvious MGD (only 1 functional MG on each lower lid) and MG dropout (∼50% of the lower lid MGs were missing with the remaining MGs being severely truncated). The patient underwent a single 12-min LipiFlow treatment per eye and returned for follow-up at 1 and 7 months posttreatment.

RESULTS:
The LipiFlow treatment increased the number of functional lower lid MGs from 1 to 5 glands OD and 1 to 7 glands OS at 1 month with slight regression at 7 months (4 OD and 4 OS); increased fluorescein break-up time from 4 to 7 sec OD and 4 to 9 sec OS at both 1 and 7 months; and decreased symptom scores by approximately 50% at 1 month and approximately 75% at 7 months.

CONCLUSIONS:
These results demonstrate the effectiveness of the LipiFlow in restoring MG function and improving ocular comfort even in this particular case of significant MG dropout and MG truncation.


Eye Contact Lens. 2012 Mar 12. [Epub ahead of print]
Korb DR, Blackie CA.
Source
Korb Associates (D.R.K., C.A.B.), Boston, MA; and TearScience Inc. (D.R.K., C.A.B.), Morrisville, NC.

Abstract: 9-month lipiflow effects

A Single LipiFlow(®) Thermal Pulsation System Treatment Improves Meibomian Gland Function and Reduces Dry Eye Symptoms for 9 Months.

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.

Speaking of Lipiflow...

Interesting article from last month mentions a few practical items that interested dry eye patients might want to know...

How TearScience’s dry eye treatment sparked a new FDA 510(k) strategy
(MedCity, Feb 7th)

One piece of the commercialization puzzle that TearScience has yet to solve is reimbursement. Insurers do not yet pay for LipiFlow treatment and though the company has applied to instate reimbursement, Willis estimates the entire process can take anywhere from three to 10 years. For now, patients pay between $1,400 and $1,900 out of pocket for a treatment on both eyes that lasts nine to 18 months. Willis said that considering that some people with moderate to severe dry eye are already spending up to $4,000 annually on other remedies, patients are willing to pay. For a physician’s practice, the entire TearScience diagnostic and treatment system costs about $100,0000.