Guy%20Kleinmann,%20MD1

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Biocompatibility of a New Hydrophobic Acrylic
Material for Fabrication of IOLs
Guy Kleinmann, MD1 Shmuel Ben-Elihau, DVM2

1. Ophthalmology Department, Kaplan Medical Center
2. Harlan Biotech Israel

Guy Kleinmann is a consultant for Hanita Lenses
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Purpose
To evaluate the biocompatibility of a new
hydrophobic IOL material the Benz-HF1 Natural
Yellow, Using the SeeLens IOL (Hanita, Israel)
as a platform
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Methods

• 10 NZW rabbits
• Each rabbit was randomly implanted with the
• new hydrophobic IOL in one eye and B-lens
• IOL (Hanita, Israel) in the fellow eye
• Follow up 1D, 1W, 1M, 3M, 6M
• Each follow up included
• Photography
• Slit lamp clinical evaluation

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Methods cont.

• At the end of the study
• Enucliation of the eye
• Explantion of the lens
• Histological evaluation of the eye
• SEM/EDS of the explanted IOLs

• Analysis of the explanted IOLs

• Light microscopy analysis (all IOLs)
• Transmission spectrum (half of the IOLs)
• Scanning electron microscopic energy
• dispersive x-ray (SEM/EDX) (half of the IOLs)
• Two non-implanted IOLs of each IOL
• served as negative controls

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Results Macroscopic 1 month
New Hydrophobic
Control
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ResultsSlit lamp evaluation
1 month
3 months
6 months
Control
New Hydrophobic
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Results
6 months slit lamp evaluation
Test Control
Decentration 1/10 2/10
Tilt 0/10 1/10
Pigments on the surface of the IOL 2/10 5/10
Soemmerings ring 10/10 10/10
PCO 10/10 10/10
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Histopathological results

FINDING B-Lens (Control Product) Hydrophobic IOL (Test Product)
FINDING Control Eye Test Eye
FINDING n10 n10
No lesion (1/10) (0/10)
Cornea periphery mixed mononuclear cell infiltration, multifocal 0.9 (9/10) 1.0 (10/10)
Lens Presence of regenerating cortical material 1.0 (5/10) 1.4 (7/10)
Iris - mixed mononuclear cell infiltration, multifocal 0.2 (2/10) 0.1 (1/10)
Cornea hair granuloma, multifocal 0.1 (1/10) 0.0 (0/10)
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Histology summary

• No treatment related nor material
• related changes were noted
• All reported changes had
• comparable incidence in both groups

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SEM/EDS of explanted IOLs
Control
New Hydrophobic
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Explanted IOLs- summary
The Investigated hydrophobic study IOLs were
superior in comparison to the control lenses
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Discussion

• The Benz-HF1 Natural Yellow material was found to
  be superior to the hydrophilic IOL in all the IOL
  analysis parameter
• No difference between the groups was found in the
  clinical and histological evaluations

Conclusion
The Benz-HF1 Natural Yellow material, using the
SeeLens IOL platform (Hanita, Isreal),
demonstrated excellent biocompatibility in the
Rabbit model of ocular implantation test