Visual Acuity and Patient Satisfaction Results With A New Trifocal Diffractive IOL

Dr Anil Arora

Central Coast Optometrist Conference 2nd March 2014

Introduction• The aim of the study was to evaluate the visual

acuity outcomes and patient satisfaction results of a new diffractive trifocal intraocular lens.

• 32 patients underwent bilateral implantation with the AT LISA 839MP (Carl Zeiss Meditec)

• Patients had their unaided distance, intermediate and near vision measured at about 8 to 12 weeks post-op and were asked to complete a questionnaire on post-op spectacle independence, ocurence and severity of glare and haloes and overall satisfaction

Background

•Significant concern still exists about the potential negative side effects of multifocal IOL implantation – glare, haloes, loss of contrast sensitivity and quality of vision

•Currently estimates by companies producing multifocal IOLs are that less than 10% of ophthalmologists in Australia are implanting them or offering them to patients

Background• Previous diffractive multifocal IOLs have

generally had a bifocal design with incoming light being split into near and distance foci

• Many tasks, especially the use of computers, require good intermediate vision.

• Many patients who have had implantation with bifocal diffractive MFIOLs , whilst generally being happy with the result, have needed to wear +1 or +1.5 readers for good intermediate vision (eg. working on the computer, labels and prices on supermarket shelves, dashboard of the car).

Concerns with multifocal IOLs• Multifocals takes too much chair time which I don't have to spare • I have seen unhappy multifocal patients in the past • Multifocals significantly reduce contrast sensitivity • Patients like wearing reading glasses• Monovision is just as good and easier• I heard you need to touch up with a LASER in 30% of cases - I don't have

access to a laser• All my monofocal patients are happy• What if I need to explant - are these rates high?• I am worried about picking the wrong patient (personality)• What about the 6/6 N5 unhappy patient - do these happen and how do I

council them?• What happens if they develop AMD in the future?• Splitting light is not going to work....• I don't see the benefit in using multifocals only the downsides!!!!!!• Patients with multifocal IOLs still need glasses for intermediate tasks like

computer work or seeing prices on supermarket shelves

The intraocular lens•AT Lisa 839MP•Preloaded•Single-piece trifocal diffractive• MFIOL•6.0 mm biconvex optic with an• overall length of 11mm•Hydrophilic acrylic IOL with a• hydrophobic surface•Diffractive rings cover the entire• optic diameter

The intraocular lens•Central 4.34mm trifocal zone•Peripheral bifocal zone from 4.34 – 6.00

mm•Fewer rings on the optic surface compared

with its bifocal MFIOL predecessor to reduce risk

of visual disturbances•Aspheric optic to correct for corneal spherical aberration. Q value – 0.18 um.

LISA – more than just a pretty name

• L Light distributed asymmetrically between distant (50%), near (30%) and intermediate (20%) focus

I Independency from pupil size due to high performance diffractive- refractive micro-structure covering the complete 6.0 mm optical diameter

S SMP technology for a lens surface without any sharp angles for ideal optical imaging quality with reduced light scattering

A Aberration correcting optimized aspheric optic for better contrast sensitivity, depth of field and sharper vision

100 %

30 %

NEAR

50 %

FAR

20 %INTERMEDIATE

Light distribution

Light transmittance – about 85-87% irrespective of pupil size

Appearance in the eye

The study

•64 eyes of 32 bilaterally implanted patients (some results only available for 30 of these patients – 60 eyes)

•November 2012 – Nov 2013•Part of an ongoing study comparing the

Zeiss 839MP trifocal multifocal IOL to the Alcon ReSTOR 3.0 bifocal multifocal IOL

Visual acuity testing• Visual acuity checked • Monocular and

binocular unaided visual acuity tested at▫ - 6metres▫ - 80cm▫ - 40cm

Patient satisfaction survey• Patients asked to complete a

questionnaire on :• Subjective quality of vision

before and after surgery for distance, intermediate and near

• Incidence of glare and halos before and after surgery

• Impact of glare and halos on daily life

• Spectacle dependency before and after surgery for distance, intermediate and near

• Would you have it again and would you recommend it to a friend?

Patient survey• Generally given to

patients at about one month after second eye surgery

• Quality of unaided vision graded subjectively from excellent to poor before and after surgery for distance, intermediate and near

• Incidence of halos and glare and spectacle dependency graded never, sometimes or regularly before and after surgery

Painstaking analysis of results• Thorough double-checking

by the doctor to ensure accuracy of nurse’s measurements

Results

Visual acuity results

Monocular unaided near visual acuity

N5 or better89%

N611%

UCVA Reading n = 60 eyes

Binocular unaided near visual acuity

N5 or Better N60

5

10

15

20

25

30

Binocular UCVA Reading n = 30 Patients 28 patients N5 or better, 2

patients N6

Monocular unaided intermediate visual acuity

6/12 6/9 6/7.5 6/60

5

10

15

20

25

UCVA Intermediate VA @ 80 cm n= 60 eyes

Series1

Binocular intermediate visual acuity

6/12 6/9 6/7.5 6/6 or better0

2

4

6

8

10

12

14

Binocular Intermediate UCVA n = 30 patients

Series1

Monocular unaided distance visual acuity

6/12 6/9 6/6 6/5 or better0

5

10

15

20

25

30

Distance UCVA n = 30 patients n = 60 eyes

Binocular unaided distance visual acuity

6/9 6/6 6/5 or better0

2

4

6

8

10

12

14

16

18

20

Binocular UCVA Distance n = 30 patients

Monocular unaided distance visual acuity

5

16

79

Unaided distance visual acuity 6/6 0r better in 47/60eyes (79%), 6/9 in 10/60 eyes (16%) and

6/12 in 3/60 eyes (5%)

6/12 6/9

6/6 or better

Reasons for unaided visual acuity of 6/9 or worse

Uncorrected cylinder Macular Hole Dry Eyes Unknown - No refraction performed0

1

2

3

4

5

6

7

7

1

2

3

VA 6/9 or worse

Results

Patient satisfaction results

Unaided distance visionN = 32 Pre-op Post-op

Excellent 0 18

Very good 1 10

Good 10 3

Fair 12 1

Very poor 9 0

Unaided near visionN = 32 Pre-op Post-op

Excellent 2 15

Very good 0 14

Good 1 3

Fair 3 0

Very poor 26 0

Unaided intermediate visionN = 32 Pre-op Post-op

Excellent 0 16

Very good 1 12

Good 3 3

Fair 13 0

Very poor 15 1

Photic phenomena – glare, halos and starburstsN = 32 Pre-op Post-op

Never 18 2

Sometimes 8 19

Regularly 4 11

Photic phenomena

When do you notice them?At night (night driving ) 28 In bright light 8 In artificial light 7

Photic phenomena

Do they bother you?Never 16Sometimes 14Regularly 2

Asked at about 1month post-op

•Knowing what you know now about halos and glare, and knowing the reduced dependence you have on glasses after surgery, would you have the same type of IOL again and would you recommend it to a friend?

•31/32 said yes

Contrast sensitivity testing• Not carried out in our

study• Carried out by others and

shows a high degree of contrast sensitivity, similar to that of a 30 year old phakic patient

Contrast Sensitivity results for the AT LISA 839MP(courtesy of Dr Peter Mojzis)

1,5 3 6 12 181

10

100

1000

Reference RangeLISA 839M (tri-focal)LISA 809M (bifocal)Phakic

Spatial Frequency [CPD]

Cont

rast

sen

sitiv

ity

Contrast Sensitivity: Ginsbergh Box Courtesy of Dr Detlev Breyer

36

Photopic Mesopic

Age (years): Phakic: 31 ± 10; LISA 839M® (trifocal): 63 ± 9; LISA 809M® (bifocal): 72 ± 5

Photopic conditions: almost juvenile phakic-like results

1,5 3 6 12 181

10

100

1000

Reference RangeLISA 839M (tri-focal)LISA 809M (bifocal)Phakic

Spatial Frequency [CPD]

Cont

rast

Sen

sitiv

ity

0.0

2.0

4.0

6.0

8.0Pupil Diameter

Diam

eter

[mm

]

0.01.02.03.04.05.06.07.08.0

Pupil Diameter

Diam

eter

[mm

]

37

-5-4-3-2-10120.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40LISA 839M LISA 809M

Defocus [D]

-0.26

-0.20

-0.15

-0.08

±0.00

+0.10

+0.20

+0.40

+0.70

logMAR Decimal visual acuity

Defocus curves for LISA 809 and 839

LISA 839M® shows increased plateau at 70 cm (-1.5 D Defocus) Far- & near visual acuity show the same high level as the previous MIOL generation LISA 809M® High level intermediate visual performance without loss of far- or near distance visual quality

Defocus results of LISA839® by CZM

Defocus curves of Alcon ReSTOR IOLs

39

-5-4-3-2-10120.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

LISA 839M LISA 809M

Defocus [D]

-0.26

-0.20

-0.15

-0.08

±0.0

+0.10

+0.20

+0.40

+0.70

logMAR

Best of both worlds in one lens? 839 has the same logMAR values (about+0.05) as the Alcon ReSTOR +2.5 at about 70cm (-1.5 D, intermediate) and the ReSTOR +3.0 at about 40cm (-2.5D, near).

Who do I implant MFIOLs in?• Patients who are 50+ years old and very keen to

be spectacle or contact lens independent (often present requesting laser vision correction)

• Patients who understand that there will be glare and halos and that these lenses have limitations but are ready to accept this for spectacle independence (realistic expectations – lots of pre-op discussion)

• More “younger” presbyopic patients (40+) are starting to ask about MFIOL over LASIK as they can see the upside of not having to worry about cataract surgery in the future with MFIOL.

Unhappy patients and need for further intervention• No AT LISA 839 IOLs explanted so far!• Only one patient unhappy with IOL result and would

not have a MFIOL again or recommend it. He completed the survey at about one month post-op and was contacted recently at 9 months post-op and much happier about it now.

• One patient with ocular surface issues. 6/6 and N5 vision but “hazy”, “foggy”. Trying Restasis.

• 2 patients have had LASIK for correction of post-op refractive errors that were limiting unaided VA

• Some patients with less than perfect vision (13 out of 60 eyes had 6/9 -6/12 unaided) but still very happy. Many of these due to pre-op astigmatism that persisted post-op. At LISA 939 trifocal toric now available for these patients.

Conclusion• Very good visual acuity and patient satisfaction results.• Fantastic near vision results – all N6 or better, 93%N5 or better • True intermediate distance clarity.• Contrast sensitivity within normal range according to studies from

Europe.• Virtually every patient does get halos and glare but 50% are

“never” bothered by it and another 45% are only “sometimes” bother by it. 6% regularly bothered by photic phenomena.

• 12/32 patients had photic phenomena either sometimes or regularly pre-operatively. Many monofocal IOL patients troubled by glare post-op.

• Having experienced the “downside” of photic phenomenon, even without much time for neuroadaptation, almost all patients would have the same IOL again and would recommend it to a friend because of what they feel is the far greater “upside” of spectacle independence, or al least greatly reduced spectacle dependence.

MCQ’s• Q1) Multifocal or accommodating IOLs use the

following methods to reduce spectacle dependence except: a) Having a diffractive grating on the IOL surface to create separate images on the retinab) Having zones of different refraction to create separate images on the retinac) Being able to move slightly forwards within the eye when focussing at neard) Altering the retinal and optic nerve processing of the images that reach the retina

MCQ’s• Q2) Concerns that ophthalmologists and

optometrists have with multifocal IOLs include all of the following except: a) they are associated with haloes and glareb) they may reduce contrast sensitivity as compared with a monofocal IOLc) they increase the risk of postoperative dry eyed) they are sometimes associated with "waxy" or "foggy" vision

MCQ’s• Q3) The main advantage of a trifocal multifocal IOL over the

traditional bifocal multifocal is: a) the trifocal comes in a choice of coloursb) the trifocal provides better intermediate vision for tasks such  a working on the computerc) the trifocal produces x-ray vision for looking through solid objectsd) with the trifocal lens one does not need the specia glasses to watch 3-D movies 

Answers

•Correct answers: Q1 - d, Q2 - c, Q3 - b