Comparison of the visual outcomes of abifocal refractive versus atrifocal diffractive IOL

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$Comparison of the visual outcomes of abifocal refractive versus atrifocal diffractive IOL Jérôme C. VRYGHEM, M.$

1 Comparison of the visual outcomes of abifocal refractive versus atrifocal diffractive IOL Jérôme C. VRYGHEM, M.D. Steven HEIREMAN, M.D. Clinique St-Jean, Brussels Brussels Eye Doctors, Brussels Belgium No financial interest!

2 My experience Multifocal and accomodative IOL s AMO Array 1997 Ioltech MF4 Crystalens AT-45 Humanoptics 1CU Acri.Twin Acri.Lisa

3 TwonewmultifocalIOL s Oculentis M Plus Bifocal Refractive Physiol FineVision Trifocal diffractive N=100 eyes N=250 eyes

4 OCULENTIS Mplus A new concept of multifocal IOL technology: 6 months results Jérôme C. VRYGHEM, M.D. Steven HEIREMAN, M.D. Clinique St-Jean, Brussels Brussels Eye Doctors, Brussels Belgium No financial interest!

$with refractive design Aspheric,$ asymmetric distance-vision zone

5 Oculentis Mplus One-piece multifocal IOL with refractive design Aspheric, asymmetric distance-vision zone Sector-shaped near-vision zone of D Seamless transition zone

6 Oculentis Mplus

7 Oculentis Mplus Acrylic material 360 continuous square optic and haptic edge Independent of pupil size Reflection of light hitting the transition area away from the optical axis To prevent superposition of interference or diffraction Minor loss of light intensity Improved contrast sensitivity Reduced glare and halo effects

8 Oculentis Mplus IOL calculation IOL-Masterin all eyes A-constant: IOL-positioning Marks onthe opticof the IOL IOL to berotatedin verticalpositionwithreading segment positioned inferiorly MICS

9 Clinical Study Settings Oculentis MPlus Retrospective study (Clinique St-Jean Brussels and Brussels Eye Doctors) 25 patients (24 binocular and 1 monocular), 49 eyes Mean age: 72 years (39-87 years) Follow-up 6 months

10 Clinical Study Selection of patients Oculentis MPlus Cataract and RLE patients No other pathology Pre-op astigmatism 1 D Uneventful surgery No surgically induced astigmatism: MICS with temporal incision of 1.9 mm

11 Clinical Study Methods Oculentis MPlus UCDVA and BCDVA UCNVA Refraction Defocus curve Questionnaire to evaluate: Independence towards reading glasses Patient satisfaction

12 Clinical Study Results: VA Mean UCDVA: 0.88 ±0.24 ( ) Oculentis MPlus N=49

13 Clinical Study Results: VA Mean BCDVA: 1.02 ±0.22 ( ) Oculentis MPlus N=49

14 Clinical Study Results: VA Oculentis MPlus N=49 Mean UCNVA: Parinaud 3.75 (Parinaud 7 Parinaud 1.4)

$Clinical Study Results: Refraction Average spherical equivalent: 0.02 ± 0.$

15 Clinical Study Results: Refraction Average spherical equivalent: 0.02 ± 0.24 D Oculentis MPlus N=49 IOL repositioning: 4 % (1 patient) Secondary refractive retreatment: 4% (1 patient)

16 Clinical Study Results: Defocus Curve Oculentis MPlus N=49 0,4 at intermediate distance

17 Clinical Study Results: Questionnaire Oculentis MPlus Would you undergo implantation with this lens type again? Yes: 88 % (22 patients) No: 4 % (1 patient) Undecided: 8 % (2 patients) Use of near spectacles: No: 52 % (13 patients) Yes: Only for small characters: 12 % (3 patients) Always: 36 % (9 patients)

18 Clinical Study Results: Questionnaire Oculentis MPlus Use of distance spectacles: none Ghost images: 4 % (1 patient) Double images: none

19 Clinical Study Results: Questionnaire Oculentis MPlus Halos Spontaneously: 8 % (2 patients) On inquiry: 20 % (5 patients) Glare Spontaneously: 4 % (1 patient) On inquiry: 12 % (3 patients) Discoloration Spontaneously: 4 % (1 patient) On inquiry: 12 % (3 patients)

20 Clinical Study Results: Questionnaire Oculentis MPlus Subjective quality of vision Good Average Poor Watching TV 92 % 8 % 0 % (23 patients) Reading a book 76 % (19 patients) Needlework 80 % (20 patients) (2 patients) 16 % (4 patients) 20 % (5 patients) 8 % (2 patients) 0 %

21 Oculentis MPlus Conclusion Good distant and intermediate VA Average near VA Halos spontaneously reported in 8% of patients High patient satisfaction J. C. Vryghem, S. Heireman

22 Early results with the implantation of the Physiol FineVision : a new trifocal diffractive IOL Jérôme C. VRYGHEM, M.D. Steven HEIREMAN, M.D. Clinique St-Jean, Brussels Brussels Eye Doctors, Brussels Belgium No financial interest!

Overall 10.75 mm Opticbody 6.15 mm Angulation: 5 A-constant: 118.

23 PhysiolFineVision Same platform as Physiol Micro AY Material: Hydrophilic Acrylate with 25 % water content Yellow: UV and blue light blocker Dimensions: Overall mm Opticbody 6.15 mm Angulation: 5 A-constant: (IOL-Master), (US) Optic is biconvex and aspheric Power range: to D in 0.50 D steps

$PhysiolFineVision Trifocal diffractive (over$ combination of 2 bifocal patterns (+1.

24 PhysiolFineVision Trifocal diffractive (over the whole optic) IOL achieved by the combination of 2 bifocal patterns (+1.75 D add and D add) F ar I ntermediate Vision NE ar

25 PhysiolFineVision Bifocal diffractive lens Trifocal diffractive lens

26 PhysiolFineVision Combination of two diffractive patterns First diffractive grating Second diffractive grating Order 0 Far vision Far vision Order D Near vision 1.75 D Intermediate vision Order2 Lostlight (+ 7 D) D Nearvision The second order of the +1.75D add diffractive grating is reinforcing the first order of the +3.5D add diffractive grating, providing an improvement in intermediate vision in maintaining far and near vision

27 PhysiolFineVision This IOL is apodized: the step height decreases from the center towards the periphery. This diffractive pattern is then pupil dependent allocating more energy to far vision in dim conditions (large pupil).

28 PhysiolFineVision Far % Energy Near 10 0 Intermediate 1,50 2,00 2,50 3,00 3,50 4,00 4,50 5,00 Pupil diameter (mm)

29 Clinical Study Settings Physiol FineVision Prospective observational study (Clinique St-Jean Brussels and Brussels Eye Doctors) 32 eyes, 16 patients(binocular) Meanage: 75 ±10 years(65-84 years) Mean preoperative best corrected visual acuity 0.59 ±0.15

30 Physiol FineVision Settings: Patient selection Cataract and RLE patients No other pathology Pre-op astigmatism 1 D Uneventful surgery by the same surgeon (JCV)

31 Physiol FineVision Settings: Surgical parameters IOL calculation IOL-Masterin all eyes A-constant: 118.5!!! IOL-positioning: autocentering MICS withtemporal incisionof 1.9 mm: No surgically induced astigmatism

32 Methods Physiol FineVision 2 months post-op: Distance VA Near and intermediate VA Mesopic VA Refraction Defocus curve Questionnaire to evaluate: Independence towards reading glasses Patient satisfaction

33 Physiol FineVision Results Postoperative refraction Percentag ge of eyes Mean spherical equivalent = 0.03 ±0.3 D 100% -0.5 and +0.5 D -1-0,5 0 0,5 1 Achieved postoperative spherical equivalent (D)

34 Results: Distance Uncorrected VA Physiol FineVision Mean monocular UCVA 0.90 ± % % 0.8 (dryness) Mean binocular UCVA 1.13 ± % % 0.8

35 Results: Best Distance Corrected VA Physiol FineVision Mean monocular BDCVA 0.96 ± % % 0.8 Mean binocular BDCVA 1.14 ± % % 0.8

36 Results: Physiol FineVision Uncorrected Intermediate VA Parinaud 2 = Jaeger 1 Mean monocularuciva: Parinaud 2.46 ± ,9% P4 84,3% P3 Mean binocular UCIVA: Parinaud 1.69 ± % P4 100% % P3

37 Results: Uncorrected Near VA Physiol FineVision Mean monocularucnva Parinaud 1.34 ± % P % P2 Mean binocular UCNVA Parinaud 1.08 ± % P3 100% % P2

38 Results: Defocus curve Physiol FineVision Visual acuity (Decimal) 1,4 1,2 1 Defocus add (D) 0,8 0,6 0,4 0, Binocular defocus curve (16 patients)

39 Results: Mesopic VA Physiol FineVision Apodization outcomes: near and intermediate visual acuities drop in mesopic conditions for far vision enhancement. Visual acuity (Par rinaud) Intermediate Near t-test small sample p< Photopic Mesopic

40 Results: Questionnaire Physiol FineVision Would you undergo implantationwiththislens type again? Yes: 76 % 24 % cannot answer because they cannot compare. Good quality of vision 100% 80% 60% 40% 20% 0% 94 % Use of near spectacles Use of distance spectacles

41 Results: Questionnaire Physiol FineVision Use of near spectacles: No: 82 % Yes: Only for small characters: 18 % Always: none Good quality of vision 100% 80% 60% 40% 20% 0% Use of distance spectacles: 6 % Use of near spectacles 18 % Use of distance spectacles 6 %

42 Physiol FineVision Results: Questionnaire No difficulties for light transition No ghost image 100% 80% 60% 40% 20% 0% No double image No discoloration No halos Glare:6% No glare Halos: Spontaneously: 9% On inquiry: 9%

43 Results: Questionnaire Physiol FineVision Subjective quality of vision Good Average Poor Watching TV 100 % none none Reading a book 94 % 6 % none Needlework 94 % 6 % none

44 Physiol FineVision Conclusions Good distance, intermediate and near VA Apodization to favor night vision is effective High(er) patient (and surgeon) satisfaction

$Physiol FineVision trifocal diffractive IOL adds$ intermediate vision with no significant decrease in

45 Physiol FineVision Conclusions The design of the Physiol FineVision trifocal diffractive IOL adds intermediate vision with no significant decrease in near and distance vision as compared to currently available bifocal IOL s

46 Thank you for your attention!

Far. Intermediate. Near. The first trifocal

Far. Intermediate. Near. The first trifocal Far Intermediate Near The first trifocal diffractive IOL FINEVISION : Unique Concept Combination of 2 profiles** Profile n 1 Orders Profile n 2 FAR (eg. + 2 D) Order (determinated by curvature of the IOL)