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Less Than Perfect Outcomes After

Uneventful Cataract Surgery:

What Are We Missing?

Parag A. Majmudar, MD Associate Professor of Ophthalmology Rush University Medical Center Chicago Cornea Consultants, Ltd. Chicago, IL USA

!  I am a consultant for Allergan, Alcon, B&L, and Tear Science

!  I have no financial interest in any product discussed herein

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 pre-operatively

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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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)

–  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

!  What time is considered abnormal? – 5 seconds? – 7 seconds? – 9 seconds?

Tear Break up Time

Tear Break up

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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Topography: Excellent Tool for Diagnosing a Poor Tear Film

Dry Spots

William Trattler, MD

Recommenda;ons  for  all  cataract  surgery  pa;ents:    Preop  Topography

58  year  old  male  with  visually  significant  cataract  OS,  interested  in  a  premium  IOL.    

William Trattler, MD

Preop Topo after 1 day of Treatment

Same  paFent  :    1  day  aZer  starFng  lubricaFng  drops.      William Trattler, MD

.

Preop Topo after one week of Treatment

Same  paFent:    one  week  aZer  iniFaFng  topical  steroids  along  with  lubricaFng  drops  

William Trattler, MD

Preop Evaluation

60 year old male: Initial Consultation for Presbyopic IOL

William Trattler, MD

Dry Eye Identified: One week after cyclosporine BID

William Trattler, MD

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!  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:

•  Dry Eye •  EBMD

Summary

William Trattler, MD

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

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 –  Secreted by lacrimal glands

!   Mucins provide viscosity and stability during blink cycle

Image from Dry Eye and Ocular Surface Disorders, 2004

“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

Meibomian Gland Dysfunction: A Prevalent Condition with

Consequences

1.  Nichols KK, et al. The international workshop on meibomian gland dysfunction: executive summary. 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. 22

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MGD: Toothpaste

Image Courtesy of Gary N. Foulks, MD

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

!  Corticosteroids !  Antibiotics: azalides (Azasite) !  Cyclosporine A (topical, Restasis)

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LipiFlow® Thermal Pulsation System

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The Lid Warmer: Comprised of a precision heater, eye insulation & vaulted shape

The Eye Cup: Comprised of an inflatable bladder & rigid eye cup

LipiFlow® Thermal Pulsation System

!   Heat applied to the palpebral surfaces of the upper and lower eyelids directly over the meibomian glands

!   Graded pulsatile pressure delivered to the outer eyelid

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LipiFlow® Thermal Pulsation System

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N=130

6.3±3.5

N=136

5.6±3.9

N=136

6.1±5.6

N=130

14.3±8.7 P<0.0001*

N=128

16.7±8.7

P<0.0001*

Mean Meibomian Gland Score

28

20

10

0

15

5

Baseline

Tota

l M

eibom

ian G

land S

core

(0

to 4

5)

Baseline Week 2 Week 2 Week 4 N=132

11.7±7.3

Week 4

P<0.0001*

LipiFlow® iHeat™ iHeat™ crossover to LipiFlow®

Crossover

LipiFl

ow®

Statistically Significant Increase in Mean Meibomian Gland Score

from Baseline after Crossing Over to LipiFlow®

*2-tailed paired sample t-test for mean change over time for each group Caution: Investigational device. Limited by United States law to investigational use. The LipiFlow System is not approved for use in the U.S.

N=136

5.4±3.5

N=136

5.3±3.5

Mean Tear Film Break up Time

29

10

5

0 N=130

5.5±2.9

Baseline

Seco

nds

Baseline Week 2 N=130

6.9±5.0 P=0.0003*

Week 2 Week 4 N=128

7.4±5.5

P=0.0027*

N=132

6.3±4.7

Week 4

LipiFlow® iHeat™ iHeat™ crossover to LipiFlow®

Crossover

LipiFl

ow®

Statistically Significant Increase

in Mean Tear Film Break Up Time from Baseline After

Crossing Over to LipiFlow®

Caution: Investigational device. Limited by United States law to investigational use. The LipiFlow System is not approved for use in the U.S. *2-tailed paired sample t-test for mean change over time for each group

P<0.0001*

N=134

11.2±5.4

N=136

14.8±4.8

Mean SPEED Questionnaire Score

30

28

14

0

21

7

N=130

14.3±4.8

Baseline

SPEE

D S

core

(0

to 2

8)

Baseline Week 2 N=130

8.1±5.5

P<0.0001*

Week 2 N=128

7.6±5.8

P<0.0001*

Week 4

LipiFlow® iHeat™ iHeat™ crossover to LipiFlow®

Crossover

LipiFl

ow®

Statistically Significant Reduction

in Mean SPEED Score from Baseline After Crossing Over to

LipiFlow®

Caution: Investigational device. Limited by United States law to investigational use. The LipiFlow System is not approved for use in the U.S. *2-tailed paired sample t-test for mean change over time for each group

N=132

7.9±5.6

Week 4

P<0.0001*

P<0.0001*

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SUMMARY

!  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, MDe-mail: pamajmudar@chicagocornea.com

Thank you for your attention!