Clinical and simulation outcomes of a multifocal intraocular lens with rotational asymmetry and two different levels of near addition

Jorge Alió, MD,PhD1,2

Luis J Moreno, MSc1,2

Ana B Plaza, MSc1

David P Piñero, PhD1

1VISSUM Corporation. Alicante.2Department of Pathology and Surgery. University Miguel Hernández, Alicante.

Abbott Medical Optics DAcuFocus DAkkolens A, DAlcon Laboratories DBausch & Lomb A, DCarl Zeiss Meditec DChemedica DEyemaginations AIndex Instruments PIntraLase Corporation DLenSx A,DMediphacos ANovagali Pharma DNulens D, POculentis A, DOSN/SLACK APresbia ASCHWIND eye-tech-solutionsD, ESpringer PTekia PThea D

Financial Disclosure for Jorge Alió, MD,PhD

PURPOSE: To evaluate and compare the visual acuity outcomes of a multifocal intraocular lens with rotational asymmetry and two different levels of addition and correlate these outcomes with computer simulations at different distances. Clinical results are compared with mathematical simulations.

SETTING: Vissum Corporation, Alicante, Spain

METHODS: 43 consecutive eyes of 26 cataract patients (age range 55-83 years) were divided into two groups: group A, 22 eyes implanted with the Lentis Mplus LS-312 MF15 IOL (Oculentis); group B, 21eyes implanted with the Lentis Mplus LS-312 MF30 IOL (Oculentis). Distance, near and intermediate visual acuity outcomes were evaluated preoperatively and postoperatively during a 6-month follow up.Additionally, postoperative contrast sensitivity, patient satisfaction, ocular aberrations, ocular optical quality and defocus curve were analyzed.

Clinical and simulation outcomes of a multifocal intraocular lens with rotational asymmetry and two different levels of near addition

LENTIS Mplus LS-312 MFMplus IOL is built virtually. Curvature data and asphericity are estimated.The mathematical analysis has been performed in Vissum Alicante, Spain.

Distance zone

Near zone

We used Navarro eye model and thought a ray tracing we chose the power of the Mplus IOL that minimized the size of far focus

Retina

Sclera

IrisLight

Pupil

Light for far focus

Light for near focus

Mathematical simulations

Size of focus in the retina as a function of Mplus Power

0

20

40

60

80

100

120

140

160

180

10 10,5 11 11,5 12 12,5 13 13,5 14 14,5 15 15,5 16 16,5 17 17,5 18 18,5 19 19,5 20

Diotric Power (D)

Siz

e o

f fo

cus

in r

etin

a (m

icro

ns)

We used Mplus with 15.5 diopters because it provided the best focus out of all the different powers available in today’s market.

We compared two versions of Mplus: LS-312 MF15 with 1.5 diopters of addition and LS-312 MF30 with 3.0 diopters of addition.Optical quality was computed as the size of the focus (in microns, μm) in the retina. The smaller the focus, the better the optical quality was.For distance vision (6m / 20′), both versions gave the same optical quality. For intermediate vision (80cm / 2′8′′) the version with 1.5 diopters gave more optical quality, whereas for near vision (40cm / 1′4′′), the version with 3.0 diopters gave more optical quality.

 

Object Position Distance Vision

6 metres / 20′

IntermediateVision

80 cm / 2′8′′

NearVision

40 cm/ 1′4′′

1,5 Diopters of additionLS-312 MF15

Main Focus(distance) 15 μm 39 μm 78 μm

 Secondary focus(near addition) 47 μm 19 μm 38 μm

3 Diopters of additionLS-312 MF30

Main Focus(distance) 15 μm 39 μm 78 μm

 Secondary focus(near addition) 99 μm 62 μm 17 μm

Clinical resultsPreoperative Conditions:

Both groups were comparable. No significant differences were found among them.

Clinical results

6 months follow up:

There is no significant differences in Uncorrected Distance Visual Acuity (LogMAR UDVA).However, the group A (+1.5) showed a better uncorrected intermediate visual acuity (LogMAR UIVA) than group B (+3.0) and group B showed a better uncorrected near visual acuity (LogMAR UNVA) than group A

Lentis Mplus LS-312 MF15Better visual acuity for defocus levels of +1.50, +2.0 and +2.5 D (Mann-Whitney test, p0.04).

Lentis Mplus LS-312 MF30Better visual acuity for defocus level of -0.50 D (Mann-Whitney test, p=0.03).

Good vision with +1.5, +2.0 and +2.5 D of defocus is in relation with intermediate and distance vision. This better intermediate visual function was consistent with the better values of UIVA obtained.On the other hand, the +3.0 D of addition IOL was found to provide a better visual outcome for a level of defocus of –0.5 D, which was in relation with the ability of seeing sharply at distances less than 33 cm (near vision).

Defocus curve

Lentis Mplus LS-312 MF30 and MF15 IOLs are able to restore successfully the distance visual function after cataract surgery and to provide an improvement in intermediate vision, with also a complete near visual rehabilitation with the MF30 model.

Lentis Mplus LS-312 MF30 and MF15 IOLs provides a excellent distance vision.

LS-312 MF30 provides a better visual acuity for near distance than LS-312 MF15, however LS-312 MF15 provides a better visual acuity for intermediate vision than LS-312 MF30. Clinical results are consistent with mathematical simulations.

Conclusions

Luis J Moreno MsC

David Piñero PhDAna Belén Plaza MSc

Jorge Alió, MD,PhD