Pseudo-accommodative Cornea (PAC) for the Correction of Presbyopia

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Lionel Wilkins
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1 Pseudo-accommodative Cornea (PAC) for the Correction of Presbyopia Alaa El Danasoury, FRCS Magrabi Hospitals & Centers

2 Surgical options for the Correction of Presbyopia Monovision Reversal of Presbyopia: Anterior Ciliary Sclerotomy Anterior Ciliary Sclerotomy with silicone plugs Scleral expansion segments Laser Presbyopia Reversal (LAPR) Pseudoaccommodation: Intracorneal Lenses AC phakic IOL (Baikoff) Clear lens exchange with Multifocal / Accommodative IOL Pseudoaccommodative LASIK

expansion segments Laser Presbyopia Reversal (LAPR) Pseudoaccommodation: Intracorneal

3 I - Surgical Reversal of Presbyopia 1- Silicone Expansion Plug Implant Regression is common. Possible extrusion. FB sensation. Time consuming. SEP

4 I - Surgical Reversal of Presbyopia 2 - Scleral Spacing Procedure SSP Controversial Time consuming Long term results?

5 II- Pseudo-accommodation 1- Intracorneal lenses Decentration Flap Haze

6 II Pseudo-accommodation 2- CLE with Accommodative IOL

7 II Pseudo-accommodation 3- Vivarte Presbyopic lens Distant Near Distant

8 II - Pseudo-accommodation 4- LASIK Multifocal Cornea o Central Myopic Island o Paracentral Myopic Ring o Decentered Myopic Island o Controlled Multizone Aspheric LASIK

9 Multifocal Cornea Decentered Myopic Island Central Myopic Island Courtsey, A. Telandro

11 Multifocal Cornea Concerns Safety: Loss of Distant BSCVA Loss of Contrast Sensitivity Stability 6 & 12 Months data Efficacy: Near vision with distant correction Patient satisfaction Subjective questionnaire:

Months data Efficacy: Near vision with distant

12 Evaluation of Pseudo- Accommodative LASIK Study I: (MZ vs Conv LASIK) Assess safety Randomized Bilateral Comparative study Multizone vs Conventional LASIK Study II: (MZ LASIK for presbyopia) Assess the efficacy, predictability & stability for near vision Bilateral non-randomized non-comparative study

Conventional LASIK Study II: (MZ LASIK for presbyopia) Assess the efficacy,

13 Multizone vs Conventional LASIK Inclusion Criteria Age: 21 to 36 yrs Baseline SE: to 9.00 D Stable Refraction SCVA: 20/20 or better. Mesopic pupil diameter: < 7 mm.

$00 D Stable Refraction SCVA: 20/20 or$

14 Multizone vs Conventional LASIK Demographics 30 consecutive patients 60% females Mean age: 29 ± 5.4 yrs (21 to 37 yrs) Mean baseline SE: Multizone Group: ± 1.9 D (-1.64 to 8.64 D) Conventional Group: ± 1.9 D (-1.75 to 8.00 D) 22 patients completed 6 months follow up.

4 yrs (21 to 37 yrs) Mean baseline SE: Multizone Group: -4.28 ± 1.

15 Predictability 22 patients, 1 Month Multizone Conventional

16 Predictability 22 patients, 6 Months (Enhancements included) Multizone Conventional

17 Enhancement Rate Multizone: 40.9% (9 / 22) Conventional: 4.5% (1 /22)

18 UCVA at 6 Months (Enhancements Included) /20 or better 20/30 or better 20/40 or better MZ Conv

19 Loss & Gain of SCVA 22 patients, 6 Months MZ Conv

20 Contrast-Sensitivity Average Curve Multizone Conventional

21 Contrast-Sensitivity with Glare Average Curve Multizone Conventional

22 Conclusion Mutizone Aspheric LASIK is: As effective as conventional LASIK for distant correction Does not compromise CS Does not increase night glare Conventional nomogram needs adjustment

23 Pseudo-Accommodative Cornea (PAC) for the Correction of Presbyopia Alaa El Danasoury, FRCS Magrabi Hospitals & Centers

24 Aim of the Study Assess efficacy, predictability, stability & safety of Multizone Aspheric LASIK to create Pseudo-Accommodative Cornea (PAC) for correction of presbyopia

25 Study Design Prospective Bilateral Non-comparative, Non-randomized Consecutive patients Single Center

26 Inclusion Criteria Presbyopia. Candidate for Bilateral LASIK. Manifest Refraction (-6.0 to +4.0 D) Refractive Cylinder: 2.00 D or less. Distant SCVA: 20/25 or better. Near Add: 1.0 D or more. Near SCVA: J1 or better.

27 Demographics Hyperopic Group 54 eyes of 27 patients % were males. Mean age: 50 ± 4.9 yrs. Range: 40 to 62 yrs. Follow up rate: 1 month: 46 eyes (85.2%) 3 months: 38 eyes (70.4%) 6 months: 16 eyes (29.6%) 12 months: 8 eyes (14.8%) Myopic Group 50 eyes of 25 patients. 68% were males. Mean age: 46.0 ± 4.3 yrs. Range: 40 to 56 yrs. Follow up rate: 1 month: 40 eyes (80%) 3 months: 46 eyes 92%) 6 months: 34 eyes (68%) 12 months: 8 eyes (16%)

28 Age Distribution 100% month (eyes) 90% 80% 70% 60% 50% 48% 72% Hyp (54) Myo (50) 40% 30% 37% 28% 20% 10% 0% 15% Y Age Distribution - Percent Datagraph

29 Presbyopia Patient Groups Primary hyperopic presbyopes hyperopia plus presbyopia treatment Primary myopic presbyopes treated for myopia and presbyopia

30 Methods Step 1: Correction of myopic error 2 or 3 concentric zones at 4,5,6 mm with 2 mm TZ Step 2: Correction of presbyopia ± hyperopia Large hyperopic ablation zone at 7.0 / 9.5 mm. Step 3: Reversal of the induced myopia Two central 3.5 and 4.0 mm with 1 mm TZ.

31 NIDEK PAC Calculator

32 Baseline Refraction Hyperopic Group: SE Refraction: 1.87 ± 0.91 D (0.38 to 4.00 D) Near Add: 1.94 ± 0.2 D (1.75 to 2.25 D) Myopic Group: SE Refraction: ± 1.51 D (-5.75 to 0.25 D) Near Add: 1.67 ± 0.44 D (1.00 to 2.50 D)

33 Predictability - Hyperopia Group Enhancement Rate: 5.6% (1/18 eyes) Achieved [D] eyes overcorrected 6 months ±0.5 D: 15 eyes (83.3%) ±1.0 D: 17 eyes (94.4%) ±1.5 D: 18 eyes (100%) 1.5 y = -0.00x x undercorrected Datagraph Attempted delta SR equiv. [D]

34 Predictability Myopia Group Enhancement Rate: 35.3% (12/34 eyes) Achieved [D] 34 Eyes at 6 Mos overcorrected y = 0.01x x ±0.5 D: 24 eyes (70.5%) ±1.0 D: 33 eyes (97.1%) Datagraph undercorrected Attempted delta SR equiv. [D]

35 Stability Hyperopic Group pre op 1 w 1 m 3 m 6 m Datagraph STABILITY: Achieved Change in Refr. over Time

36 0,50 0,00 Stability Myopic Group -0,39-0,70-0,73-0,57 pre op -0,50 1 w 1 m 3 m 6 m -1,00-1,50-2,00-2,50-2,87-3,00-3,50-4,00-4,50-5, STABILITY: Achieved Change in Refr. over Time Datagraph

37 Distant UCVA Hyperopic Group 100% 90% 80% 70% 60% 58% 85% 81% 90% 92% 90% month (eyes) 3 m (36) 6 m (20) 50% 40% 40% 30% 25% 20% 10% 0% 20/12 or better 3% 5% 20/15 or better 20/20 or better 20/25 or better 20/30 or better Cumulative UCVA - Percent 20/40 or better 8% 10% 20/50 or worse Datagraph

38 Distant UCVA Myopic Group 100% 97% month (eyes) 90% 85% 88% 85% 80% 70% 60% 59% 68% 3 m (46) 6 m (34) 50% 40% 30% 20% 10% 0% 20/12 or better 9% 2% 20/15 or better 22% 26% 20/20 or better 20/25 or better 20/30 or better Cumulative UCVA - Percent 20/40 or better 15% 3% 20/50 or worse Datagraph

39 Safety Hyperopic Group 100% month (eyes) 90% 80% 70% 3 (36) 6 (16) 60% 50% 40% 30% 20% 44% 31% 39% 56% 10% 0% 8% 6% 6%6% 3% lost > 2 lost 2 lost 1 unchanged gained 1 gained 2 gained > 2 2. SAFETY: Change in BSCVA - Percent Datagraph

40 Safety Myopic Group 100% month (eyes) 90% 80% 70% 60% 50% 40% 70% 62% 3 (46) 6 (34) 30% 20% 10% 13% 24% 17% 15% 0% lost > 2 lost 2 lost 1 unchanged gained 1 gained 2 gained > 2 2. SAFETY: Change in BSCVA - Percent Datagraph

41 Contrast Sensitivity Hyperopic Group

42 Contrast Sensitivity 2.20 Myopic Group month pre op (42) 1 m (36) 3 m (26) 6 m (24) A (3cpd) B (6cpd) C (12cpd) D (18cpd) Spatial Frequency [cycles/degree] Datagraph

43 CS with glare Hyperopic Group month pre op (42) 1 m (26) 3 m (12) 6 m (14) A (3cpd) B (6cpd) C (12cpd) D (18cpd) Spatial Frequency [cycles/degree] Datagraph

44 CS with glare Myopic Group month pre op (42) 1 m (36) 3 m (26) 6 m (23) A (3cpd) B (6cpd) C (12cpd) D (18cpd) Spatial Frequency [cycles/degree] Datagraph

45 Near Visual Acuity Without Correction With Distant Correction With Near Correction

46 Near UCVA Hyperopic Group 100% 90% 80% 81% 94% 100% 92% 88% month (eyes) pre op (50) 70% 60% 50% 40% 30% 33% 44% 56% 50% 67% 63% 3 m (36) 6 m (16) 20% 10% 0% 12% 8% 4% J1+ or better J1 or better J2 or better J3 or better J5 or better J7 or worse Cumulative near UCVA - Percent Datagraph

47 Near UCVA Myopic Group 100% 90% 80% 70% 60% 50% 47% 63%62% 93% 91% 93%94% 83% 84% 74% 74% 53% month (eyes) pre op (43) 3 m (46) 6 m (34) 40% 30% 28% 33% 21% 20% 10% 0% 16% 7%6% J1+ or better J1 or better J2 or better J3 or better J5 or better J7 or worse Cumulative near UCVA - Percent Datagraph

48 Near UCVA with Distant Correction Hyperopic Group 100% 90% 80% 70% 60% 50% 40% 30% 20% 22% 31% 36% 44% 50% 69% 38% 81% 94% 62% 100% 94% 38% month (eyes) pre op (50) 3 m (36) 6 m (16) 10% 4% 6% 6% 6% 0% J1+ or better J1 or better J2 or better J3 or better J5 or better J7 or worse Cumulative near UCVA with far correction - Percent J3 or better: BL 38%, 3 Mos: 81%, 6 Mos: 94% Datagraph

49 Near UCVA with Distant Correction Myopic Group 100% 90% 80% 70% 60% 50% 40% 41% 41% 39% 55% 59% 50% 73% 76% 84% 93% 91% month (eyes) pre op (44) 3 m (44) 6 m (34) 30% 20% 10% 18%18% 20% 16% 7% 9% 0% J1+ or better J1 or better J2 or better J3 or better J5 or better J7 or worse Cumulative near UCVA with far correction - Percent Datagraph J3 or better: BL; 50%, 3 Mos: 73%, 6 Mos;76%

50 Near VA with Distant Correction Myopic Group Percent of Total Eyes L -1 L No Change L or more L or more L or more L or more Loss & gain of Distant Corrected Near VA

51 Change in Near BSCVA Hyperopic Group 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 94% 78% 19% 3% 6% lost > 2 lost 2 lost 1 unchanged gained 1 gained 2 gained > 2 Change in near BSCVA - Percent month (eyes) 3 (32) 6 (16) Datagraph

52 Change in Near BSCVA Myopic Group 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 5% 13% 93% 88% lost > 2 lost 2 lost 1 unchanged gained 1 gained 2 gained > 2 3% Change in near BSCVA - Percent month (eyes) 3 (40) 6 (32) Datagraph

53 HO RMS 1&6 Month after Surgery HO RMS [µm] 0,90 0,80 0,70 0,60 0,50 0,40 0,30 Myo Group Hyp Group 0,56 0,46 0,57 0,81 0,56 0,78 0,20 0,10 0,00 pre OP 1 month 6 month

54 Strehl Ratio 1&6 Month after Surgery 0,12 0,10 0,10 Myo Group Hyp Group Strehl Ratio 0,08 0,06 0,04 0,07 0,07 0,04 0,05 0,03 0,02 0,00 pre OP 1 month 6 month

55 Q-Value (Asphericity) 1&6 Month after Surgery 0,40 0,20 0,21 0,08 0,29 0,19 unchanged Q Value 0,00-0,20 pre OP 1 month 6 month -0,40-0,60-0,80 Myo Group Hyp Group -0,39 beocmes more prolate! -0,69

56 Hyperopic

58 Myopia

60 Patient Questionnaire Are you using Spectacles for reading your newspapers? Hyperopes (9 patients) Never: 7 (77.8%) Occasionally: 1 (11.1%) Always: 1 (11.1%) Myopes (17 patients) 13 (76.5%) 3 (17.6%) 1(5.9%)

61 Conclusion Multizone Multifocal LASIK: Effective in correction of far & near vision. Does not affect the quality of distant vision. Nomograms need refinement Larger series and longer follow up is needed.

62 Questions to Answer The theoretical 'peripheral near zone' model needs to be refined only the myopia/presbyopia group shows a peripheral near zone on OPD maps postop most of the hyp/presbyopia cases have a central near zone on OPD maps Long term stability Effect of pupil size on near vision Best ablation profile to minimize spherical aberrations

63 Thank you for your attention!

Quality Control in Refractive Surgery

$Quality Control in Refractive Surgery$ Quality Control in Refractive Surgery Stefan Pieger*, M.Sc. Ingenieurbüro Pieger GmbH, Wendelstein, Germany Introduction Personal experience as application specialist for refractive excimer lasers since