EPS technology for trifocalityVisual performance of patients implanted with trifocal Bi-Flex MYanalyzed by the Multifocal Lens Analyzer for iPad

Joaquín Fernández, MD@joaquinfernandezoftaboutme/drjoaquinfernandez

Qvision, Ophthalmology Department (Hospital Vithas Virgen del Mar)

Patient-centered evolution

Why Bi-Flex MY?

Marketing-centered evolution

Spectacle independence at near Intermediate vision

de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev [Internet]. 2016 Dec 12;(9).

“Energy cannot be created or destroyed, it can only be changed from one form to another”

Albert Einstein

Marketing evolve for the improvement of intermediatevision forgetting the main factor of the Multifocal IOL

success “spectacle independence”

EPS technology for trifocality

“The Elevated Phase Shift Technology (EPS) is a newapproach for improving intermediate vision maintaining theextended range of vision at near that ensures spectacleindependence”

Figure provided by

Intermediate constructive foci Extended Near RangeSlightly increased

Optical bench resultsEPS technology for trifocality

Figure provided by

Phase-shift

EPS technology for trifocality

Clinical Evidence

“Conventional methods based on visual acuity at three particulardistances (far, intermediate and near) do not completely describe the

clinical performance of a MIOL. Area under visual acuity defocuscurves is a better descriptor of visual performance”

“The Multifocal Lens Analyzer App enables the fast measure ofdefocus curves and the Big Data for this metric”

CDAVCDSC

INTRODUCTION to MLA

METHODS

41 eyes without any complication9 eyes with complications

6 eyes with anterior capsule tear

3 eyes with corneal erosion

25 implanted subjects

Complications or Adverse Events not related with the IOL

5 men and 20 womenMean age 69.7 ± 7.4 [56 to 83]Corneal astigmatism ≤ 0.75 D

METHODS

41 eyes without any complication9 eyes with complications

6 eyes with anterior capsule tear

3 eyes with corneal erosion

25 implanted subjects

Complications or Adverse Events not related with the IOL

5 men and 20 womenMean age 69.7 ± 7.4 [56 to 83]Corneal astigmatism ≤ 0.75 D

METHODS

1 month follow-upMonocular standardized reportsBinocular defocus curves with MLA

3 month follow-upMonocular defocus curves with MLAFactors for optimizing the performance

Eyes with complicationswere excluded from the analysis

ACCURACY or PREDICTABILITY

Kane JX et al. J Cataract Refract Surg. 2016;42(10):1490-1500.

Comparison 7 equations

OLCI OLCR

Cooke DL, Cooke TL. J Cataract Refract Surg. 2016;42(8):1157-1164.

Mean Lax 23.81 mm; from 20.87 to 29.44 mm; N=1079

No lens thickness Lens thickness

PhacoOptics

Mean ~ 0.40 D

± 0.5 D: 75.1%

Comparison 9 equations

1 month

ACCURACY or PREDICTABILITY

Comparison 9 equations

Adjusted to intended refraction

mean ± sd-0.15 ± 0.33

median (iqr)0 (0.23)

* Manifested spherical equivalent – Target spherical refraction

SRK-T 1 month

Refractive cylinder after surgery

EFFICACY (monocular far distance) 1 month

mean ± sd0.10 ± 0.16

median (iqr)0.1 (0.13)

mean ± sd0.00 ± 0.08

median (iqr)0.00 (0.03)

UDVA

CDVA

Far distance

EFFICACY (monocular intermediate distance) 1 month

mean ± sd0.20 ± 0.14

median (iqr)0.2 (0.2)

mean ± sd0.22 ± 0.16

median (iqr)0.2 (0.2)

UIVA

CIVA

67 cm of distance

EFFICACY (monocular near distance) 1 month

mean ± sd0.09 ± 0.10

median (iqr)0.1 (0.1)

mean ± sd0.08 ± 0.10

median (iqr)0.1 (0.1)

UNVA

CNVA

40 cm of distance

EFFICACY (lines of difference Uncorrected vs Corrected) 1 month

Distance Intermediate Near

Good tolerance to the residual refractive error at 67 cm and 40 cm

Comparison with published results 3 month

50 eyes of 25 patientsMean age was 66.3 ± 7.7 years

mean ± sd0.13 ± 0.130.10 ± 0.16

0.20 ± 0.14

0.09 ± 0.10

mean ± sd0.00 ± 0.080.00 ± 0.08

0.22 ± 0.160.28 ± 0.09

0.08 ± 0.100.13 ± 0.08

Distance

Intermediate

Near

Distance uncorrected Distance corrected

3.25 ± 0.69 mm in photopic4.58 ± 0.73 mm in mesopic

What we have learnt from VADC?

Trifocal (EPS)Bi-Flex M 677MY

Better performance in eyes with less corneal power and slight temporal (~0.3mm) decentration versus vertex normal improves intermediate

Monocular defocus curves correlations 3 month

• Visual Acuity Defocus CurveArea under the curve above 0.3 logMAR

Distance Intermediate Near Total

Intraocular lens position after surgery

Shoji T, Kato N, Ishikawa S, et al. In vivo crystalline lens measurementswith novel swept-source optical coherent tomography : an investigationon variability of measurement. 2017:1-8.

Bi-Flex centers over the normalposition of the Crystalline Lens

Crystalline Lens

Bi-Flex M

Monocular defocus curves correlations

Shoji T, Kato N, Ishikawa S, et al. In vivo crystalline lens measurements with novel swept-source optical coherent tomography : an investigation on variabilityof measurement. 2017:1-8.

Crystalline LensBi-Flex MW-60

Visual Performance is optimized atthe natural position of thecrystalline lens

IOL decentration versus pupil center 3 month

It will be added a (-) sign when the decentration is temporal or superior, or a (+) sign when the decentration isnasal or inferior. The decentration will be established horizontally and vertically (H, V) following a 5 level ordinalscale which is described below:• 0, the lens is placed centered• 1, the lens is 25% decentered• 2, the lens is 50% decentered. In this case the pupil centre corresponds to the edge of the first ring• 3, the lens is placed 75% decentered. The pupil center corresponds to the second ring edge• 4, the vertical fringe passing through the pupil center goes beyond the second ring

Q-MIOLC Scale

IOL decentration versus pupil center 3 month

15 % Nasal decentatrion ~ 0.3 mm

40% Close to pupil center < 0.3 mm

45% Temporal decentration ~ 0.3 mm

RE

RE

RE

15% Superior decentration ~ 0.3 mm

45% Close to pupil center < 0.3 mm

40% Inferior decentration ~ 0.3 mm

HORIZONTAL VERTICAL

IOL decentration versus pupil center 3 month

RE

RE

RE

HORIZONTAL VERTICAL

CenteredNasal Temporal

Inte

rmed

iate

AUC

Inte

rmed

iate

AUC

CenteredInferior Superior

Intermediate vision enhancement with slight temporaldecententration versus pupil center / vertex normal

Defocus curves 3 month

García-Bella J, Ventura-Abreu N, Morales-Fernández L, et al. Visual outcomesafter progressive apodized diffractive intraocular lens implantation. Eur JOphthalmol. 2018;28:282-286.D

Binocular n = 26

Fernández J, Rodríguez-Vallejo M, Martínez J, et al. Biometric Factors Associated with theVisual Performance of a High Addition Multifocal Intraocular Lens. Curr Eye Res. May2018:1-8.

Photopic: 2.60 ± 0.49 mm Mesopic: 3.99 ± 0.68 mm Photopic: 3.25 ± 0.69 mm Mesopic: 4.58 ± 0.73 mmAge: 67.6 ± 7.9 years Age: 66.3 ± 7.7 years

Topcon KR-1 W.Keratograph 5M

Dysphotopic phenomena 3 month

0 = no trouble; 1 = minimal trouble; 2 = moderate trouble; 3 = considerable trouble; 4 = overwhelming trouble

(Glare)

(Halo)(Starbust)

(Halo+Starbust)

García-Bella J, Ventura-Abreu N, Morales-Fernández L, et al. Visual outcomes after progressive apodized diffractive intraocular lens implantation. Eur J Ophthalmol.2018;28:282-286.D

Conclusions

Predictability: mean spherical equivalent residual error of -0.15 ± 0.33 Dand 88% of eyes in ± 0.50 D

Monocular Efficacy: logMAR Far Intermediate NearUncorrected 0.1 0.2 0.09

Corrected 0.0 0.2 0.08

The intermediate and near vision remain almost similar with and withoutbest correction

Binocular defocus curves were around one line of visual acuity better thanmonocular defocus curves.

Younger patients achieved better results in terms of visual acuity defocus curves.