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Evaluation of the BunnyLens AF as the platform for the toric IOL Rotational stability phase I Adi Michaeli M.D. The Tel-Aviv Medical Center Microsurgery of the eye Eilat, 2010

Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

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Page 1: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Evaluation of the BunnyLens AF as the platform

for the toric IOL

Rotational stability – phase I

Adi Michaeli M.D.

The Tel-Aviv Medical Center

Microsurgery of the eye

Eilat, 2010

Page 2: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Introduction

Page 3: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

BunnyLens

Spherical

Fits through 2.4mm

incision

BunnyLens AF

Aspheric

Fits through 1.8mm

incision

Introduction

Will be used as the

platform for the toric IOL

Page 4: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

BunnyLens AF Specifications

Hydrophilic acrylic [HEMA / EOEMA]

with UV blocking and violet filtering

chromopore

• Refractive index – 1.46 (35⁰C)

• YAG laser – compatible

Material

10.5D – 30D in 0.5D increments

31D – 35D in 1D increments

Power range

MICS 1.8 mm

Incision size

Total diameter – 11 mm

Optic diameter – 6 mm

Angulation – 50

Double square edge

Geometry

Page 5: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

BunnyLens AF Specifications

Page 6: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

2% transmittance for 400nm

90% transmittance for 460nm

Light Transmittance

Violet filtering IOL - BunnyLens AF

Blue-light filtering IOL

Page 7: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Full range of Scotopic vision

Full range of Photopic vision

Violet filtering-Light Transmittance

Page 8: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Aspheric Optics

Page 9: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

The four-point-fixation of the haptics is

designed to provide stability, already

proven clinically with the BunnyLens IOL

IOL Design

Page 10: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

A non-randomized, open, prospective,

dual-center study

Study Design

2-3- Month FU/ # of patients

Surgeon Center

19/20* Dr. Adi Michaeli

Sourasky Medical Center,

Israel

17/20** Prof. Jan Novak Pardubice Regional

Hospital, Czech Republic

* 2 months follow-up

** 3 months follow-up

Page 11: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Patients follow-up

1 day 7-10 days

2-3 months

Page 12: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Safety (according to ISO 11979-7 2006)

Complications and Adverse Events (equal to or less then the

allowed rate)

Efficacy

Rotational stability qualitative test

Safety and Efficacy Evaluation

Page 13: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Dr. Michaeli

A-const used: 118.4

Average deviation from

targeted refraction:

-0.01D

Prof. Novak

A-const used: 119.4

Average deviation from

targeted refraction:

-1.02D

Refraction 2-3 months post-op

Page 14: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Rotational stability

Page 15: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Rotational stability – Dr. Michaeli

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

מיקום העדשה חודשיים מיקום העדשה יום

De

gre

es

of

rota

tio

n

Follow-up

Rotation of the BunnyLens AF in the capsule

Page 16: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

excellent rotational stability of the lens in the capsular bag

Average rotation = 2.53° Average deviation 1.09°

Maximum: 5 degrees

Minimum: 0 degrees

Rotational stability – Prof. Novak

No Rotation (°)

1 2°

2 1,5°

3 2°

4 5°

5 4°

6 3°

7 4°

8 2,5°

9 2°

10 3°

11 5°

12 1°

13 0°

14 2°

15 1°

16 3°

17 2°

1st day 3 months

Page 17: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

No complications or adverse events were

observed

Complications and Adverse

Events

Page 18: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

BunnyLens AF demonstrated high

rotational stability, and was found to be

suitable as a platform for the toric IOL

Conclusions

Page 19: Evaluation of the BunnyLens AF as the platform for the toric ......2011/05/01  · Dr. Adi Michaeli 19/20* Sourasky Medical Center, Israel Pardubice Regional Prof. Jan Novak 17/20**

Thank You !