Anne_Sulley_-_Latest_learnings_Astigmatism

10/11/2012

Astigmatism and its prevalence

Astigmatism ‐ prevalence, insights & opportunities

Spherical or </=0.50DC

November 2012 24% 53% 23%

Anna Sulley BSc (Hons) MCOptom FBCLA FAAO Medical Affairs Associate Director EMA

>/=0.75DC in one eye only >/= 0.75DC in both eyes (N=11,624)

Young G, Sulley A and Hunt C. Prevalence of Astigmatism in Relation to Soft Contact Lens Fitting.

Eye & Contact Lens 2011; 37 (1): 20‐25

Prevalence eyes with various levels astigmatism 30%

Prevalence astigmatism increases with age 30%

Hyperopes Myopes

25%

0.50DC or less >/= 0.75DC at least one eye

25%

All 31.7% myopes >0.75DC

15% 15.7% hyperopes >0.75DC

10% 5%

15%

10%

5%

0% 0.00 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 >2.50 Cylinder (D)

Young G, Sulley A and Hunt C. Prevalence of Astigmatism in Relation to Soft Contact Lens Fitting.

Eye & Contact Lens 2011; 37 (1): 20‐25

50 45 40 35 30 25 20 15 10 5 0

0% 8‐19

20‐29

30‐39

40‐49

50‐59

60‐70

Age range (Years) Young G, Sulley A and Hunt C. Prevalence of Astigmatism in Relation to Soft Contact Lens Fitting.

Eye & Contact Lens 2011; 37 (1): 20‐25

Prevalence Astigmatism vs. Fits Data

Percentage (%)

20%

Prevalence

Prevalence

20%

Although toric soft CL prescribing increasing ‐ not to levels expected if all astigmats fully corrected

Astigmatic Drop Outs A high percentage of CL drop‐ outs are astigmats 65% of drop‐outs: ≥ 0.75DC in one eye

47 20

Prevalence Toric fits UK ‐ Industry astigmatism (≥0.75D data 2 at least 1 eye) 1

19

Norway 3

Young, Veys, Pritchard & Coleman Ophthal Phsiol Opt 2002; 22: 516‐52

• Astigmats over represented among CL drop‐outs • Poor vision due to uncorrected cylinder contributing factor in CL discontinuation

1. Young G, Sulley A & Hunt C. Prevalence of Astigmatism in Relation to Soft Contact Lens Fitting; Eye & CL, 2011: 37: 20‐25 2. GfK Fit Audit FY 2011 3. 19.4% CL wearers use torics – Internal data, 2012

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Studies to gain key insights into astigmatic patient behaviour, awareness and needs

1. Non‐toric Use Clinical Study No. of subjects Spherical wearers: 67 CL Drop‐outs: 72 Neophytes: 61

Spherical Wearers

1 – Non‐toric User Clinical Study

2 – Qualitative Interviews

3 ‐ Astigmatism Awareness Survey

4 – Usage & Attitude Survey

Background questionnaire to evaluate ease of fitting non‐toric CL users & clinical performance 2 ASD torics

Interviews and focus groups

1‐month, open label, randomised, DW study

Practitioners and astigmats (lapsed, current spherical, neophytes)

Consumers aged 18 to 54 (n=819)

200 astigmats

60 each group

Spectacles/CL wearers (n=538)

n=3525 (n = 1018 astigmats)

UK, 16 sites

UK & Italy

UK

9 countries in Europe

On‐line survey ‐ Independent MR agency

On‐line survey – Independent MR agency

Drop-outs Neophytes

CL wearers Aged 16‐54 years Representative CL population by age, gender, modality

Neophytes – key reasons for not wearing CLs (n=61)

Male

Female

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Drop‐outs – key reasons for discontinuation (n=72)

Spectacles more convenient

39%

Concerned about comfort

33%

Haven't got round to it

33%

Cost

30%

Never thought about it

39% 35%

Poor vision

31%

Don't like thought of putting CLs in eye

Discomfort Spectacles more convenient 31%

Dryness

24%

23% Cost

Get lost in eye

21%

18%

Irritation/infections

15%

CLs too much trouble to care for

15%

Handling

15%

Reasons wider beliefs of non‐ lens wearers

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Ran out of CLs and didn't get round to getting more

15%

CLs too much trouble to care for

15%

Key factor was CLs did not meet specific vision needs

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Background questionnaire ‐ Spherical wearers – key reasons for not wearing toric CLs (n=67)

2. Qualitative interviews Lapsed Wearers

Unaware there were lenses for astigmatism

Current Lens Wearers

28%

Unaware I had astigmatism

22%

Cost

18%

Practitioner never offered me toric CLs

12%

Astigmatism didn't warrant toric CL

12%

Main reason for not wearing ‐ ‘lack of awareness’

Non wearers

1 in 10 said TSCLs not offered Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Astigmatism qualitative interview s, UK & Italy, 60 practitioners, 60 patients, 2011

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Do we always communicate about astigmatism, the implications and the options?

Torics are hard to fit, with limited Rx & take up too much chair‐time

3 ‐ Astigmatism Awareness Survey

What is astigmatism?

Are CLs are Ok with astigmatism?

I am not sure I have the skills needed to fit them

Low awareness

•

•

If there is an alternative, my practitioner will tell me

My patients just want low cost – if not, they’d ask for something else Practitioner

If I know a little more about the options, I might try toric CLs

Astigmat

Can astigmatism can be corrected with CLs?

Nearly 4 out of 10 (38%) don’t know what astigmatism is

Net don’t know / no = 57%

15%

Happy to switch if vision with toric CLs as good as spex

‘What’s in it for me’ – and CLs are less profitable

Yes

‐ recommended as most suitable lens 50

77%

30 %

7%

42

20 N=161

1%

10

N=538

0 Astigmats

Non‐astigmats

On‐line survey in 9 countries across Europe (n=3525), 2011, Independent MR agency UK, France, Germany, Italy, Spain, Sweden, Russia, Poland & Saudi Arabia

4. European Usage & Attitudes Survey

Do patients know about astigmatism and toric lenses?

Low toric CL penetration vs astigmatism prevalence

Satisfaction levels with vision correction P<0.05

Benefits & opportunities

Spherical wearers – key reasons for not wearing toric CLs

Successfully completed 1‐month

Unaware there were lenses for astigmatism

P<0.05

60

Lack of awareness and other barriers

28%

Unaware I had astigmatism

22%

Cost

50 68

58 50

20

Percentage (%)

50 40 30 20 10

47 20

18%

Practitioner never offered me toric CLs

12%

Astigmatism didn't warrant toric CL

12%

Can astigmatism can be corrected with CLs?

Toric soft CL Astigmats wearing wearers (n=1018) spectacles (n=205)

Lapsed wearers (n=242)

On‐line survey in 9 countries across Europe (n=3525), 2011, Independent MR agency UK, France, Germany, Italy, Spain, Sweden, Russia, Poland & Saudi Arabia

92

94

94

Overall (183/200)

Spherical CL wearers

Lapsed wearers

86

80 60 40 20 0 Neophtyes

9 / 10 want practitioners to discuss CLs as an option for astigmatism 33%

57% Prevalence Toric fits UK ‐ astigmatism Industry data (≥0.75D at 2 least 1 eye) 1

0

100

Net don’t know / no = 57%

0

10

Proportion subjects (%)

Data on file, JJVC, 2012, UK adults aged 18‐54, Independent MR agency

Satisfaction with VC (%)

32

1%

No

Very important Somewhat important Neither important nor unimportant Not very important Not at all important

30

Practitioner recommendation – critical factor in choice of vision correction

P<0.05 40 33%

23%

40

N=538

Reason why people wear current lens

9 / 10 important that practitioners discuss CLs as an option to correct astigmatism

57%

70

Don't know

4. European Usage & Attitudes Survey

3 ‐ Astigmatism Awareness Survey Only 1 in 4 non CL wearing astigmats have discussed CLs as an option with their practitioner

No

Data on file, JJVC, 2012, UK adults aged 18‐54, Independent MR agency

Astigmatism qualitative interview s, UK & Italy, 60 practitioners, 60 patients, 2011

Yes

42%

43%

15%

42%

7%

43%

1. Zikos GA, Kang SS Ciuffreda KJ et al. Optom Vis Sci 2007;84:11 1039‐45 Yes No Don't know

1% Very important Somewhat important Neither important nor unimportant Not very important Not at all important

1%

3. Young G, Mcllraith R. Optom Vis Sci 2008; E-abstract 85051

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Low Astigmats

Range of options for astigmats • Toric soft lenses

• Astigmatism, not fully corrected, leads to:

– Wide range materials, modalities and replacement frequencies

– Loss visual performance at low‐contrast – Ocular discomfort with accommodative problems with NV or PC work (asthenopia)

• Manufacturing advances • Wide range parameters and powers

• RGPs

• Do thicker or higher modulus spherical CLs mask astigmatism?

– Corneal astigmatism‐ spherical – High corneal toricity – BS toric – Large diameter RGPs

– No significant masking effect with either 1‐4

• Do aspheric soft CLs improve visual performance in low cylinders vs spherical CLs?

• Hybrid lenses • Scleral lenses • Multifocal RGPs

– Scant evidence ‐ for typical pupils (4mm & 6mm), vision superior with toric soft CLs and spectacles5

– Translating or aspheric

1.

2.

3.

4.

5.

• Toric soft multifocal lenses

Cho PC and Woo GC. Vision of low astigmats through thick and thin lathecut soft contact lenses. Cont Lens Anterior Eye 2001;24:153‐160.

Bernstein PR, Gundel RE and Rosen JS. Masking corneal toricity with hydrogels: does it work? Int Contact Lens Clinic 1991;18: 67‐70.

Edmondson LL, Edmondson W and Price R. Masking astigmatism Ciba Focus Night & Day vs Focus Monthly. Optom Vis Sci, 2003;80 (supp) 184.

Snyder C. Masking of astigmatism with selected spherical soft contact lenses. J Am Optom Assoc 1989 Oct;60(10):728‐31.

Morgan PB, Efron SE, Efron N et al. Inefficacy aspheric soft CLs for correction of low levels of astigmatism. Optom Vis Sci 2005;82:9 823‐828.

Lid Movements

Toric Soft Behaviour Anatomical Variations

• Patient variables – Inter‐canthal Angle – affects rotation – Palpebral Aperture Size – affects orientation – Degree Myopia – affect orientation

• Effect lids – – – –

θ2

θ3

Position and lid angles Angle lids – affects orientation Lid tension – affects instability Force and direction blink

Young G et al. Clinical Evaluation of Factors Influencing Toric Soft Contact Lens Fit. Optom Vis Sci 2002; 79 ; 1, 11‐19.

θ1

θ6

θ4 θ7

θ5

Lid position / Angles & Apertures

Dynamic forces acting on a toric soft lens ‐ High‐speed video recording pre & post blink Palpebral aperture & Lid tension

Challenges to toric lens stability

Soft Toric Lens Behaviour • Lens effects

Blink

Blinking

Versional tasks

8 Cardinal Directions

Eye movements

Saccadic Diagonal Gaze

Gravity

Head movements

– Interaction between CL & lids controlled by lens mass profile • thickness, material, elasticity, power

– BVP effects depend on lens design and influence fit – Different orientation position and rotational stability on same eyes with different designs * Young G et al. Clinical Evaluation of Factors Influencing Toric Soft Contact Lens Fit. Optom Vis Sci 2002; 79 ; 1, 11‐19.

Hanks et al. Contact lens forum. 1983 819: 31-35

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How do the latest soft toric designs perform?

Accelerated Stabilisation Design (ASD)

• Recent literature review toric soft developments and performance – Prism‐ballast, periballast, thin zone (double slab‐off / dynamic stabilisation), truncation, back surface and front surface torics – Newer lens designs reduce lens rotation & improve rotational stability – Better reproducibility, more frequent replacement schedules, expanded parameters, high permeability and better wetting characteristics contributed to increased success

Edrington TB. A literature review: The impact of rotational stabilization methods on toric soft contact lens performance. CLAE 2011;34:3 104‐110.

Rotational stability toric soft CLs during natural viewing conditions

Eye tracker tasks • 15 minutes settling

Settling Newspaper Reading Visual search task Extreme version

Zikos GA, Kang SS Ciuffreda KJ et al. Optom Vis Sci 2007;84:11 1039‐45

• Paper reading 12 ‐ 30o & return to primary gaze • Blink with metronome every 1.5 seconds • Gaze change every 20 seconds • Up, down, left & right over 40o horizontal & 32o vertical range

Zikos GA, Kang SS Ciuffreda KJ et al. Optom Vis Sci 2007;84:11 1039‐45

Standard deviation lens rotation for 4 visual tasks with 2 toric soft designs

Eye movements ‐ Settling Average rotation during 15 mins post insertion

P<0.01

10

ASD lens Prism‐ballast lens

5

Rotation

10 9 8 Standard 7 Deviation 6 (degrees) ‐ lower 5 numbers mean 4 less variability in 3 2 rotational 1 position 0

• 40cm, 40o horiz & 15o vertical

0 0.5 ‐5

1

3

5

10

15

ASD Prism Ballast

‐10

Zikos GA, Kang SS Ciuffreda KJ et al. Optom Vis Sci 2007;84:11 1039‐45

Zikos GA, Kang SS Ciuffreda KJ et al. Optom Vis Sci 2007;84:11 1039‐45

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Effect of gravity and gaze direction on toric lens orientation and VA

Results

ACUVUE® OASYS® for ASTIGMATISM Proclear® Toric

Accelerated Stabilisation Design

AIR OPTIX® for Astigmatism PureVision® Toric

Prism Ballasted Design

McIlraith R et al, Toric lens orientation and visual acuity in non‐ standard conditions. CLAE 2010 Feb;33(1):23‐6;

McIlraith R et al, Toric lens orientation and visual acuity in non‐ standard conditions. CLAE 2010 Feb;33(1):23‐6;

VA Fluctuations During Wear

Chamberlain P et al. Fluctuation in visual acuity during soft toric contact lens wear. Optom Vis Sci 2011 Apr;88(4):E534‐8.

Chamberlain P et al. Fluctuation in visual acuity during soft toric contact lens wear. Optom Vis Sci 2011 Apr;88(4):E534‐8.

Simulating the “Real World” in a laboratory setting….

Fitting Torics – Never Easier!

Enhanced designs

Improved manufacture Better materials Convenience Zikos GA, Kang SS Ciuffreda KJ et al. Optom Vis Sci 2007;84:11 1039‐45

Young G, Mcllraith R. Optom Vis Sci 2008; E‐ abstract 85051

Chamberlain P, Morgan P, Moody K Maldonado‐ Codina C,. Optom Vis Sci 2011;88(4):1

Rx

– – – –

Thin, comfortable Fast, consistent stabilisation Predictable orientation Stable, clear vision

– Reproducible – Wetting agents, SiHs – Reusable or daily disposable – Wide parameter range

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Number of trial fit attempts

Lens orientation at 1‐week 85% 1DAMfA within 5° of zero 82% AOfA within 5° of zero

Most lenses minimal rotation (55% 1‐wk)

100

No sig differences in orientation between dispensing & follow‐ ups

80

% Eyes

SW

DO

Neo

94

60

86

84

40 16

20

14

5

0.7

0

0

0 1

2

3

No. of Trial Fits

• 88% eyes successfully fitted on 1st attempt Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Key Features of a Successful Fit

What is the process?

Convert spec Rx to ocular Rx (BVD)

Accurate, up to date refraction

Successful fit

Loose vs tight fit *

• Good physical fit

• Tighter

– Same as spherical lens

• Stabilisation

ֳcyl if there is choice; leave axis unchanged

Trial lens cylinder & axis close to Rx

– Speed to stabilise – Consistency of orientation

• Orientation – Quantity & Rotational Stability – Orthogonal eye movements

Allow settling – assess fit & orientation

If necessary, change lens to allow for rotation

Poor Vision Problem Solving

⇒ more stable orientation position

• Looser ⇒ faster reorientation

• Need balance fitting characteristics – Reasonable stability with enough rotational movement for correct orientation * Young G et al. Clinical Evaluation of Factors Influencing Toric Soft Contact Lens Fit. OVS2002; 79 ; 1, 11‐19.

Explaining Poor Vision

Poor VA

• Rotate lens to correct position and recheck vision

Is lens rotationally stable?

– Confirms whether mislocation is sole cause

• Toric soft mislocation ‐ rules of thumb

Yes

No

Is lens orientating as expected?

Is fitting otherwise correct?

Yes

No

Yes

No

Return Lens

Rotational direction?

Use different lens design

Alter fit

Clockwise add

Anti-clockwise subtract

Re-order

Re-order

– Induced cyl = 2x induced sphere – Axis induced cyl = opposite direction to mislocation – Induced cyl = 1/3 correcting cyl for every 10° rotation (up to 30°)

• Computer programmes

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Binocular VA at 1‐week vs. baseline Poorer VA

Remember Comfort and Physiology • Astigmats deserve same benefits as others

P<0.0001

Vision

Comfort

Health

• Consider lens material characteristics

(6/6)

– Wettability, oxygen delivery, lubricity and modulus – SiH 1st choice reusable?

– Convenience benefits DDs

Better VA

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

92

94

94 86

100% 90%

Typical Confidence interval

80% 70%

*

60% 50% 40% 30% 20% 10%

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

N

o

M ed

s M ed s

H i As Ast g. tig .< 1.

50

M yo p y p es er op es

<4 5 >= 45

e

Lo

Spherical Lapsed Neophtyes CL wearers wearers

H

Overall (183/200)

Ag

M al e m ale

0% Fe

100 90 80 70 60 50 40 30 20 10 0

Success rates by pre‐determined criteria

Success rate (%)

Proportion subjects (%)

Successfully completed 1‐month

* Significant for AOfA, P=0.03

Sulley A, Young G, Osborn K, et al. A multi‐centre study of astigmatic nonusers of soft toric contact lenses. BCLA Conference 2011, Poster Presentation.

Wide range of successful options ….

Enhance communication with astigmats and adopt proactive approach to discussing toric soft lenses and their benefits

• Wide range options •Stable, predictable designs •Range materials, Rx, replacement • Ease & speed of fitting • High success rates • Excellent vision & comfort performance

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