Delay in Symptom Resolution Delay in Symptom Resolution After Thermal Pulsation System After Thermal Pulsation System Treatment for Meibomian Gland Treatment for Meibomian Gland Dysfunction in Dry-Eye DiseaseDysfunction in Dry-Eye Disease

Jack V. Greiner, M.S., D.O., Ph.D.Jack V. Greiner, M.S., D.O., Ph.D.Paula J. Oliver, A.S.Paula J. Oliver, A.S.

Mikhail Salganik, Ph.D.Mikhail Salganik, Ph.D.

The Schepens Eye Research InstituteMassachusetts Eye and Ear Infirmary

Harvard Medical SchoolThe Boston Ocular Surface Center

E-mail: Jack_Greiner@meei.harvard.edu

None of the Authors have a Financial Interest to Disclose

Delay in Symptom Resolution After Delay in Symptom Resolution After Treatment of Dry Eye Diseases Treatment of Dry Eye Diseases Secondary to Meibomian Gland Secondary to Meibomian Gland

Dysfunction (MGD)Dysfunction (MGD)

Simultaneous warming of the meibomian glands and meibomian Simultaneous warming of the meibomian glands and meibomian gland expression accomplished by the non-pharmacologic gland expression accomplished by the non-pharmacologic technology of the LipiFlow thermal pulsation system (LTPS) technology of the LipiFlow thermal pulsation system (LTPS) treatment results in a more prompt improvement in meibomian treatment results in a more prompt improvement in meibomian gland dysfunction (MGD) and dry eye symptoms (e.g. gland dysfunction (MGD) and dry eye symptoms (e.g. ≤ ≤ 1month1month1-1-

33), than the conventional use of these techniques individually.), than the conventional use of these techniques individually.

1Lane, Dubiner, Epstein, Ernest, Greiner: Cornea 2012;31(4):396-404. 2Greiner: Curr Eye Res 2012;37(4):272-278.3Greiner: J Clin Experiment Ophthalmol 2013;41:524-530.

Delay in Symptom Resolution After Delay in Symptom Resolution After Treatment of Dry Eye Disease Treatment of Dry Eye Disease

Secondary to Meibomian Gland Secondary to Meibomian Gland Dysfunction (MGD)Dysfunction (MGD)

In some cases, however, it was noted that the significant In some cases, however, it was noted that the significant improvement in meibomian gland secretion (MGS) score at 1 month improvement in meibomian gland secretion (MGS) score at 1 month post-LTPS treatment was not associated with a corresponding post-LTPS treatment was not associated with a corresponding improvement in symptoms as might have been expected. improvement in symptoms as might have been expected.

The basis of this disconnect between improvement in signs and The basis of this disconnect between improvement in signs and symptoms is unclear.symptoms is unclear.

PurposePurposeTo explore this variability in the time-line of To explore this variability in the time-line of improvement in signs and symptoms of dry improvement in signs and symptoms of dry eye disease secondary to MGD after a single eye disease secondary to MGD after a single 12-minute thermal pulsation system (LTPS) 12-minute thermal pulsation system (LTPS) treatment.treatment.

MethodsMethodsLTPS treatment was conducted on moderate to severe MGD LTPS treatment was conducted on moderate to severe MGD patients (n=68) in a prospective, single-center, open-label patients (n=68) in a prospective, single-center, open-label randomized clinical trial. randomized clinical trial.

Inclusion criteria required a validated Standard Patient Evaluation Inclusion criteria required a validated Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire score of for Eye Dryness (SPEED) questionnaire score of ≥≥6 and meibomian 6 and meibomian gland secretion (MGS) score of gland secretion (MGS) score of ≤≤20.20.

Signs and Symptoms Signs and Symptoms EvaluatedEvaluated

Signs were measured using tear film breakup time (TFBUT) Signs were measured using tear film breakup time (TFBUT) and MGS scores at Baseline pre-LTPS and at 1 and 3 months and MGS scores at Baseline pre-LTPS and at 1 and 3 months post-LTPS.post-LTPS.

Symptoms were measured using SPEED and Ocular Surface Symptoms were measured using SPEED and Ocular Surface Disease Index (OSDI) questionnaire scores at Baseline pre-Disease Index (OSDI) questionnaire scores at Baseline pre-LTPS and 1 and 3 months post-LTPS. LTPS and 1 and 3 months post-LTPS.

Tear Film Break-up TimeTear Film Break-up Time

Tear film break-up time (TFBUT) was measured 3 Tear film break-up time (TFBUT) was measured 3 consecutive times using a stop-watch (sec) following consecutive times using a stop-watch (sec) following instillation of fluorescein using the DET testinstillation of fluorescein using the DET test1,21,2 at at Baseline pre-LPST and 1 and 3 months post-LPST Baseline pre-LPST and 1 and 3 months post-LPST

1Korb, Greiner, Herman: Cornea 2001;20:811-815.2Abdul-Fattah, Bhargava, Korb, Glonek, Finnemore, Greiner: Optom Vis Sci 2002;79:435-438.

Meibomian Gland Secretion (MGS) Scores

These scores were obtained using a meibomian gland evaluator (MGE).

Meibomian Gland Evaluator (MGE)

MGE-mediated meibomian gland assessment is standardized1 by allowing quantification of the force used to diagnose meibomian gland obstruction and dysfunction.

The skin is applanated with the MGE with a constant force of approximately 1.2 gm/mm2 pressure.

1Horley DW, Korb DR: US Patent 3411364, November 19, 1968.

5 consecutive nasal glands

Nose

Gla

nd E

valu

ator

5 consecutive temporal glands

Lower Eyelid Margin

Lower Punctum

5 consecutive central glands

Standardization of the Meibomian Standardization of the Meibomian Gland Secretion ScoreGland Secretion Score

Five meibomian glands are evaluated for each of 3 sections of the lower eyelid (temporal, central, and nasal).

Meibomian Gland Secretion Score to Meibomian Gland Secretion Score to Determine Severity & Monitor Treatment Determine Severity & Monitor Treatment

Considering the grading scale the maximum possible number Considering the grading scale the maximum possible number of meibomian glands yielding liquid secretion per eyelid =15, of meibomian glands yielding liquid secretion per eyelid =15, while the maximum possible secretion quality score = 45.while the maximum possible secretion quality score = 45.

GRADEGRADE SECRETION CHARACTERISTICSSECRETION CHARACTERISTICS

00 No secretionNo secretion

11 Inspissated solid secretion (toothpaste consistency) Inspissated solid secretion (toothpaste consistency)

22 Cloudy liquid secretionCloudy liquid secretion

33 Clear liquid secretionClear liquid secretion

Grading Meibomian Gland Secretions

No Secretion [score 0]

Inspissated Solid Secretion (Toothpaste Consistency) [score 1]

Cloudy Liquid Secretion [score 2]

Clear Liquid Secretion [score 3]

Symptoms Analyzed by Two Symptoms Analyzed by Two Validated QuestionnairesValidated Questionnaires

Ocular Surface Disease Index (OSDI)Ocular Surface Disease Index (OSDI)

Standard Patient Evaluation of Eye Standard Patient Evaluation of Eye Dryness (SPEED)Dryness (SPEED)

Measurement of Symptom Scores Measurement of Symptom Scores using the SPEED Questionnaire using the SPEED Questionnaire

Symptoms were measured using the Symptoms were measured using the validated SPEED questionnairevalidated SPEED questionnaire1,21,2 at Baseline at Baseline pre-LPST) and 1 and 3 months post-LPST. pre-LPST) and 1 and 3 months post-LPST.

1Korb, Herman, Greiner et al: Eye Contact Lens 2005;31:2-8.2Ngo, Ping, Kier, et al: Cornea 2013:32:1204-1210.

Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire

Evaluates the frequency and severity of dry eye symptoms over the past 3 months.

A SPEED symptom score of ≥6 should be considered for treatment.

ResultsResultsAt both the 1 and 3 month time points, all 68 patients had improved signs of TFBUT (p<0.01) At both the 1 and 3 month time points, all 68 patients had improved signs of TFBUT (p<0.01) and MGS scores (p<0.001) compared to Baseline values.and MGS scores (p<0.001) compared to Baseline values.

At 1 month, 9% (n=6) of these same patients were still symptomatic as measured by SPEED At 1 month, 9% (n=6) of these same patients were still symptomatic as measured by SPEED (p<0.05) and OSDI (p<0.05) questionnaire scores.(p<0.05) and OSDI (p<0.05) questionnaire scores.

At 3 months, 3% (n=2) of these same patients remained symptomatic based on SPEED and At 3 months, 3% (n=2) of these same patients remained symptomatic based on SPEED and OSDI questionnaire scores.OSDI questionnaire scores.

ConclusionConclusionSymptomatic relief may lag behind clinically-evident improvement in signs in Symptomatic relief may lag behind clinically-evident improvement in signs in a subset of patients post-LTPS treatment, suggesting that a a subset of patients post-LTPS treatment, suggesting that a ≥≥3 month time 3 month time point may be more informative when evaluating the success of this procedure point may be more informative when evaluating the success of this procedure and framing patients’ expectations prior to the procedure itself.and framing patients’ expectations prior to the procedure itself.

This delay in symptomatic relief may be a reflection of the multifactorial This delay in symptomatic relief may be a reflection of the multifactorial nature of dry eye disease itself in that some patients may have multiple nature of dry eye disease itself in that some patients may have multiple factors that contribute to their symptomatic experience that are not factors that contribute to their symptomatic experience that are not immediately relieved by resolving the MGD. immediately relieved by resolving the MGD.

Delay in Symptom Resolution Delay in Symptom Resolution after Thermal Pulsation System after Thermal Pulsation System Treatment for Meibomian Gland Treatment for Meibomian Gland Dysfunction in Dry-Eye DiseaseDysfunction in Dry-Eye Disease

Jack V. Greiner, M.S., D.O., Ph.D.Jack V. Greiner, M.S., D.O., Ph.D.Paula J. Oliver, A.S.Paula J. Oliver, A.S.

Mikhail Salganik, Ph.D.Mikhail Salganik, Ph.D.

The Schepens Eye Research InstituteMassachusetts Eye and Ear Infirmary

Harvard Medical SchoolThe Boston Ocular Surface Center

E-mail: Jack_Greiner@meei.harvard.edu