Pseudo-accommodative Cornea (PAC) for the Correction of Presbyopia Alaa El Danasoury, FRCS Magrabi Hospitals & Centers
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
I - Surgical Reversal of Presbyopia 1- Silicone Expansion Plug Implant Regression is common. Possible extrusion. FB sensation. Time consuming. SEP
I - Surgical Reversal of Presbyopia 2 - Scleral Spacing Procedure SSP Controversial Time consuming Long term results?
II- Pseudo-accommodation 1- Intracorneal lenses Decentration Flap Haze
II Pseudo-accommodation 2- CLE with Accommodative IOL
II Pseudo-accommodation 3- Vivarte Presbyopic lens Distant Near Distant
II - Pseudo-accommodation 4- LASIK Multifocal Cornea o Central Myopic Island o Paracentral Myopic Ring o Decentered Myopic Island o Controlled Multizone Aspheric LASIK
Multifocal Cornea Decentered Myopic Island Central Myopic Island Courtsey, A. Telandro
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:
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
Multizone vs Conventional LASIK Inclusion Criteria Age: 21 to 36 yrs Baseline SE: -1.00 to 9.00 D Stable Refraction SCVA: 20/20 or better. Mesopic pupil diameter: < 7 mm.
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: -4.28 ± 1.9 D (-1.64 to 8.64 D) Conventional Group: -4.20 ± 1.9 D (-1.75 to 8.00 D) 22 patients completed 6 months follow up.
10 9 8 7 6 5 4 3 2 1 0 Predictability 22 patients, 1 Month 0 1 2 3 4 5 6 7 8 9 10 Multizone Conventional
10 9 8 7 6 5 4 3 2 1 0 Predictability 22 patients, 6 Months (Enhancements included) 0 1 2 3 4 5 6 7 8 9 10 Multizone Conventional
Enhancement Rate Multizone: 40.9% (9 / 22) Conventional: 4.5% (1 /22)
UCVA at 6 Months (Enhancements Included) 100 90 80 70 60 50 40 30 20 10 0 20/20 or better 20/30 or better 20/40 or better MZ Conv
Loss & Gain of SCVA 22 patients, 6 Months 100 90 80 70 60 50 40 30 20 10 0 2 1 0-1 -2 MZ Conv
Contrast-Sensitivity Average Curve Multizone Conventional
Contrast-Sensitivity with Glare Average Curve Multizone Conventional
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
Pseudo-Accommodative Cornea (PAC) for the Correction of Presbyopia Alaa El Danasoury, FRCS Magrabi Hospitals & Centers
Aim of the Study Assess efficacy, predictability, stability & safety of Multizone Aspheric LASIK to create Pseudo-Accommodative Cornea (PAC) for correction of presbyopia
Study Design Prospective Bilateral Non-comparative, Non-randomized Consecutive patients Single Center
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.
Demographics Hyperopic Group 54 eyes of 27 patients. 59.3 % 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%)
Age Distribution 100% month (eyes) 90% 80% 70% 60% 50% 48% 72% Hyp (54) Myo (50) 40% 30% 37% 28% 20% 10% 0% 15% 0-9 10-19Y 20-29 30-39 40-49 50-59 60-69 70-79 80-89 90-99 Age Distribution - Percent Datagraph
Presbyopia Patient Groups Primary hyperopic presbyopes hyperopia plus presbyopia treatment Primary myopic presbyopes treated for myopia and presbyopia
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.
NIDEK PAC Calculator
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: -2.87 ± 1.51 D (-5.75 to 0.25 D) Near Add: 1.67 ± 0.44 D (1.00 to 2.50 D)
Predictability - Hyperopia Group Enhancement Rate: 5.6% (1/18 eyes) Achieved [D] 5.0 18 eyes 4.5 4.0 overcorrected 6 months 3.5 3.0 2.5 2.0 ±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 2 + 1.18x - 0.09 1.0 0.5 undercorrected Datagraph 0.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 Attempted delta SR equiv. [D]
Predictability Myopia Group Enhancement Rate: 35.3% (12/34 eyes) Achieved [D] 34 Eyes at 6 Mos 6.0 5.5 5.0 overcorrected 4.5 4.0 3.5 3.0 2.5 2.0 1.5 y = 0.01x 2 + 0.85x - 0.05 ±0.5 D: 24 eyes (70.5%) ±1.0 D: 33 eyes (97.1%) Datagraph 1.0 0.5 undercorrected 0.0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 Attempted delta SR equiv. [D]
Stability Hyperopic Group 3.00 2.50 2.00 1.87 1.50 1.00 0.50 0.00-0.32-0.27-0.61-0.41 pre op 1 w 1 m 3 m 6 m -0.50-1.00-1.50 Datagraph -2.00 54 30 44 36 16 1. STABILITY: Achieved Change in Refr. over Time
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 -1,00-1,50-2,00-2,50-2,87-3,00-3,50-4,00-4,50-5,00 50 28 40 46 34 1. STABILITY: Achieved Change in Refr. over Time Datagraph
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
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
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
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
Contrast Sensitivity Hyperopic Group
Contrast Sensitivity 2.20 Myopic Group 2.00 1.80 1.60 1.40 1.65 1.68 1.69 1.89 1.92 1.91 1.57 1.56 1.60 1.54 month pre op (42) 1 m (36) 3 m (26) 6 m (24) 1.20 1.00 1.18 1.11 1.13 1.08 0.80 0.60 0.40 A (3cpd) B (6cpd) C (12cpd) D (18cpd) Spatial Frequency [cycles/degree] Datagraph
CS with glare Hyperopic Group 2.20 2.00 month 1.80 1.60 1.40 1.54 1.55 1.50 1.77 1.79 1.74 1.72 1.48 1.43 1.42 pre op (42) 1 m (26) 3 m (12) 6 m (14) 1.20 1.00 1.11 1.10 0.99 1.02 0.80 0.60 0.40 A (3cpd) B (6cpd) C (12cpd) D (18cpd) Spatial Frequency [cycles/degree] Datagraph
CS with glare Myopic Group 2.20 2.00 month 1.80 1.60 1.40 1.53 1.50 1.54 1.79 1.74 1.76 1.72 1.48 1.43 1.41 1.44 pre op (42) 1 m (36) 3 m (26) 6 m (23) 1.20 1.00 1.07 1.08 1.01 0.80 0.60 0.40 A (3cpd) B (6cpd) C (12cpd) D (18cpd) Spatial Frequency [cycles/degree] Datagraph
Near Visual Acuity Without Correction With Distant Correction With Near Correction
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
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
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
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%
Near VA with Distant Correction Myopic Group Percent of Total Eyes 60 50 40 30 20 10 0 0 7.1 9.5-2 L -1 L No Change 59.5 + 1 L or more 33.3 + 2 L or more 26.2 + 3 L or more 2.4 + 5L or more Loss & gain of Distant Corrected Near VA
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
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
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
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
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
Hyperopic
Myopia
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%)
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.
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
Thank you for your attention!