Effect of a Single Thermal Pulsation

Treatment on Clinical Signs & Symptoms

of Meibomian Gland Dysfunction and Dry

Eye over 12 Months

Jack V. Greiner, M.S., D.O., Ph.D.

The Schepens Eye Research Institute,

Department of Ophthalmology, Harvard Medical School and

The Boston Ocular Surface Center

E-mail: greiner@schepens.harvard.edu

Normal Meibomian Glands

Orifices

express

clear lipid

Dry Eye

Meibomian gland dysfunction (MGD) maybe the leading cause of dry eye through out the world (TFOS 2008, 2010).

MGD relates to impaired efficacy of the secretion of the meibomian glands, compromising the role of the lipid layer for maintenance of the normal tear film and the prevention of dry eye.

Blackie et al. Nonobvious Obstructive

Meibomian Gland Dysfunction.

Cornea: E-Pub ICO201681

Purpose & Methods

Evaluate the effectiveness of a single 12-minute treatment with a novel thermal pulsation system: The LipiFlow

Patients with MGD and moderate to severe dry eye were recruited for a prospective, randomized, open-label, multi-center registered clinical trial.

Data represent a sub-cohort (n = 30): a single-center of the larger registered clinical trial1,2

1Greiner 2010, LipiFlow Study Group, 2Majmudar et al 2010, LipiFlow Study Group

Inclusion/ Exclusion Criteria

Inclusion Criteria:Subjects at least 18 yrs of age

MG obstruction using standardized assessment1 of 15 lower eyelid glands (MG secretion score ≤ 12)

Dry eye symptoms (SPEED2 score ≥ 6) OU

Exclusion Criteria:Ocular conditions increasing injury risk related to the

device procedure

Eyelid abnormalities affecting lid function

Co-existing ocular or systemic conditions that may limit the effectiveness of the device treatment

1Korb and Blackie 2008 2Standard Patient Evaluation of Eye Dryness (SPEED), Korb et al, 2005

5 consecutive

nasal glands

Nose

5 consecutive

temporal glands

Lower Eyelid Margin

Lower

Punctum

5 consecutive

central glands

Meibomian Gland Secretion Quality Score

Five meibomian glands were evaluated for each of 3

sections of the lower eyelid (temporal, central, and nasal).

GRADE SECRETION CHARACTERISTICS

0 Clear liquid secretion

1 Cloudy liquid secretion

2 Inspissated solid secretion (toothpaste consistency)

3 No secretion

The meibomian gland evaluator1

1Korb and Blackie 2008

Lipiflow Treatment

A single 12-minute automated LipiFlow treatment was performed.

Patient post-treatment follow-up was 1 day (safety) and at 4 wks, 9 mo, and 12 mo.

Therapeutic Goal of Heat &

Pulsatile PressureHeat:

Liquefy MG contents

Facilitates evacuation of MG

contents

Pulsatile Pressure:

Transiently blood flow to the

tissue thus heat transfer

efficiency

Evacuate heated and liquefied

MG contents to alleviate

obstructions

Combination: to create significantly

less pain/discomfort compared with

manual expression.

8

Eye Cup

Applies intermittent

pressure to outer

eyelid

Inflatable

air bladder

Insulated scleral

shell shields eye

from heat and

vaults above the

cornea preventing

corneal contact

Lid Warmer

Applies directional

heat to inner eyelid

Heat facilitates evacuation of

obstructed meibomian glands

Results

Symptom Scores: SPEED1 and OSDI2

scores

Tear break-up time

MG Secretion Score

Statistical analysis:ANOVA (with Bonferroni correction) was used to determine statistical significance at the level a = 0.05 (p<0.05 was considered significant)

1Korb et al 2005, Schiffman et al 2001

OSDI Scores

Baseline to 12 months

Pre-Txn = 21

1 monthn = 21

9 monthsn = 21

12 monthsn = 18

Mean 23.4 10.9 12.4 12.4

SD 14.6 13.2 15.5 14.6

Mea

n O

SDI S

core

(M

ax=1

00

)

OSDI improved significantly

from pre-treatment to 1

month. This improvement was

maintained at 9 and 12

months. ANOVA, p < 0.0001

SPEED Scores

Baseline to 12 months

Pre-Txn = 21

1 monthn = 21

9 monthsn = 21

12 monthsn = 18

Mean 12.9 6.3 6.2 6.3

SD 3.8 5.4 7.2 5.5

Mea

n S

PEE

D S

core

(m

ax=

28

)

SPEED scores improved

significantly from pre-

treatment to 1 month. This

improvement was maintained

at 9 and 12 months. ANOVA,

p < 0.0001

Tear Break-Up Time (TBUT)

Baseline to 12 months

Pre-Txn = 21

1 monthn = 21

9 monthsn = 21

12 monthsn = 18

Mean 4.6 8.7 6.8 7.1

SD 2.8 6.7 5.2 4.2

Mea

n T

BU

T (s

eco

nd

s)

TBUT improved significantly

from pre-treatment to1

month. This improvement

was maintained at 9 and 12

months. ANOVA, p < 0.005

Meibomian Gland Secretion Scores

Baseline to 12 months

Mea

n M

G S

ecre

tio

n S

core

(m

ax=4

5)

The meibomian gland secretion

score improved significantly

from pre-treatment to 1 month.

This improvement was

maintained at 9 and 12 months.

ANOVA, p < 0.0001

Pre-Txn = 21

1 monthn = 21

9 monthsn = 21

12 monthsn = 18

Mean 4.4 11.3 11.7 7.3

SD 3.7 4.5 4.4 4.6

Summary of Results

The single 12-min treatment with the LipiFlow was effective in significantly improving the mean meibomian gland function and TBUT over the 4-wk study duration and this trend continued for up to 12 mo.

The LipiFlow resulted in a statistically significant reduction in mean dry eye symptoms from baseline after LipiFlow treatment for up to 12 mo.

A single=12-min treatment with the LipiFlow provided sustained effectiveness over the 4-wk study duration and for up to 12 mo after the single treatment.

Conclusion

The simultaneous applications of regulated heat

and pressure applied to the inner surfaces of the

upper and lower eyelids was a highly effective

means of therapy for MGD and associated Dry

Eye signs, including MG function and TBUT, and

symptoms.

The effect lasted over the 4-week study duration

and for up to 12 months after the single 12-

minute LipiFlow treatment.

Effect of a Single Thermal Pulsation

Treatment on Clinical Signs & Symptoms of

Meibomian Gland Dysfunction and Dry Eye

over 12 Months

Jack V. Greiner, M.S., D.O., Ph.D.Schepens Eye Research Institute

Harvard Medical School

Boston Ocular Surface Center

E-mail: greiner@schepens.harvard.edu