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10/27/2017
1
Evidence for Technology
in the Treatment of Dry EyeCOPE: 44090-AS
Chris Lievens, OD MS FAAO
Professor
Chief of staff
Southern college of optometry
Dry eye
Chronic
Multifactorial
Characterized by disturbances in tear film &ocular surface
Females > male
Dry eye
Environmental conditions
Arid
Computer-use
Contact lens wear
Systemic disease
Sjogren’s syndrome
Lupus
Stevens-Johnson syndrome
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Doctors and Patients See Dry Eye Differently
Patients often perceive their dry eye symptoms to be more severe than their ECP suspects based on clinical signs
ECPs lack a gold standard clinical test for dry eye, limiting their ability to objectively assess symptoms in many patients
1. Eisenberg JS. Rev Optom. 2003;140(01). Issue: 1/15/03.
Severity of Dry Eye
Symptoms
Doctor
Assessment
Patient
Assessment
Severe 9% 19%
Moderate 20% 36%
Mild 47% 23%
Dry Eye Demographics
Estimate of dry eye disease in Americans over 50
3.23 million women
1.68 million men
Tens of millions more have less severe dry eye
The prevalence of severe symptoms and/or clinical diagnosis may be greater in Asian and Hispanic women
Public health significance of dry eye is likely to increase: US population aged 65-84 years will grow by 100% between 2000 and 2050
1. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye
WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107.
Dry Eye Can Have a Marked Impact on Quality of Life
Dry eye can have a marked impact on patients’ quality of life (QoL), particularly affecting their daily roles and vitality1
QoL in patients with severe dry eye is comparable to that in patients with severe angina or disabling hip fracture2
Respondents in this study stated that they would be willing to give up 1.6 years of their lives to be free of severe dry eye
In patient with mild dry eye, the QoL value is roughly equivalent to that of psoriasis2
1. Mertzanis P, et al. Invest Ophthalmol Vis Sci. 2005;46:46-50. 2. Schiffman RM, et al. Ophthalmology.
2003;110:1412-19.
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Dry Eye Disease
inflammation of the ocular surface and increased osmolarity of the tear film
common and is often under diagnosed
Signs don’t always correlate with symptoms
negatively impact vision quality, fluctuating vision, reduced contrast sensitivity, and increased glare
Significant psychological impact
Patients have reported a willingness to trade years at the end
of life to be free of dry eye disease
Crucial Factors in Dry Eye Disease
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptomsof discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.
1. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye
WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107.
Why Is the Eye Dry?DRY EYE
Aqueous-deficient
Sjogren
Syndrome
Dry Eye
Non-Sjogren Dry Eye
Meibomian OilDeficiency
Vitamin A-Deficiency
Disordersof Lid
Aperture
Topical DrugsPreservatives
Low BlinkRate
Contact LensWear
Drug ActionAccutane
Ocular SurfaceDisease
eg, Allergy
Lacrimal Deficiency
LacrimalGland Duct
Obstruction
Reflex Block
Systemic Drugs
Intrinsic Extrinsic
Primary
Secondary
1. Figure adapted from: The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry
Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107.
Evaporative (~80%)
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Lid aperture issues
Lid laxity
Lagophthalmous
Floppy eye lid syndrome
Other CAUSES OF DRY EYE symptoms
Medications (BAK)
Ophthalmic
Glaucoma medications
Allergy medications
Other Causes of dry eye symptoms
Demodex
Demodex folliculorum
Demodex brevis
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Causes of dry eye symptoms
blepharitis affects
millions
upwards of 80% of
those patients could have Demodex mites
Causes of dry eye symptoms
Demodex
Men > Women
The incidence of Demodex infestation increases age
84% of the population at age 60
~100% of the population older than 70 years of age
Other Causes of dry eye symptoms
Diabetes
Thyroid disease
Autoimmune disease
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Psychology of dry eye
89 dry eye subjects (13 sjogren’s patients & 73
control subjects
Zung self rating anxiety scales (SAS)
zung self rating depression scales (SDS)
ocular surface disease index (OSDI)
Psychology of dry eye
Anxiety and depression scores of the DES group were significantly higher than the control group
SAS and SDS scores were found to be correlated with OSDI
What are the dry eye
‘personalities’ that we are dealing with?
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Psychology of the examination
Change the single visit mentality
Treatment is a process
Individualized care
Patient’s thoughts?
72% of patients Artificial tears only
82% of patients Demand “something
better”
97% of patients Report condition as
“frustrating”
The Gallup Organization Inc. The 2008 Gallup Study of Dry Eye Sufferers. Princeton, NJ: Multi-
Sponsor Surveys Inc; 2008.
Lid Wiper Epitheliopathy (LWE)
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LWE
New diagnosis?
2002 coined by Korb et al.
lid wiper is the portion of the eye lids that is in apposition to the ocular
surface during a blink
LWE has been reported to occur both with and without contact lens wear
Correlates with symptoms for both dry eye and contact lens discomfort
LWE
LWE is increased friction between the lid wiper and the ocular surface due to inadequate lubrication
The lid wiper comes into contact with the anterior ocular surface over 3,000 to 15,000 times a day
The lid wiper is in apposition to the globe at all times and would be constantly susceptible to mechanical trauma with poor lubrication.
The ocular surface, in contrast, comes in contact with the lid wiper for only a fraction of second (albeit, frequently). \
It would be expected that in any state of dry eye disease, the lid wiper would suffer greater trauma and epithelial compromise than would be ocular surface
LWE
Have we been looking?
Is this diagnosis the ‘missing link’?
How should it be detected?
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Method
Lissamine Green (or NaFl)
Though the lid wiper can be viewed in bright white light, disturbances in the
tissue and LWE can only be observed with the aid of vital dyes
Upper conjunctiva
Wait ~1 minute
Evaluate conjunctiva and lid margin (gently)
The term epitheliopathy is used in LWE to note the uptake of vital dye(s)
thereby implying that the tissue is found to have devitalized cells and/or is in the presence of neighboring cellular apoptosis
1) Grading of Horizontal Length of Fluorescein and/or Lissamine Green Staining of the Epithelium
of the Lid Wiper(Korb et al., 2010)
Horizontal Length of Staining Grade
<2 mm 0
2-4 mm 1
5-9 mm 2
>10 mm 3
2) Grading of Sagittal Height (Width) of Fluorescein and/or Lissamine Green Staining of the
Epithelium of the Lid Wiper(Korb et al., 2010)
Sagittal Height (Width) of Staining Grade
<25% 0
25% - 50% 1
50% - 75% 2
>75% 3
Tear osmolarity
Tear lab osmolarity system (tear lab)
single-use microchip embedded with gold electrodes
50 nl collected
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Tear osmolarity
Osmolarity increases with advancing dry eye disease
Asymmetry of findings also indicative of problems
Inflammadry
Rapid pathogen screening
Detects elevated MMP-9 in tears
Studies indicate MMP-9 as a useful biomarker for diagnosing, classifying and monitoring DED
InflammaDry
Identifies elevated levels of MMP-9 in tear fluid
Rapid: 10 minute results
In-office: point-of-care immunoassay test aids in diagnosis at the time of office visit
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Dry Eye Disease and MMP-9
Matrix metalloproteinases (MMP) are proteolyticenzymes that are produced by stressed epithelial cells on the ocular surface1
MMP-9 in Tears
Normal range between 3-41 ng/ml
Correlates with clinical exam findings1
[1] Chotiakavanich S, de Paiva CS, Li de Quan, et al. Invest Ophthalmol Vis Sci 2009; 50(7): 3203-
3209.
MMP-9
Group MMP-9 Activity (ng/mL)
Normal (n = 18) 8.39 ± 4.70
DTS1 (n = 15) 35.57 ± 17.04*
DTS2 (n = 11) 66.17 ± 57.02*
DTS3 (n = 9) 101.42 ± 70.58*†
DTS4 (n = 11) 381.24 ± 42.83*‡
Tear MMP-9 Activity in Normal Control and DTS Groups.
Data shown are the mean ± SD.*P < 0.008 Compared with normal.†P < 0.003 Compared with normal and DTS1.‡P < 0.001 Compared with normal and the other DTS severity groups
Invest Ophthalmol Vis Sci. Jul 2009; 50(7): 3203–3209.
inflammadry
a small applicator touched to the conjunctiva
snaps into a test cassette
Cassette tip is submerged In solution
results are obtained in 10 minutes
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Inflammadry
Pro’s
Inexpensive
Fast
Identifies presence of inflammation
Con’s
Does not quantify inflammation (per se)
Does not identify cause
Oculus Keratograph 5M
Tear film analysis by non-invasive (non-contact) scanning
NIKBUT
Tear meniscus height
Non-contact meibography (meiboscan)
Tear dynamics
Bulbar redness
topography
Meibomian Gland Dysfunction (MGD) Is the Most Common Cause of Evaporative Dry Eye Disease1-3
“Meibomian gland dysfunction (MGD) may well be the
leading cause of dry eye disease throughout the world.”4
—The International Workshop on Meibomian Gland Dysfunction:
Executive Summary
1. 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.
2. Lemp MA, Crews LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-8.
3. Shimazaki J, Sakata M, Tsubota K. Ocular surface changes and discomfort in patients with meibomian gland dysfunction. Arch Ophthalmol. 1995;113(10):1266-1270.
4. Nichols KK, et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011;52(4):1922-1929.
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Classification of Meibomian Gland Dysfunction
Meibomian Gland Disease
Congenital Neoplastic Acute Other
Meibomian Gland Dysfunction (MGD)
Low Delivery High Delivery
Primary Secondary(e.g., medications)
Primary Secondary• Trachoma
• Ocular Pemphigoid
• Erythema
Multiforme
• Atopy
Primary Secondary• Seborrheic
Dermatitis
• Acne Rosacea
• Atopy
• Psoriasis
Primary Secondary• Seborrheic
Dermatitis
• Acne Rosacea
Alteration of Tear Film Eye IrritationClinically Apparent
Inflammation
Ocular Surface Disease
Including Dry Eye
Hyposecretory (Meibomian Sicca)
Hypersecretory (Meibomian Seborrhea)
Obstructive
Cicatricial Non-Cicatricial
1. Nichols KK. Invest Ophthalmol Vis Sci. 2011;52:1922-29.
Challenges of Current MGD Therapies38
38
Therapy
• Warm compresses
• Eyelid scrubs
• Manual gland expression
Challenges
• External heat application is
inadequate
• Significant discomfort
• Limited compliance
• Only the upper portion of the
glands are treated or expressed
LipiView
Uses interferometry to measure lipid layer thickness between blinks
Quantitative assessment in interferometric color units (ICU)
Pilot study: 137 consecutive patients completed SPEED test, then measured LLT by Lipiview
SPEED >10, 74% had LLT of 60nm or less
SPEED = 0, had LLT 75nm or greater
As LLT increases, symptom score decreases
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microscopy
Demodex visible at slit lamp
Cylindrical dandruff @ Base of lashes
Most common ecoparasite
Microscopy for patient education
Upper 1/3 has four pairs of legs that
allows it to move from one follicle to
the next
Remaining body is an abdomen-tail
Demodicosis
Demodex folliculorum
Buries within hair follicle (tail protrudes)
Demodex brevis
Favor sebum-rich environments like Meibomian glands
Organisms inhabit hair follicles & glands Feed on sebaceous oils & dead skin cells; carry
pathogenic bacteria
Avoid light: most active at night
Overpopulation causes localized inflammation
Demodicosis
Demographics:
More prevalent in elderly
Male > female
More common in rosacea patients
Symptoms:
Grittiness and/or burning
Itching of eyelids
Crusting of eyelashes
Poor cosmesis (i.e. eye & eyelid redness)
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Demodicosis
Key objective findings:
Cylindrical dandruff (“sleeves”) at lash base (especially lash
line most inward)
Possible to see mite tails with lash manipulation
Demodicosis - Management Options
1. In-office: microblepharoexfoliation
(BlephEx™)
2. In-office: Cliradex Complete
3. Home therapy:
Tea-Tree oil tx
Key Reasons to Control Lid Flora and
Associated Inflammation
Blepharitis
Rosacea / Ocular Rosacea
MGD & secondary staph overpopulation
Pre-op surgical prophylaxis
Refractive
Cataract
Retinal
Contact lens wear
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Dr. O’Brien Recommended Pre-Op Lid
Hygiene Regimen with Avenova
No lid disease
1 week prior to surgery*
Some Blepharitis or MGD Dry Eye
2 weeks prior to surgery*
Moderate Blepharitis or MGD Dry
Eye
3 weeks prior to surgery*
Severe Blepharitis or MGD Dry Eye
4 weeks prior to Surgery*
* Apply to both eyelids and lid margins twice a day
Terrance P. O’Brien, MDBascom Palmer Eye Institute
Contact Lens Infiltrative Events
“The presence of substantial (>100 colony-forming units)
coagulase-negative staphylococci bioburden on lid margins was associated with about a five-fold increased risk for the development of a CIE (p
= 0.04).”Szczotka-Flynn L, Jiang Y, Raghupathy S, Bielefeld RA, et. al. Corneal inflammatory events with daily
silicone hydrogel lens wear. Optom Vis Sci. 2014;91(1):3-12.
“Lid hygiene should be as common
place and accepted as regularly brushing your teeth”
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Future Work:Surface Health and Visual Acuity
Disruptions in tear film can lead to wavefront aberrations and reduction in visual performance1-3
Contact lenses divide the tear film into two layers, increasing tear film breakup and potentially degrading
visual acuity4
Tear film disruption appears to be a common factor in reducing visual acuity in contact lens patients and those with dry eye3
TBU, tear breakup.
1. Koh S, et al. Am J Ophthalmol. 2002;134:115-7. 2. Tutt R, et al. Invest Ophthalmol Vis Sci. 2000;41:4117-23. 3.
Himebaugh NL, et al. Optom Vis Sci. 2012;89:1590-1600. 4. Craig J, et al. Invest Ophthalmol Vis Sci.
2013;54:TFOS123-TFOS156.
Prevent papillae in CL wearers