clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65%...

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Clinical outcomes, astigmatism- correction and rotational stability after the implantation of the Medicontur Bi-flex 677TAY toric intraocular lens MuDr. Iveta Nemcova Klinické Centrum ISCARE Holešovice, Čechy

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Page 1: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Clinical outcomes, astigmatism-

correction and rotational stability

after the implantation of the

Medicontur Bi-flex 677TAY

toric intraocular lens

MuDr. Iveta Nemcova

Klinické Centrum ISCARE

Holešovice, Čechy

Page 2: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

87% 65% 22%

87% of cataract surgery patients

had preoperative astigmatism

In 65%, corneal astigmatism was

between 0.25 and 1.25 D

22% of eyes had astigmatism

greater than 1.50 D

According to many demographics studies most patients with cataract have corneal astigmatism as well.

The study by Ferrer-Blasco including 4,540 eyes has reported, that:

Ferrer-Blasco T, Montés-Micó R, Peixoto-de-Matos SC, González-Méijome JM, Cerviño A. Prevalence of corneal astigmatism before cataract

surgery. J Cataract Refract Surg. 2009;35(1):70-5.

Astigmatism in cataract patients

Page 3: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

3

1. Spectacles and contact lenses

2. Limbal Relaxing Incisions (LRI)

3. Laser correction surgeries

4. Corneal ring

5. Intraocular lenses (toric, cylindric)

Astigmatism - Correction

Page 4: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Experiences with the

Medicontur Bi-Flex 677TAY

toric IOLs

A prospective study including

22 patients (35 eyes)

Page 5: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Study design

• Prospective, non-comparative

• 22 patients → 35 eyes (mono- or binocular implantation)

• Conventional cataract surgery (phacoemulsification followed by monofocal toric IOL implantation)

- In case of binocular surgery, the fellow eye was implanted XX weeks after the surgery of

the first eye

• Follow-up visits:

• Measurements, examinations (both pre- and postop.)

- Visual acuity (UCDVA, BCDVA, BCNVA)

- Autorefractometry

- IOP

- IOL position

- Biometry (preop.)

Preop Day 1 Day 7 Month 2Month 1 Month 3

Page 6: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

• E X C E L L E N T R O TAT I O N AL S TAB I L I T Y

- Stable also in long eyes (25< mm)

• L O W P C O R AT E

- Perfect 360° SE (<10um)

• W I D E S T C Y L I N D R I C AL R AN G E

- Concave-convex technology

• O P T I M AL C O N T R A S T S E N S I T I V I T Y

- Low chromatic aberration

- Natural yellow filter

• P R E L O AD E D M O D E L

• T h e M E D I C O N T U R I O L O P T I M I Z E R

- Haigis + Abulafia-Koch Formula, taking full

corneal power into consideration

H Y D R O P H I L I C A C R Y L I C , M O N O F O C A L T O R I C I O L

Bi-Flex 677TAY IOL by Medicontur

h t t p s : / / t o r i c c a l c u l a t o r . n e t / # / m a i n

Page 7: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

P R O D U C T S P E C I F I C A T I O N S

Bi-flex 677TAY IOL by Medicontur

Page 8: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Demographic of the patients

Demographic Mean ± SD Range

Age (y) 67.0 ± 4.5 58 - 74

Gender (n)

Female 14 (63.6%)

Male 8 (36.4%)

AXL (mm) 23.22 ± 1.20 21.22 – 25.92

ACD (mm) 2.97 ± 0.50 1.85 – 4.03

K1 (D) 42.82 ± 1.87 40.13 – 47.14

K2 (D) 44.43 ± 2.08 40.42 – 48.73

CYL (D) -1.47 ± 1.27 -4.50 – 1.50

SEQ (D) 1.11 ± 2.74 -6.25 - +5.75

UCDVA (decimal) 0.32 ± 0.18 0.01 – 0.60

BCDVA (decimal) 0.65 ± 0.16 0.15 – 0.90

UCNVA (decimal) 0.31 ± 0.22 0.00 – 0.90

BCNVA (decimal) 0.77 ± 0.24 0.00 – 1.00

IOP (mmHg) 15.6 ± 3.05 11.0 – 25.0

Page 9: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Implanted IOLs

15.0 15.5 16.0 16.5 17.0 17.5 18.0 18.5 19.0 19.5 20.0 20.5 21.0 21.5 22.0 22.5 23.0 23.5 24.0 24.5 25.0 25.5 26.0 26.5 27.0 27.5 28.0

0

1

2

3

4

5

6

IOL SEQ (Dioptres)

Nu

mb

er

of

IOL

s

1 1.50 2.25 3.00 3.75

0

2

4

6

8

10

12

14

16

IOL cylinder (Dioptres)

Nu

mb

er

of

IOL

s

Page 10: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Clinical results

Visual outcome, Predictability,

Efficacy, Stability

Page 11: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Implantation is safe

Preop D1 D7 M1 M2 M3

0

5

10

15

20

25

IOP

(m

mH

g)

• No complcations or adverse events occured

during the surgery or the follow-up period

• Intraocular pressure is stable

• Biomicroscopic and fundoscopic evaulations

show normal conditions

• Day 1 and Day 7: 9 and 5 eyes showed corneal

edema, which vanished until the next visit

• 3 month after surgery, 2 eyes of the same

patients were diagnosed with age-related

macular degeneration (AMD). This patient was

excluded from the analysis.

• 2 patients were found to have dry-eye

syndrome at the 3 months follow-up visit

Page 12: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Distance vision improved, results are close to the best achievable

Page 13: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Distance vision improved, less correction is needed

Preop M3 Preop M3

-10

-8

-6

-4

-2

0

2

4

6

Co

rrec

tio

n (

Dio

ptr

es)

SPH CYL

Mean SD n Mean SD n Mean SD n

Preop 0.68 0.14 12 0.38 2.56 12 -1.79 1.20 12

M3 0.98 0.04 12 0.00 0.35 12 0.32 0.20 12

Δ Correction -0.43 2.68 11 -1.55 1.07 11

BCDVA SEQ CYL

Page 14: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Near vision is improved

Preop M1 M2 M3

0.0

0.2

0.4

0.6

0.8

1.0

1.2

Vis

ua

l A

cu

ity

(d

ec

ima

l) BCNVA

Mean SD n

Preop 0.77 0.24 35

M1 0.98 0.06 25

M2 1.00 0.02 20

M3 0.98 0.07 35

BCNVA

Page 15: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Bi-Flex 677TAY toric IOLs are efficient in correcting both refractive errors

and astigmatism

Preop

Month 3

Page 16: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Results are predictable (calculations are precise)

Predicted Actual (M3)

-2.0

-1.5

-1.0

-0.5

0.0

0.5

1.0

1.5

2.0

Co

rrec

tio

n (

Dio

ptr

es) SEQ

CYL

Mean SD n Mean SD n

Predicted -0.04 0.15 35 0.28 0.24 35

Actual (M3) -0.16 0.33 35 -0.44 0.28 35

SEQ CYL

-0.4 -0.2 0.0 0.2 0.4

-1.0

-0.8

-0.6

-0.4

-0.2

0.0

0.2

0.4

0.6

0.8

1.0

Predicted SEQ

Actu

al S

EQ

Y = 0.5697*X - 0.1352

Page 17: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Refractive stability is confirmed

Preop D1 D7 M1 M2 M3

-4

-3

-2

-1

0

1

2

3

4

Dio

ptr

es

SPH

CYL

SEQ

Mean SD n Mean SD n Mean SD n

Preop 1.11 2.74 34 -1.47 1.27 32 0.42 2.60 34

D1 0.19 0.65 22 -0.85 0.69 22 -0.24 0.46 21

D7 0.36 0.65 20 -0.43 0.26 19 0.14 0.58 23

M1 -0.02 0.31 26 -0.57 0.43 26 -0.30 0.39 26

M2 0.02 0.27 22 -0.39 0.58 22 -0.17 0.43 22

M3 0.06 0.29 35 -0.44 0.28 35 -0.16 0.33 35

SPH CYL SEQ

Page 18: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Astigmatism correction is predictable and efficient

Error in CYL(Pred. vs. Actual)

-3

-2

-1

0

1

2

3

Dip

otr

es

Reduction in CYL(Preop vs. M3)

-6

-4

-2

0

2

4

Dip

otr

es

0.18 ± 0.37 D -1.01 ± 1.28 D

Page 19: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

LO:GO

Rotation is minimal → Excellent rotational stability is confirmed

D1 D7 M1 M2 M3

0

2

4

6

8

10

Ro

tati

on

(°)

D1 D7 M1 M2 M3

0

2

4

6

8

10

Ro

tati

on

(°)

There was no rotation of more than 5°

during the first 3 postoperative months

Signed values

Absolute values

Page 20: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Conclusions and Take Home Messages

2

3

4

1

Safe implantationNo complications or avderse events suring or after

the surgery

Efficient correction of refractive

errors and astigmatismRefractive results are close to target.

Predictable outcomeActual refractive results are close to those estimated by the

Medicontur IOL Optimizer prior to surgery.

Refractive and Rotational StabilityDuring the 3-months follow-up no refractive shift or any off-axis rotation

exceeding 5° occurred.

Page 21: Clinical outcomes, astigmatism- correction and rotational stability … · 2020-02-12 · 87% 65% 22% 87% of cataract surgery patients had preoperative astigmatism In 65%, corneal

Thank you for your

kind attention!