Clinical and simulation outcomes of a multifocal intraocular lens with rotational asymmetry and two different levels of near addition Jorge Alió, MD,PhD 1,2 Luis J Moreno, MSc 1,2 Ana B Plaza, MSc 1 David P Piñero, PhD 1 1 VISSUM Corporation. Alicante. 2 Department of Pathology and Surgery. University Miguel Hernández, Alicante.

Abbott Medical Optics D AcuFocusD AkkolensA, D Alcon LaboratoriesD Bausch & LombA, D Carl Zeiss MeditecD ChemedicaD EyemaginationsA Index InstrumentsP IntraLase Corporation D LenSxA,D MediphacosA Novagali PharmaD NulensD, P OculentisA, D OSN/SLACKA PresbiaA SCHWIND eye-tech-solutionsD, E SpringerP Tekia P Thea 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 years) were divided into two groups: group A, 22 eyes implanted with the Lentis Mplus LS-312 MF15 IOL (Oculentis); group B, 21 eyes 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 MF Mplus 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 Iris Light Pupil Light for far focus Light for near focus Mathematical simulations

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 PositionDistance Vision 6 metres / 20′ Intermediate Vision 80 cm / 2′8′′ Near Vision 40 cm/ 1′4′′ 1,5 Diopters of addition LS-312 MF15 Main Focus (distance)15 μm39 μm78 μm Secondary focus (near addition)47 μm19 μm38 μm 3 Diopters of addition LS-312 MF30 Main Focus (distance)15 μm39 μm78 μm Secondary focus (near addition)99 μm62 μm17 μm

Clinical results Preoperative 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 MF15 Better visual acuity for defocus levels of +1.50, +2.0 and +2.5 D (Mann-Whitney test, p  0.04). Lentis Mplus LS-312 MF30 Better visual acuity for defocus level of 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 PhD Ana Belén Plaza MSc Jorge Alió, MD,PhD