Guy Kleinmann, MDGuy Kleinmann, MD11

Shmuel Ben-Elihau, DVMShmuel Ben-Elihau, DVM22

Biocompatibility of a New Biocompatibility of a New Hydrophobic Acrylic Material for Hydrophobic Acrylic Material for

Fabrication of IOLsFabrication of IOLs

1.1. Ophthalmology Department, Kaplan Medical CenterOphthalmology Department, Kaplan Medical Center

2.2. Harlan Biotech IsraelHarlan Biotech Israel

Guy Kleinmann is a consultant for Hanita LensesGuy Kleinmann is a consultant for Hanita Lenses

To evaluate the biocompatibility of To evaluate the biocompatibility of a a

new hydrophobic IOL material; the new hydrophobic IOL material; the

Benz-HF1 Natural YellowBenz-HF1 Natural Yellow, Using , Using the the

SeeLens IOL (Hanita, Israel) as a SeeLens IOL (Hanita, Israel) as a platformplatform

PurposePurpose

MethodsMethods

10 NZW rabbits10 NZW rabbits

Each rabbit was randomly implanted Each rabbit was randomly implanted with the with the

new hydrophobic IOL in one eye and new hydrophobic IOL in one eye and B-lensB-lens

IOL (Hanita, Israel)IOL (Hanita, Israel) in the fellow eyein the fellow eye

Follow up: 1D, 1W, 1M, 3M, 6MFollow up: 1D, 1W, 1M, 3M, 6M

Each follow up included: Each follow up included:

o PhotographyPhotography

o Slit lamp clinical evaluation Slit lamp clinical evaluation

At the end of the study:At the end of the study:

o Enucliation of the eyeEnucliation of the eye

o Explantion of the lensExplantion of the lens

o Histological evaluation of the eyeHistological evaluation of the eye

o SEM/EDS of the explanted IOLsSEM/EDS of the explanted IOLs

Light microscopy analysis Light microscopy analysis (all IOLs)(all IOLs)

Transmission spectrum Transmission spectrum (half of the IOLs)(half of the IOLs)

Scanning electron microscopic + energy Scanning electron microscopic + energy

dispersive x-ray (SEM/EDX) dispersive x-ray (SEM/EDX) (half of the IOLs)(half of the IOLs)

Two non-implanted IOLs of each IOL Two non-implanted IOLs of each IOL

served as served as negative controlsnegative controls

Analysis of the explanted IOLs:Analysis of the explanted IOLs:

Methods – cont.Methods – cont.

Results: MacroscopicResults: Macroscopic 11 monthmonth

Control New Hydrophobic

ResultsResultsSlit lamp evaluationSlit lamp evaluation

Control

New Hydrophobic

1 month 3 months 6 months

ResultsResults

Test Control

Decentration 1/10 2/10

Tilt 0/10 1/10

Pigments on the surface of the IOL

2/10 5/10

Soemmering’s ring

10/10 10/10

PCO 10/10 10/10

6 months slit lamp evaluation6 months slit lamp evaluation

Histopathological resultsHistopathological results

FINDING

B-LensB-Lens(Control Product)(Control Product)

Hydrophobic IOLHydrophobic IOL(Test Product)(Test Product)

Control Eye Test Eye

n=10 n=10

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)

Histology summaryHistology summary

No treatment related nor material related changes were noted

All reported changes had comparable incidence in both groups

SEM/EDS of explanted IOLsSEM/EDS of explanted IOLs

Control New Hydrophobic

Explanted IOLs- summaryExplanted IOLs- summary

The Investigated hydrophobic The Investigated hydrophobic

study IOLs were study IOLs were superiorsuperior in in

comparison to the control lensescomparison to the control lenses

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

DiscussionDiscussion

ConclusionConclusion

The Benz-HF1 Natural Yellow material, using the

SeeLens IOL platform (Hanita, Isreal), demonstrated

excellent biocompatibility in the Rabbit model of ocular

implantation test