Greiner 2011

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 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

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

Purpose & Methods Evaluate the effectiveness of a single 12minute 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

Meibomian Gland Secretion Quality Score Five meibomian glands were evaluated for each of 3 sections of the lower eyelid (temporal, central, and nasal).

Lower Punctum

5 consecutive temporal glands

5 consecutive central glands

5 consecutive nasal glands

The meibomian gland evaluator1 Nose

Lower Eyelid Margin

1Korb

GRADE

SECRETION CHARACTERISTICS

0

Clear liquid secretion

1

Cloudy liquid secretion

2

Inspissated solid secretion (toothpaste consistency)

3

No secretion

and Blackie 2008

Lipiflow Treatment A single 12-minute automated LipiFlow treatment was performed.

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

Therapeutic Goal of Heat & Pulsatile Pressure Heat: Liquefy MG contents Facilitates evacuation of MG contents Pulsatile Pressure: Transiently ďƒŞ blood flow to the tissue thus ďƒŠ heat transfer efficiency Evacuate heated and liquefied MG contents to alleviate obstructions Combination: to create significantly less pain/discomfort compared with manual expression.

Lid Warmer Applies directional heat to inner eyelid

Eye Cup Applies intermittent pressure to outer eyelid

Insulated scleral shell shields eye from heat and vaults above the cornea preventing corneal contact

Inflatable air bladder Heat facilitates evacuation of obstructed meibomian glands

8

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

Mean OSDI Score (Max=100)

OSDI Scores Baseline to 12 months OSDI improved significantly from pre-treatment to 1 month. This improvement was maintained at 9 and 12 months. ANOVA, p < 0.0001

Pre-Tx

1 month

9 months

12 months

n = 21

n = 21

n = 21

n = 18

Mean

23.4

10.9

12.4

12.4

SD

14.6

13.2

15.5

14.6

Mean SPEED Score (max=28)

SPEED Scores Baseline to 12 months SPEED scores improved significantly from pretreatment to 1 month. This improvement was maintained at 9 and 12 months. ANOVA, p < 0.0001

Pre-Tx

1 month

9 months

12 months

n = 21

n = 21

n = 21

n = 18

Mean

12.9

6.3

6.2

6.3

SD

3.8

5.4

7.2

5.5

Mean TBUT (seconds)

Tear Break-Up Time (TBUT) Baseline to 12 months

TBUT improved significantly from pre-treatment to1 month. This improvement was maintained at 9 and 12 months. ANOVA, p < 0.005

Pre-Tx

1 month

9 months

12 months

n = 21

n = 21

n = 21

n = 18

Mean

4.6

8.7

6.8

7.1

SD

2.8

6.7

5.2

4.2

Mean MG Secretion Score (max=45)

Meibomian Gland Secretion Scores Baseline to 12 months

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-Tx

1 month

9 months

12 months

n = 21

n = 21

n = 21

n = 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 12minute 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