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Financial disclosure: The study was supported by a grant from Hanita Lenses, Israel Dr. Kleinmann and Prof. Assia are consultants for Hanita Lenses, Israel Guy Kleinmann 1 , Roy Alon 2 ,Ehud I. Assia 2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel
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Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Jul 29, 2020

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Page 1: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Financial disclosure: The study was supported by a grant from Hanita Lenses, Israel

Dr. Kleinmann and Prof. Assia are consultants for Hanita Lenses, Israel

Guy Kleinmann1, Roy Alon2,Ehud I. Assia2

[1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Page 2: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

PCO is still a problem, mainly with premium IOLs

Last year we presented our preliminary favorable PCO prevention results while using the Open Capsule Device

Page 3: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

To investigate the ability of the PID to prevent PCO using hydrophilic and hydrophobic materials and IOLs

Page 4: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Dimensions for rabbit trial:

Total Diameter: 11 mm

Device height: 1.5 mm

Hydrophilic and

hydrophobic rings *patent pending

Page 5: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Both IOLs:

Total Diameter: 13 mm

Optic diameter: 6 mm

3600 square edge

Tecnis (AMO)

Hydrophobic IOL

SeeLens AF (Hanita Lenses)

Hydrophilic IOL

Page 6: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

36 NZW rabbit eyes were divided into six groups and implanted, after lens removal, as following:

Following tests were performed: Slit Lamp and Miyake Apple evaluation at 6 weeks

Histopathological evaluation

Hydrophobic IOL (Tecnis, AMO)

Hydrophilic IOL (SeeLens, Hanita Lenses)

6 eyes 6 eyes Control (IOL only)

6 eyes 6 eyes Hydrophilic ring (Hanita Lenses)

6 eyes 6 eyes Hydrophobic ring (Hanita Lenses)

Page 7: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Implantation of hydrophilic ring was easier, and can be compared to standard IOL implantation

Insertion of IOL haptics into the PID groove was not automatic and required manipulations

Ovalization due to large

diameter of the ring

The capsule remained open

Page 8: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Control Ring

75% less PCO compared to control

Hydrophobic IOL Hydrophilic IOL

3.1 ± 1.2 2.7 ± 1.1 Control (IOL only)

1.1 ± 0.9 0.6 ± 0.6 Hydrophilic ring**

0.6 ± 0.9 0.7 ± 0.7 Hydrophobic ring**

PCO score*:

(severe)4 (absent) to 0 [*] **P-value<0.05

Page 9: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Control Ring

Significant reduction in Soemmering’s ring development in test groups

Page 10: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Region of Soemmering’s ring coverage was manually marked and analyzed using Matlab software

Soemmering’s ring

Region of interest (bag excluding optical zone)

Page 11: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

80% less Soemmering’s ring coverage compared to control

Hydrophobic IOL Hydrophilic IOL

52 ± 8 mm2 (95%) 52 ± 10 mm2 (92%) Control (IOL only)

13.6 ± 7 mm2 (22%) 9.6 ± 6 mm2 (17%) Hydrophilic ring

11 ± 11 mm2 (15%) 14.6 ± 9 mm2 (22%) Hydrophobic ring

Soemmering’s ring coverage *:

% (full coverage)100% (clear capsule) to 0[*]

Control Ring

Page 12: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Control group:

Page 13: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Control group:

Page 14: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Test group:

Page 15: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Test group:

Page 16: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Test group:

Page 17: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Test group: atypical observation

Page 18: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Hydrophobic IOL Hydrophilic IOL Histological PCO grading

2.8 2.2 Control (IOL only)

0.7 (75%↓) 1.3 (35%↓) Hydrophilic ring

0.6 (79%↓) 0.6 (73%↓) Hydrophobic ring

*Grade 0 - no LEC proliferation, grade 4 – above 10 layers of LEC proliferation

Page 19: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Encouraging PCO prevention results for both ring materials

No significant difference between hydrophilic and hydrophobic IOLs

Our results suggested primary PCO prevention

Mechanism not completely clear: Open capsule?

Windows in the PID design – prevention of ischemia?

Page 20: Guy Kleinmann , Roy Alon2,Ehud I. Assia · Guy Kleinmann1, Roy Alon2,Ehud I. Assia2 [1] Kaplan Medical Center, Rehovot, Israel [2] Meir Medical Center, Kfar-Saba, Israel

Thank you!