evaluation of the bunnylens af as the platform for the toric ......2011/05/01 · dr. adi michaeli...
TRANSCRIPT
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
Introduction
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
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
BunnyLens AF Specifications
2% transmittance for 400nm
90% transmittance for 460nm
Light Transmittance
Violet filtering IOL - BunnyLens AF
Blue-light filtering IOL
Full range of Scotopic vision
Full range of Photopic vision
Violet filtering-Light Transmittance
Aspheric Optics
The four-point-fixation of the haptics is
designed to provide stability, already
proven clinically with the BunnyLens IOL
IOL Design
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
Patients follow-up
1 day 7-10 days
2-3 months
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
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
Rotational stability
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
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
No complications or adverse events were
observed
Complications and Adverse
Events
BunnyLens AF demonstrated high
rotational stability, and was found to be
suitable as a platform for the toric IOL
Conclusions
Thank You !