Trifocal IOLs. Clinical Evaluation. Alaa Eldanasoury, MD Magrabi Hospitals & Centers

Transcription

1 Trifocal IOLs Clinical Evaluation Alaa Eldanasoury, MD Magrabi Hospitals & Centers

2 Samos, 1996

3 Athens, 2007

4 Athens, 2009

5 Athens, 2013

6 Athens, 2018

7 Trifocal IOLs Clinical Evaluation Alaa Eldanasoury, MD Magrabi Hospitals & Centers

8 Financial Disclosures Consultant to: Nidek Staar Surgical PhysIOL

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11 At least in my practice Bifocal IOLs were never the standard of care Issues: 1. Poor Intermediate vision. 2. Photic Phenomena. Consequences: 1. Long chair time. 2. Relatively high rate of unsatisfied patients.

12 Multifocal IOLs Bifocals Trifocals EDOF ReStor (Alcon) Tecnis (AMO) Fine Vision (PhysIOL) AT Lisa (Zeiss) PanOptix (Alcon) Symfony (AMO)

13 Fine Vision AT LISA PanOptix Symfony Manufacturer PhysIOL Zeiss Alcon Abbott Concept Trifocal Trifocal Trifocal EDOF Material Hydrophilic/ Hydrophobic Hydrophilic/ hydrophobic surface properties Hydrophobic Hydrophobic Haptic Design Double C loop Plate Haptic C loop C loop Optic Diameter 6.00 mm 6.00 mm 6.00 mm 6.00 mm Diffractive zone 6.00 mm 4.34 mm 4.5 mm - Apodization Yes Non apodized Non apodized Non apodized Asphericity µm µm µm µm

14 Fine Vision AT LISA PanOptix Symfony Available power +6.0 to D 0.00 to D +6.0 to D +5.0 to D Near Add (IOL plane) 3.50 D (40 cm) 3.33 D (40 cm) 3.25 D (40 cm) - Int Add (IOL plane) 1.75 D (80 cm) 1.66 D (80 cm) 2.17 D (60 cm) 1.75 D* Total energy loss 14% 14% 12% - Toric design POD FT 939MP Panoptix Toric ZXT Cylinder (IOL plane) 1.00 to 6.00 D 1.00 to D 1.5 to 6.00 D 1.00 to 3.75 D

15 PODF (PhysIOL)

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19 Clinical Evaluation of Trifocal IOLs Interim Results Prospective Study on consecutive patients. 32 patients (64 eyes) 24 patients (48 Eyes) completed the 3 months exam. Inclusion criteria: Bilateral cataract. No ocular co-morbidity. Phacoemulsification with trifocal POD-F / PODFT (PhysIOL) Both eyes treated during the same week Excluded: Patients with high corneal irregularities. Significant dry eyes. Macular pathology. Glaucoma.

20 Clinical Evaluation of Trifocal IOLs: I. Visual Acuity: FINe Uncorrected. Distance corrected. II. Range of pseudoaccommodation: Defocus curve III. Quality of vision: Scatter (OSI, HD Analyzer). Modulation transfer function (cut off ratio). Contract Sensitivity (HACSS, CTS). IV. Patients satisfaction: Subjective questionnaire.

21 I- Evaluation of Visual Acuity Visual acuity testing Clinical Trial Suite (CTS): Eliminate technician bias Sloan letters Randomized Configured for intermediate and near vision testing Generates automated defocus curves

22 I- Evaluation of Visual Acuity Glare Conditions

23 III- Evaluation of Visual Acuity Near (40 cm) & Intermediate Vision (80 cm)

24 Percent of Total Eyes I- Evaluation of Visual Acuity Refractive Outcome at 3 months 48 Eyes 24 patients Refractive outcome - Percentage within Attempted 100% 100% 100% 83% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% MRSE at 3 months

25 Percent of Total Eyes I- Evaluation of Visual Acuity Cumulative UDVA at 3 month (monocular) 48 Eyes of 24 patients Cumulative UDVA 100% 91% 100% 100% 80% 73% 60% 40% 20% 0% 0% 18% 0% UDVA at 3 months

26 Percent of Total Eyes I- Evaluation of Visual Acuity Monocular DCIVA at 80 cm 48 Eyes of 24 patients Cumulative DCIVA - Percentage 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 25% 25% 75% 100% 100% DCIVA at 80 cm

27 Percent of Total Eyes I- Evaluation of Visual Acuity Monocular DCNVA at 40 cm 50 Eyes of 25 patients Cumulative DCNVA at 40 cm 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 63% 100% 100% DCNVA at 40 cm

28 DCVA (LogMAR) II- Evaluation of Range of pseudoaccommodation Defocus Curve <30 YO Monofocal 0.70 Bifocal 0.80 Trifocal Distance Vision Intermediate Vision Near Vision cm 40 cm Defocus (Variable Distance Simulation)

29 DCVA (LogMAR) II- Evaluation of Range of pseudoaccommodation Defocus Curve Trifocal Binocular (3 mo) Trifocal Monocular (1 mo) Distance Vision Intermediate Vision Near Vision cm 40 cm Defocus (Variable Distance Simulation)

30 III- Evaluation of Quality of Vision Clinical Trial Suite Mesopic Contrast Sensitivity with Glare

31 Log Contrast III- Evaluation of Quality of Vision Average Contrast Sensitivity Curve 48 Eyes of 24 3 months 2.50 Mesopic HACSS Trifocal Normal CPD 3 CPD 6 CPD 12 CPD

32 Objective Scatter Measurement

33 Objective Scatter Index

34 PREOP 3 Mo Post PODF

35 PREOP 3 Mo Post PODFT

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37 IV- Evaluation of Patients Satisfaction Subjective Questionnaire at 3 months All patients are very satisfied or satisfied with FINe vision 12.5% patients reported halos at night. 87.5% patients had non-disturbing photic phenomena when asked. No patients were dissatisfied with vision at any distance. No patients is using spectacles at any distance. All patients would have the same lens again.

38 What we learned so far: Trifocal IOLs give satisfactory far, Intermediate and near vision. Well informed patient. Night vision phenomena remain but the trade-in is very acceptable. Essentials for proper clinical evaluation: Distance corrected Near and Intermediate vision charts / CTS. Defocus curve. Scatter measurement (OSI). Contrast Sensitivity. Tear film assessment.

39 Acknowledgment Cornea & Refractive Surgery Team Magrabi Main Hospital Alaa Eldanasoury, MD Sherif Tolees, MD Ahmed Zaid, MD Carlos Arana, OD Ahmed Qassem, OD Christina Arana, OD Tamer Mabrouk, MBA Marj Aldeguer, RN Mabelle Boco, RN Irish Yabanez, RN Sophia Sorbito, RN Ms. Marwa Abu Elsaoud. Ms. Arwa Bajamal.

40 Thank You!

41 Best candidates for Trifocals Patients with OSI above 1.0 Normal tear film. Hyperopes.

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43 Missing CTS photos

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45 Distance beach Intermediate laptop Near iphone

46 DIFFRACTIVE STEPS The IOL curvature determines the power for distant vision

47 I - Surgical Reversal of Presbyopia 1- Silicone Expansion Plug Implant SEP

48 Surgical Reversal of Presbyopia Scleral Spacing Procedure SSP

49 Pseudo-accommodation Corneal Inlays

50 Pseudo-accommodation Accommodative IOL

51 Pseudo-accommodation Vivarte Presbyopic lens Distant Near Distant Courtesy, Prof G. Baikoff

52 Multifocal Cornea Central Myopic Island Courtsey, A. Telandro

53 Kamra

54 DIFFRACTIVE STEPS The diffractive grating is providing the addition For each step, the light focuses at two foci + some lost light energy

55 DIFFRACTIVE STEPS The added power is a function of the step width: The wider the steps, the smaller the addition. The narrower the steps, the higher the addition.

56 DIFFRACTIVE STEPS Energy Distribution is a function of the step height: The lower the steps, the higher the quantity of energy for far vision The higher the steps, the higher the quantity of energy for near vision

57 Objective Scatter Index

58 Average Defocus Curve at 1 month Distance 1 m 66 cm 40 cm 30 cm

59 Objective Evaluation of Accommodation Range

60 Subjective Questionnaire at 3 months How satisfied are you with the far vision? How satisfied are you with near vision? How satisfaction are you with Intermediate vision? Do you experience difficulty at night?

61 COMBINATION OF TWO DIFFRACTIVE STRUCTURES 1 st diffractive structure 2 nd diffractive structure Order 0 FAR VISION Order D Near vision D Intermediate vision Order D Lost light D Near vision Energy gain allowing a significant improvement in intermediate vision while maintaining far and near vision

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63 Intermediate Vision

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65 Clinical Outcomes 12 Eyes of 6 patients All had bilateral trifocal POD F IOL (PhysIOL) Both eyes treated within 1 week All had excellent visual potential

66 DIFFRACTIVE STEPS Decreasing step height from the center to the periphery = variable repartition of the energy between far and near vision with respect to the pupil diameter

67 Criteria of an ideal Multifocal Covers the full range of vision No photic phenomena

68 Defocus Curve eye1 eye2 eye3 eye

69 Available Trifocal IOLs Diffractive Apodized Hydrophilic Diffractive Non-apodized Hydophilic with Hydrophobic coat Diffractive Non-apodized Hydrophobic

70 DCVA (LogMAR) Evaluation of accommodative potential Defocus Curve <30 YO 0.6 Monofocal Monofocal Distance Vision Intermediate Vision Near Vision Bifocal Trifocal 1.2 Defocus (Variable Distance Simulation)

71 DCVA (LogMAR) Evaluation of clinical outcomes of Trifocals 2- Defocus Curve (Pseudo-accommodative potential) <30 YO 0.6 Monofocal 0.8 Bifocal 1 Distance Vision >6 m Intermediate Vision 80 cm 60 cm 40 cm Near Vision 1.2 Defocus (Variable Distance Simulation)

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