Transcript Document 7494017

P030002
CrystaLens™ Model AT-45
Multipiece Silicone Posterior
Chamber Accommodating IOL
Bernard P. Lepri, OD, MS, MEd
Clinical Reviewer
FDA/DOED
Information for Question #1
Accommodative Substudies
A small subset of five subjects
implanted bilaterally with the
CrystaLens™ at a single clinical site
underwent additional testing in an
effort to document the mechanism of
action of the CrystaLens™, i.e.,
accommodation achieved by the
forward and backward movement of
the lens optic along the axis of the eye.
Testing included:
•dynamic retinoscopy
• defocus
• near point evaluation
• near vision (DxRx cycloplegia)
• power mapping (Tracey Wavefront)
•anterior chamber depth ( A-scan )
(cyclopentolate) / 6% pilocarpine.
Accommodative Substudy Summary (n = 10)
Mean
(±SD)
∆ ACD
In mm
0.56mm
(0.39)
∆ ACD
In D*
1.01 D
(0.70)
Tracey
Abberrometer
Accommodation
0.72 D
(0.83)
Dynamic Retinoscopy
3.14
(0.81)
Defocus
2.43
(0.46)
Lagenbacher: 1.0mm = 1.8D
Correlation of Accommodative
Studies
Rcorr
Abb Vs ACD ∆ (D)
0.662
Abb. Vs retinoscopy
-0.54
Retinoscopy Vs defocus
0.07
Abb. Vs defocus-
0.01
ACD ∆(D) Vs defocus
0.07
Question #1
This is the first IOL that proposes
accommodation as its mechanism of action.
a). Do the effectiveness data support a
claim of accommodation?
b). What performance issues should be
considered both generally and for
product labeling?
Information for Question #2
The stability of the CrystaLens hinge was
demonstrated by:
a). in-vitro dynamic fatigue testing up to 1-year
b). an analysis of change Dx MRSE between
consecutive examinations
c). intermediate visual acuity between
consecutive examinations
Stability of MRSE
Primary Eyes
∆ MRSE
 0.50 D95% CI
 1.00 D 95% CI
Mean SD
95% CI mean,
Median
 Range
Form 3 to 4
%* (n)
Form 4 to 5
%* (n)
84.1% (206)
(79.5%, 88.7%)
85.6% (202)
(81.1%, 90.1%)
96.3% (236)
(94.0%, 98.7%)
96.2% (227)
(93.7%, 98.6%)
-0.03  0.52
(-0.09, 0.04)
0.00
-3.38 to 1.25
0.13  0.45
(0.08, 0.19)
0.00
-1.25 to 2.75
Stability of Uncorrected Near Visual Acuity
(UNVA) US Eyes
One-Year Consistent Cohort
∆ UCVA
Form 3 to 4
% (n)
Form 4 to 5
% (n)
Decrease  2 lines
± 1 line
Increase  2 lines
6.1% ( 14)
80.8% (185)
13.1% ( 30)
4.4% ( 10)
81.1% (185)
14.5% ( 33)
Mean  SD
95% CI for mean
Median
Range
0.27  1.33
(0.10, 0.44)
0
-3 to 5
0.29  1.16 (0.14,
0.44)
0
-4 to 3
Intermediate Visual Acuity Through
Distance Correction (DCIVA) US Eyes
Visual
Acuity
Primary Eyes
N = 241N
(Missing) = 5
Fellow Eyes
N = 127N
(Missing) = 0
n
%
n
%
20/20 or better
20/25 or better
20/32 or better
20/40 or better
192
230
239
240
79.7
95.4
99.2
99.6
104
121
126
126
81.9
95.3
99.2
99.2
20/41 to 20/100
Worse than
20/100
1
0
0.4
0.0
1
0
0.8
0.0
Question #2
Do you believe that the sponsor has
demonstrated the stability of the hinge,
and therefore the stability of the
accommodative refractive effect?
Question #3
Does the panel recommend any other
modifications to the proposed :
a). Physician labeling?
b). Patient labeling?
Question # 4
Do the data in PMA P030002 support
the proposed indication statement?
Indications for use:
Primary implantation for the visual
correction of aphakia in adult patients
with cataracts.
Provide improved near, intermediate,
and distance vision without
spectacles.