comparison of two multifocal iol types –short and medium ... · comparison of two multifocal iol...
TRANSCRIPT
Comparison of two multifocal IOL
types – short and medium-term
visual outcomes
Semmelweis University, Department of Ophthalmology
Budapest, Hungary
Head: Prof. Zoltan Zsolt Nagy
AF Dunai, K Kranitz, E Juhasz, G Sandor, T Filkorn,
ZZs Nagy
SEMMELWEIS EGYETEM
SZEMÉSZETI KLINIKA
Authors’ travel and certain aspects of
study were financed by
Medicontur, Geneva, Switzerland.
SEMMELWEIS EGYETEM
SZEMÉSZETI KLINIKA
Aim
• To compare the refractive and visual outcomes collected
during the first six postoperative months after the
implantation of two types of different one-piece acrylic
diffractive multifocal intraocular lenses (IOL).
SEMMELWEIS EGYETEM
SZEMÉSZETI KLINIKA
Patients
• Prospective randomised study• Crystalline lens extraction, 100 eyes of 50 patients• Indication: partly age-related cataracts, partly refractive lens
exchanges (RLE)
• Motivated patients, informed consent• Exclusion criteria:
• Any, potencially vision-resctrictive eye diseases• Preoperative refraction: more than +/- 6.0D spherical or
1.0D torical• Any intraoperative complications
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Patients
• Group A: 50 eyes of 25 patients• Medicontur Bi-Flex 677MY• PAD (Progressive Apodized
Diffractive) technology
• Group B: 50 eyes of 25 patients• Alcon Acrysof Restor SN6AD1• Diffractive multifocal technology
• Randomised study groups
http://www.reviewofoptometry.com/
http://www.medicontur.com
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Pre- and postoperative examinations
• Uncorrected and corrected ETDRS LogMAR visual acuity (VA)
• Far (UDVA, CDVA)• Intermediate (UIVA, CIVA)• Near (UNVA, CNVA)
• Autorefractometry• MRK-3100P, Huvitz Co., Gunpo-si Gyeonggi-do, Rep. of Korea
• Manifested refraction
www.intechopen.com
http://www.medwow.com
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Optical biometry
• IOL planning• Lenstar LS900; Haag-Streit AG, Koeniz, Switzerland
• Multi formula
• Postoperative follow-up of thebiometric parameters
http://haag-streit-usa.com
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Surgical technique
• 3 experienced surgeons (ZZsN, AD, TF)• Same instruments and surgical technique• Superior incisions (90-100°)• No intraoperative complications• In-the-bag implantations
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Postoperative examinations
• 1 day, 1 week, 4 weeks• 3, 6, 12, 24 months• Digital slitlamp photos in
retroillumination, dilatedpupil (IOL position)
• BQ 900® Haag-Streit AG, Koeniz, Switzerland
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Epidemiological and biometric data
Group A (MC 677MY) Group B (Restor) P*
Number of cases (patients) 50 (25) 50 (25)
Age (years) 65.0 ± 11.6 67.5 ± 9.4 0.547
Gender (male/female) 15/10 8/17
Preoperative far visual acuity
Non-corrected (UDVA, LogMAR) 0.51 ± 0.36 0.57 ± 0.35 0.492
Best corrected (CDVA, LogMAR) 0.14 ± 0.10 0.15 ± 0.20 0.626
Absolute value of preop. SE (diopters) 2.37 ± 1.82 1.88 ± 1.32 0.526
Preop. manifested astigmatism (diopters) 0.34 ± 0.42 0.26 ± 0.39 0.475
Spherical power of IOLs (diopters) 21.19 ± 4.61 22.28 ± 2.02 0.554
*: Mann-Whitney U test
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Non-corrected, monocular far visual
acuity (UDVA)
*: Mann-Whitney U test
Preop. 1st day 1st week 4th week3rd
month6th
month
BiFlex 677MY 0,51 0,16 0,09 0,03 -0,02 0,02
Restor SN6AD1 0,57 0,26 0,08 0,05 0,06 0,06
-0,1
0
0,1
0,2
0,3
0,4
0,5
0,6
ET
DR
S L
og
MA
RV
A 4
m
* *
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Non-corrected, monocular intermediate
visual acuity (UIVA)
*: Mann-Whitney U test
*
Preop. 1st day 1st week 4th week3rd
month6th
month
BiFlex 677MY 0,66 0,29 0,26 0,24 0,23
Restor SN6AD1 0,59 0,33 0,26 0,3 0,29
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
ET
DR
S L
og
MA
RV
A 8
0 c
m
*
SEMMELWEIS EGYETEM
SZEMÉSZETI KLINIKA
Non-corrected, monocular near visual
acuity (UNVA)
Preop. 1st day 1st week 4th week3rd
month6th
month
BiFlex 677MY 0,7 0,32 0,21 0,19 0,14 0,11
Restor SN6AD1 0,84 0,36 0,24 0,19 0,18 0,16
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
ET
DR
S L
og
MA
RV
A 4
0 c
m
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Non-corrected, binocular visual acuity
(UVA, LogMAR)
*: Mann-Whitney U test
Group A(BiFlex 677MY)
Group B(Restor SA6AT1)
P*
UDVA (3 months) -0.08 ± 0.10 0.01 ± 0.05 0.001
UDVA (6 months) -0.03 ± 0.04 -0.01 ± 0.04 0.217
UIVA (3 months) 0.10 ± 0.11 0.18 ± 0.07 0.026
UIVA (6 months) 0.12 ± 0.12 0.22 ± 0.08 0.011
UNVA (3 months) 0.07 ± 0.06 0.10 ± 0.07 0.305
UNVA (6 months) 0.02 ± 0.12 0.08 ± 0.09 0.217
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Absolute value of the manifested
spherical equivalent (preop vs 6 months)
Preop far6 months
far
Preop
intermed
6 months
intermed
Preop
near
6 months
near
BiFlex 677MY 2,37 0,09 2,8 1,28 3,3 0,14
Restor SN6AD1 1,88 0,17 2,82 1,55 3,61 0,15
0
0,5
1
1,5
2
2,5
3
3,5
4
Ab
s. v
alu
eo
f m
an
ife
ste
dS
E
(dio
pte
rs)
Wilcoxon test: significant change in every distances;*: Mann-Whitney U test; p= 0.008
*
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Defocus curve (bilateral, 3 months)
0
0,2
0,4
0,6
0,8
1
1,2
1,4
+4.0D +3.0D +2.0D +1.0D 0.00D -1.0D -2.0D -3.0D
ET
DR
S d
eci
ma
lV
A 4
m
BiFlex 677MY Restor SN6AD1
DISTANCE
NEAR
INTERMEDIATE (65 cm)
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Defocus curve (bilateral, 6 months)
0,00
0,20
0,40
0,60
0,80
1,00
1,20
1,40
+4.0D +3.0D +2.0D +1.0D 0.00D -1.0D -2.0D -3.0D
ET
DR
S d
eci
ma
lV
A 4
m
BiFlex 677MY Restor SN6AD1
DISTANCE
INTERMEDIATE (65 cm)
NEAR
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Area under the defocus curve
(bilateral, 6 months)
*: Mann-Whitney U test
Group A(BiFlex 677MY)
Group B(Restor SA6AT1)
Difference(%)
P*
AutC (+4.0D; -3.5D)(whole area)
5.51 ± 0.52 D 4.75 ± 0.54 D 16.0% 0.002
AutC (+1.0D; -1.0D)(far vision)
1.99 ± 0.19 D 1.83 ± 0.16 D 8.7% 0.025
AutC (-1.0D; -2.0D)(intermediate vision)
0.90 ± 0.20 D 0.70 ± 0.08 D 28.6% <0.001
AutC (-2.0D; -3.0D)(near vision)
0.96 ± 0.11 D 0.88 ± 0.11 D 9.1% 0.943
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Visual Functioning Questionnaires (VFQ)
Mann-Whitney U test: no significant difference between the two groups
0
0,5
1
1,5
2
2,5Glare/Flare
Night vision
Colour perception
Halos
Depth perception
Distorted near vision
Distorted far vision
Blurred near vision
Blurred far vision
Double vision
Visual complaints
Bi-Flex 677MY Restor SN6AD1
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Visual Functioning Questionnaires (VFQ)
Mann-Whitney U test: no significant difference between the two groups
0,00
0,50
1,00
1,50
2,00
2,50TV, movies
Working outside
Caring for children
Reading an alarm clock
Seeing clearly when…
Reading a wall clock
Work/hobbies
SportSocial eventsReading/near work
Driving at night
Driving in rain
Using a computer
Cooking
Shopping
Using mobile phone
Shaving/make up
Visual functions
Bi-Flex 677MY Restor SN6AD1
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Conclusion
• Multifocal IOL implantation is a well-calculable and efficient method for the cataract surgery of patients who wish to achieve spectacle independence.
• Similarly good near VA was found during thefollow-up of both IOL types.
• In Group A, superior uncorrected far and intermediate vision and better depth of focus was found three and six months after the surgery, compared to the patients in Group B.
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Conclusion
• For this reason, the Medicontur 677MY may be recommended for the patients for whom it is important to achieve:
– Fast visual rehabilitation after the surgery
– Excellent far and near visual acuity
– Good intermediate vision for different work distances
Thanks for your kind
attention!