Less than Perfect Outcomes - Cataract Surgery and Dry Eye Oct 2014

9/2/14
Less Than Perfect Outcomes After
Uneventful Cataract Surgery:
What Are We Missing?
!  I am a consultant for Allergan, Alcon,
B&L, and Tear Science
!  I have no financial interest in any
product discussed herein
Parag A. Majmudar, MD
Associate Professor of Ophthalmology
Rush University Medical Center
Chicago Cornea Consultants, Ltd.
Chicago, IL USA
Playing Detective
!  Most of our cataract patients
experience great outcomes following
modern cataract surgery
!  When they don’t, we need to solve the
mystery
!  One of the most common problems is
fortunately easy to remedy, and with
some planning - identify and treat preoperatively
What’s the most important refracting
surface of the eye?
!  Cornea?
!  Lens?
The Tear Film!
Image Courtesy of Marguerite McDonald, MD
Image Courtesy of Marguerite McDonald, MD
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9/2/14
P.H.A.C.O.:
Prospective Health Assessment of
Cataract patients Ocular surface
Objective:
•  To determine the prevalence of dry eye in patients undergoing cataract
surgery
Methods:
•  Prospective, multi-center study (10 sites)
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Tear Break up Time
!  What time is considered abnormal?
–  5 seconds?
–  7 seconds?
–  9 seconds?
Tear Break up
Mark Packer, MD
Damien Goldberg, MD
Parag Majmudar, MD
Eric Donnenfeld, MD
Marguerite McDonald, MD
Karl Stonecipher, MD
Jon Vukich, MD
Chaz Reilly, MD
Gregg Berdy, MD
Ranjan Malahotra, MD
William Trattler, MD
•  200 patients scheduled for cataract surgery
William Trattler, MD
Results:
Tear Break up Time
N = 102 patients (204 eyes)
!  Average TBUT: 4.93 seconds –  # of eyes with TBUT ≤ 5 seconds: 126 eyes (61.7%) –  # of eyes with TBUT ≤ 7 seconds: 169 eyes (82.8%) Corneal Staining
N = 102 patients (204 eyes scored)
!  PosiFve Corneal Staining: 154 eyes (75.5%) !  Central Corneal Staining: 92 eyes (45.1%) Central Corneal Staining Schirmer’s Scores
N = 102 patients (204 eyes)
!  Eyes with Schirmer’s score ≤ 10: 95 eyes (46.6%) !  Eyes with Schirmer’s score ≤ 5: 38 eyes (18.6%) Summary of PHACO Study
(Patients scheduled for cataract
Surgery)
!  Dry eye signs are very common in paFents scheduled for cataract surgery –  TBUT: •  More than 60% with very abnormal TBUT (≤ 5 seconds) –  83% with TBUT ≤ 7 seconds –  Corneal Staining •  45% with Central staining –  Schirmer’s score
•  18.6% with very low Schirmer’s (≤5mm) William Trattler, MD
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9/2/14
Topography: Excellent Tool
for Diagnosing a Poor Tear Film
Recommenda;ons for all cataract surgery pa;ents: Preop Topography
Dry Spots
58 year old male with visually significant cataract OS, interested in a premium IOL. William Trattler, MD
Preop Topo after 1 day of Treatment
William Trattler, MD
Preop Topo after one week of Treatment
.
Same paFent : 1 day aZer starFng lubricaFng drops. William Trattler, MD
Same paFent: one week aZer iniFaFng topical steroids along with lubricaFng drops William Trattler, MD
Dry Eye Identified:
One week after cyclosporine BID
Preop Evaluation
60 year old male: Initial
Consultation for Presbyopic IOL
William Trattler, MD
William Trattler, MD
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9/2/14
Summary
!  Dry eye is very common in patients planning
cataract surgery
–  More than 60% with very abnormal TBUT
–  50% with Central staining
–  21% with very low Schirmer’s (≤5mm)
!  Preop testing can identify less than ideal
candidates for Presbyopic IOLs
–  Topography
–  OCT of the macula
–  Fluorescein staining of the cornea:
The Ocular Surface:
Role in Vision Quality
!   Vision quality
depends in large part
to a healthy ocular
surface and tear film
!   The most advanced
wavefront-guided
laser refractive
procedure or the
latest generation
presbyopia-correcting
IOL is meaningless in
the setting of a
dysfunctional ocular
surface
•  Dry Eye
•  EBMD
William Trattler, MD
The Normal Tear Film:
A Delicate Balance
!   Lipid, Aqueous and Mucin
components
!   Lipid layer (from
Meibomian glands)
retards aqueous
evaporation
!   Aqueous layer: mixture of
proteins, mucins,
electrolytes
Meibomian Gland Dysfunction:
A Prevalent Condition with
Consequences
“Meibomian gland dysfunction (MGD) may
well be the leading cause of dry eye
disease throughout the world.”1
—The International Workshop on Meibomian Gland Dysfunction:
Executive Summary
–  Secreted by lacrimal glands
Image from Dry Eye and Ocular Surface Disorders, 2004
!   Mucins provide viscosity
and stability during blink
cycle
MGD: Toothpaste
1.  Nichols KK, et al. The international workshop on meibomian gland dysfunction: executive
summary.
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Invest Ophthalmol Vis Sci. 2011;52(4):1922-1929.
2.  Lemp MA, Nichols KK. Blepharitis in the United States 2009: a survey-based perspective on
prevalence and treatment. Ocul Surf. 2009;7(2 Suppl):S1-S14.
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Treatment of
Tear Film Disorders
!  Physical Measures:
–  Hot compresses/lid massage
!  Nutritional Supplements
–  Flaxseed oil, essential fatty acids
!  Pharmaceutical Measures:
–  Lipid-altering substances (doxycycline)
•  Inhibition of MMPs
Image Courtesy of Gary N. Foulks, MD
!  Corticosteroids
!  Antibiotics: azalides (Azasite)
!  Cyclosporine A (topical, Restasis)
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9/2/14
LipiFlow® Thermal Pulsation
System
LipiFlow® Thermal
Pulsation System
!   Heat applied to the
palpebral surfaces of
the upper and lower
eyelids directly over
the meibomian glands
The Lid Warmer:
Comprised of a precision
heater, eye insulation &
vaulted shape
!   Graded pulsatile
pressure delivered to
the outer eyelid
The Eye Cup:
Comprised of an
inflatable bladder &
rigid eye cup
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LipiFlow® Thermal
Pulsation System
Mean Meibomian Gland Score
Total Meibomian Gland Score
(0 to 45)
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Statistically Significant Increase
in Mean Meibomian Gland Score
from Baseline after Crossing
Over to LipiFlow®
LipiFlow®
iHeat™
iHeat™ crossover to LipiFlow®
14.3±8.7
15
P<0.0001*
16.7±8.7 11.7±7.3
P<0.0001*
10
ow
Fl
pi
Li
0
27
Baseline Baseline
Week 4
Week 4
N=136
N=128
N=132
5
14.3±4.8
14.8±4.8
14
P<0.0001*
P<0.0001*
11.2±5.4
8.1±5.5
0
Baseline Baseline
N=130
N=136
Week 2 Week 2
N=130
N=136
P<0.0001*
P<0.0001*
Crossover
7.6±5.8
7
7.9±5.6
pi
pi
Fl
ow
®
Crossover
21
®
P=0.0027*
Statistically Significant Reduction
in Mean SPEED Score from
Baseline After Crossing Over to
LipiFlow®
ow
6.3±4.7
5.3±3.5
LipiFlow®
iHeat™
iHeat™ crossover to LipiFlow®
Fl
7.4±5.5
P<0.0001*
28
SPEED Score (0 to 28)
5.4±3.5
Week 2
N=130
Li
Li
Seconds
5.5±2.9
P=0.0003*
Week 2
Mean SPEED Questionnaire Score
Statistically Significant Increase
in Mean Tear Film Break Up
Time from Baseline After
Crossing Over to LipiFlow®
6.9±5.0
N=136
*2-tailed paired sample t-test for mean change over time for28each group
Caution: Investigational device. Limited by United States law to investigational use. The LipiFlow
System is not approved for use in the U.S.
Mean Tear Film Break up Time
LipiFlow®
iHeat™
iHeat™ crossover to LipiFlow®
P<0.0001*
Crossover
5
N=130
10
6.1±5.6
5.6±3.9
®
6.3±3.5
Week 4
Week 4
N=128
N=132
0
Baseline Baseline
N=130
N=136
Week 2
N=130
Week 2
N=134
Week 4
N=128
Week 4
N=132
*2-tailed paired sample t-test for mean change over time for each group29
*2-tailed paired sample t-test for mean change over time for each group30
Caution: Investigational device. Limited by United States law to investigational use. The LipiFlow
System is not approved for use in the U.S.
Caution: Investigational device. Limited by United States law to investigational use. The LipiFlow
System is not approved for use in the U.S.
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9/2/14
SUMMARY
Thank you for your attention!
!  Ocular Surface Disease is more
prevalent than we previously believed
!  It is a major factor in visual outcomes
after cataract surgery
!  Greater awareness by patients and
physicians will enable more prompt
treatment and greater patient
satisfaction
Parag A. Majmudar, MD
e-mail: [email protected]
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