comparison of visual performance of 2 diffractive trifocal … · 2020-03-26 · escrs marrakech...
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K. Stjepanek, J. Hienert, M. Ruiß, N. Hirnschall, O. Findl
Comparison of visual performance of 2 diffractive trifocal intraocular lenses: a randomised controlled trial
Vienna Institute for Research in Ocular Surgery (VIROS)Hanusch Krankenhaus, Vienna, Austria
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Financial Disclosure
ESCRS Marrakech 2020
Sponsored Clinical Trials & Unrestricted Grants to Institute (VIROS) in 2020:• Aerie• Alcon• Bausch + Lomb• Carl Zeiss Meditec AG• Cristalens• Croma Pharma
O. Findl - Scientific Advisor / Member of Scientific Advisory Board:• Alcon• Carl Zeiss Meditec AG• Croma Pharma• Johnson & Johnson Vision Care• Merck
Personal financial interest in products:• None
• Heidelberg Engineering• Johnson & Johnson Vision Care• Novartis• Oculentis• Rayner• Roche
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Trifocal IOLs
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Comparison of the two study lenses
ESCRS Marrakech 2020
RayOne Trifocal AT LISA tri 839 MP
4.5mm diffractivetrifocal zone
>4.5mm monofocal, distance
4.34mm diffractivetrifocal zone
>4.34mm bifocalzone
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Study design
• randomized, double-masked trial• 88 eyes of 44 patients
• one eye AT LISA tri 839 MP (Zeiss)• other eye RayOne Trifocal (Rayner)
− randomized assignment of IOL
ESCRS Marrakech 2020
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Inclusion criteria• Senile cataract
• Scheduled cataract surgery for both eyes
• Motivated to be less spectacle dependent
• ≥ 21 years
• Corneal astigmatism ≤ 1.5 D (keratometry, IOL Master)
Exclusion criteria• Pregnancy
• Retinitis pigmentosa, chronic uveitis, amblyopia
• Pupil misalignment > 1mm
• Previous LASIK / retinal surgery
ESCRS Marrakech 2020
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Methods
• Main outcome
• Change of uncorrected near visual acuity (UNVA)
• Secondary outcome
• Uncorrected and best corrected distant visual acuity (UCDVA, BCDVA)• Uncorrected and distance corrected intermediate visual acuity (UCIVA, BIVA)• Distance corrected near visual acuity (DCNVA)• Defocus curve• Salzburg reading desk• Aston halometer• Contrast sensibility in miosis and mydriasis• Quality of vision questionnaire
ESCRS Marrakech 2020
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Uncorrected VA
ESCRS Marrakech 2020
logM
ARn = 40
Ray One TrifocalAT LISA tri
p=0.707 p=0.460 p=0.327
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Distance corrected VA
ESCRS Marrakech 2020
logM
AR
p=0.527 p=0.519 p=0.193
n = 40Ray One TrifocalAT LISA tri
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RayOne Trifocal AT LISA tri
-4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2
Defocus curvelo
gMAR
diopters
p=0.167
p=0.016p=0.121
-0.10.0 0.10.20.30.40.50.6
ESCRS Marrakech 2020
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Salzburg Reading Desk
seco
nds
wor
dspe
r min
ute
p=0.633 p=0.258
ESCRS Marrakech 2020
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Aston Halometer
halo
-rad
ius
TRI018 ODAT LISA tri
TRI018 OS RayOne Trifocal
2.5
2.0
1.5
1.0
0.5
0.0
ESCRS Marrakech 2020
0° 45° 90° 135° 180° 225° 270° 315°
RayOne Trifocal AT LISA trip=0.434
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ESCRS Marrakech 2020
OPTEC 6500 Vision TesterPhotopic Mesopic
RayOneTrifocal AT LISA tri RayOne
Trifocal AT LISA tri
Miosis13.5 ( ± 5.9) 17.3 ( ± 7.4) 8.7 ( ± 4.7) 12.0 ( ± 4.9)
p= 0.493 p= 0.082
Miosis +Glare
14.1 ( ± 6.7) 16.2 ( ± 7.0) 4.6 ( ± 4.8) 5.2 ( ± 5,3)
p=0.808 p=0.790
Mydriasis9.0 ( ± 5.9) 12.3 ( ± 7,1) 6.8 ( ± 4.4) 9.6 ( ± 4.6)
p= 0.293 p= 0.297
Mydriasis +Glare
6.3 ( ± 5.7) 9.0 ( ± 7.5) 0.2 ( ± 1.0) 1.4 ( ± 2.5)
p= 0.691 p= 0.159
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Decentration
RayOne Trifocal AT Lisa tri
Mean 0.92 0.94
SD ± 0.32 ± 0.23
p = 0.465
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Tilt
RayOne Trifocal AT Lisa tri
Mean 3.09 3.20
SD ± 0.91 ± 0.94
p = 0.779
ESCRS Marrakech 2020
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Quality of vision
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Quality of vision
05
10152025303540
glarehaloes
starburst
s
hazy vision
blurred vi
sion
distorti
on
multiple im
ages
fluctu
ation of v
ision
focusin
g diffi
cultie
s
depth perceptio
n
never occasionally quite often very often
patie
nts
ESCRS Marrakech 2020
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Severity
05
1015202530
glare haloes starbursts hazy vision blurred visionnot at all mild moderate severe
patie
nts
ESCRS Marrakech 2020
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Bothersome
05
1015202530
glare haloes starbursts hazy vision blurred vision
not at all a little quite very
patie
nts
ESCRS Marrakech 2020
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Subjective Disturbance of Vision
ESCRS Marrakech 2020
-10 -8 -6 -4 -2 0 2 4 6 8 10
Subjective Distant Visual Acuity p=0,20
Subjective Intermediate Visual Acuity p=0,26
Subjective Near Visual Acuity p=0,37
Subjective Halo p=0,43
Subjective Glare p=0,63
Subjective Starbursts. p=0,34
Overall Disturbance p=0,67Ray One Trifocal AT LISA trin=23
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Conclusions
RayOne Trifocal showed…
• trend for slightly better UCNVA and DCNVA
• significantly better VA in intermediate zone in defocus curve
• no significant difference concerning dysphotopsia
ESCRS Marrakech 2020
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ESCRS Marrakech 2020
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