Transcript Effect of a Single Thermal Pulsation Treatment on Clinical Signs

Delay in Symptom Resolution After
Thermal Pulsation System Treatment for
Meibomian Gland Dysfunction in Dry-Eye
Disease
Jack V. Greiner, M.S., D.O., Ph.D.
Paula J. Oliver, A.S.
Mikhail Salganik, Ph.D.
The Schepens Eye Research Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
The Boston Ocular Surface Center
E-mail: [email protected]
None of the Authors have a Financial Interest to Disclose
Delay in Symptom Resolution After
Treatment of Dry Eye Diseases Secondary to
Meibomian Gland Dysfunction (MGD)
Simultaneous warming of the meibomian glands
and meibomian gland expression accomplished by
the non-pharmacologic technology of the LipiFlow
thermal pulsation system (LTPS) treatment
results in a more prompt improvement in
meibomian gland dysfunction (MGD) and dry eye
symptoms (e.g. ≤ 1month1-3), 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
Treatment of Dry Eye Disease Secondary to
Meibomian Gland Dysfunction (MGD)
In some cases, however, it was noted that the
significant improvement in meibomian gland
secretion (MGS) score at 1 month post-LTPS
treatment was not associated with a corresponding
improvement in symptoms as might have been
expected.
The basis of this disconnect between improvement
in signs and symptoms is unclear.
Purpose
To explore this variability in the time-line of
improvement in signs and symptoms of dry eye
disease secondary to MGD after a single 12-minute
thermal pulsation system (LTPS) treatment.
Methods
LTPS treatment was conducted on moderate to
severe MGD patients (n=68) in a prospective,
single-center, open-label randomized clinical trial.
Inclusion criteria required a validated Standard
Patient Evaluation for Eye Dryness (SPEED)
questionnaire score of ≥6 and meibomian gland
secretion (MGS) score of ≤20.
Signs and Symptoms Evaluated
Signs were measured using tear film breakup time
(TFBUT) and MGS scores at Baseline pre-LTPS
and at 1 and 3 months post-LTPS.
Symptoms were measured using SPEED and
Ocular Surface Disease Index (OSDI)
questionnaire scores at Baseline pre-LTPS and 1
and 3 months post-LTPS.
Tear Film Break-up Time
Tear film break-up time (TFBUT) was measured 3
consecutive times using a stop-watch (sec)
following instillation of fluorescein using the DET
test1,2 at 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.
Standardization of the Meibomian
Gland Secretion Score
Five meibomian glands are 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
Nose
Lower Eyelid Margin
Meibomian Gland Secretion Score to
Determine Severity & Monitor Treatment
Considering the grading scale the maximum
possible number of meibomian glands yielding
liquid secretion per eyelid =15, while the
maximum possible secretion quality score = 45.
GRADE
SECRETION CHARACTERISTICS
0
No secretion
1
Inspissated solid secretion (toothpaste consistency)
2
Cloudy liquid secretion
3
Clear 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
Validated Questionnaires
Ocular Surface Disease Index (OSDI)
Standard Patient Evaluation of Eye
Dryness (SPEED)
Measurement of Symptom Scores using
the SPEED Questionnaire
Symptoms were measured using the validated
SPEED questionnaire1,2 at Baseline 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.
Results
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.
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.
At 3 months, 3% (n=2) of these same patients
remained symptomatic based on SPEED and OSDI
questionnaire scores.
Conclusion
Symptomatic relief may lag behind clinicallyevident improvement in signs in a subset of
patients post-LTPS treatment, suggesting that a ≥3
month time point may be more informative when
evaluating the success of this procedure and
framing patients’ expectations prior to the
procedure itself.
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 factors that contribute to their
symptomatic experience that are not immediately
relieved by resolving the MGD.
Delay in Symptom Resolution after
Thermal Pulsation System Treatment for
Meibomian Gland Dysfunction in Dry-Eye
Disease
Jack V. Greiner, M.S., D.O., Ph.D.
Paula J. Oliver, A.S.
Mikhail Salganik, Ph.D.
The Schepens Eye Research Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
The Boston Ocular Surface Center
E-mail: [email protected]