evaluation of visual outcomes of monovision patients bilaterally implanted with nanoflex collamer...
TRANSCRIPT
Kenneth Lipstock, MD
Lipstock LASIK and Cataract Center
Richmond, Virginia
www.lipstocklaser.com
Introduction
The MAST Study demonstrated that the
nanoFLEX (STAAR aspheric single piece
collamer iol) provided optimal vision at
intermediate and satisfactory at near Intermediate (80cm) binocular DCVA = 20/24
Near (40cm) binocular DCVA = 20/50
Present study designed to evaluate how best to
utilize the intrinsic properties of the nanoFLEX
to optimize visual outcomes
All LensesDistance-Corrected Bilateral Average Near &
Intermediate VA
0
10
20
30
40
50
60
Near Intermediate
Sn
ell
en
Acu
ity 2
0/-
NanoFLEX (n=63)
AMO Tecnis sililcone aspheric 3 piece iol (n=61)
20/50
20/24
20/28
20/52
p = 0.832
p = 0.072
Binocular VA at Near (40 cm): All Lenses
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
20/40 or Better
20/50 or Better
20/63 or Better
20/80 or Better
32%
71%
95%100%
46%
72%
79%
93%
% o
f P
ati
en
ts
NanoFLEX (n=63)
AMO Tecnis sililcone aspheric 3 piece iol (n=61)
p = 0.006
p = 0.112
Binocular VA at Intermediate (80 cm): All
Lenses
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
20/20 or Better 20/25 or Better 20/32 or Better 20/40 or Better
35%
79%
100% 100%
34%
74%
82%
93%
% o
f P
ati
en
ts
NanoFLEX (n=63)
AMO Tecnis sililcone aspheric 3 piece iol (n=61)
p = <0.001
Purpose
To evaluate the visual outcomes of
patients undergoing routine cataract
surgery with phacoemulsification
followed by bilateral implantation of
aspheric (nanoFLEX) intraocular lenses
(IOLs) using blended vision.
Methods Prospective evaluation of patients who had undergone
bilateral phacoemulsification with implantation of nanoFLEX IOLs.
All patients with a DCVA 20/25 or better in each eye underwent ETDRS testing under controlled lighting utilizing the Functional Vision Analyzer (Stereo Optical) for binocular UCDVA and UCNVA and repeated for the dominant eye.
MN Reading Cards were used to measure binocular UCNVA and UCIVA and reading speed.
Patient satisfaction questionnaire administered
IRB approval obtained
Key Inclusion/Exclusion
Inclusion Criteria: DCVA of 20/25 or better in both eyes
Spherical equivalent in the dominant eye to be
± 0.50 or less and in the nondominant eye
between -0.88 and -1.87 and cyl ± 0.75 both eyes
Exclusion Criteria: No amblyopia or tropias or posterior capsular
opacification
All other ocular pathology allowed as long as DCVA ≤ 20/25 and no significant visual field loss
No LVC pre-op or post-op
Patient Baseline Characteristics 13 pts (ongoing study)
6 to 20 months post-op
69% male
Mean age 64 (52-73)
Pathology: dry eye, paracentral full thickness corneal scar, ABMD, AMD
Post Operative Refractions (means) Mean Spherical Equivalent
• Dominant = +0.02 D
• Non-dominant = -1.23 D Mean Cylinder
• Dom = 0.44 D
• Non-dom = 0.42
Mean Corrected Distance Vision (BCDVA)
• Dom= 20/16.8
• Non-dom = 20/18.6
Binocular UCVA
0%
20%
40%
60%
80%
100%
20/15 or Better 20/20 or Better 20/25 or Better 20/32 or Better 20/50 or Better
15%
38%
69%
85%
100%
61%
92%
100%
54%
100%
% o
f P
ati
en
ts
Near (40cm) Mean = 20/25Intermediate (80cm) Mean = 20/16Distance Mean = 20/19
Comparison of Reading Acuity at 40cm & 80cm
between nanoFLEX Blended Vision and Premium
IOLDistance Corrected Visual Acuities
nan
oF
LE
X B
V
ReS
TO
R D
1
¤
Syn
ch
ron
y
#
Cry
sta
Len
s
§
Tecn
is M
F ¥
nan
oF
LE
X B
V
ReS
TO
RD
1
*
Syn
ch
ron
y
#
Cry
sta
Len
s
§
Tecn
is M
F ¥
0
5
10
15
20
25
30
35
Mean
Sn
ell
en
Acu
ity
¤ Santhiago JCRS 11/10; # Bohorquez JCRS 11/10; § Pepose AJO 9/07; ¥ Hutz JRS 3/08; *Alfonso JCRS 5/09
Near 40cm Intermediate 80cm
20/25
20/21
20/23
20/32
20/27
20/18
20/28
20/17 20/17
(Letter Acuity (70cm )
20/26
Reading Speed
Reading Speed of at least 80 wpm:○ The lower limit for comfortable recreational
reading (Radner, Richter-Mueksch, Rubin, West)
Maximum reading speed beyond approximately 150 WPM is likely more a measure of brain function than optical acuity
.4 LogMAR (20/50)○ Reading speed at this print size commonly
reported because it is newspaper print size.
Comparison of Reading Speed at
40cm
using 0.4 LogMAR Print Size (20/50)
0
20
40
60
80
100
120
140
160
180
200
nanoFLEX ReSTOR D1 ** Synchrony # CrystaLens ¥ TetraFlex ¥
179
360184
70
90WP
M
** Santhiago JCRS 11/10; # Bohorquez JCRS 11/10; + Pepose AJO 9/07; ¥ Brown JCRS 10/09
How Often do You Wear Glasses?
0%
10%
20%
30%
40%
50%
60%
70%
80%
Never/Almost Never Sometimes
55%
18%
27%
% o
f P
ati
en
ts
73% Never or Almost Never
Patient Satisfaction with Near Vision
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Reading Newspapers
Computer Medicine Bottles
Shaving/Doing Make-up
Cooking/Sewing
3.43.6
2.5
4.0
3.5
MeanScore
No
Difficulty
Extreme
Difficulty
4= Very good / 3= good / 2 = poor / 1 = very poor
Patient Satisfaction with Distance Vision
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Day Driving Night Driving Difficult Weather Driving
TV Out of home activities
4.0
3.4 3.5
4.03.9
MeanScore
4= Very good / 3= good / 2 = poor / 1 = very poor
No
Difficulty
Extreme
Difficulty
Stereopsis
Mean NC Far Stereo = 51 sec arc
Mean UC Far Stereo = 154 sec arc
Mean NC Near Stereo= 64 sec arc
Mean UC Near Stereo= 278 sec arc ○ Dropping 1 patient with abnormal near stereo with NC mean: 221
Visual Disturbance with Depth Perception Scale 0-4 (Severe to None) = 3.9
Stereopsis in other Pseudophakic Blended Vision Studies:
○ Zhang JCRS 3/11: Mean Near Stereopsis= 127
○ Finkelman JCRS 6/09 Mean Near Stereopsis=176
nanoFLEX Blended Vision
Patient Satisfaction
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Would recommend to family/friendsWould have blended vision again
100% 100%
% Patients Responding
Positively
Patient Satisfaction
nanoFLEX
Blended
Vision
ReStor D1 Investigator
Vision without
Eyeglasses – Very
Good
100% Lipstock
Would have Blended
Vision Again100% Lipstock
Would recommend BV
to Family/Friend100% Lipstock
Would have the
Procedure Again94%
Maxwell
JCRS 12/09
Extreme Difficulty
nanoFLEX ReStor D1 Crystalens
Night Vision 0% 2%* 2%***
Driving in
Difficult
Weather
0% 4%** -
* Maxwell JCRS 12/09
** Kohnen JCRS 12/09
*** FDA Crystalens Study
Conclusions Blended Vision (moderate monovision)
with STAAR Collamer Monofocal one piece IOL (nanoFlex) offers:
Excellent distance acuity
Good reading acuity
Excellent intermediate reading acuity
Comfortable reading speed for newspaper print size
High rate of spectacle independence
Extremely high patient satisfaction
nanoFLEX Blended Vision can be offered to patients with pre-op pathologies such as dry eye, ABMD and AMD – more importantly, unlike multifocal iols, if new ocular pathologies occur over time BCVA can always be obtained with eyeglasses
Pan-focal visual outcomes comparable to “premium IOLs”
Reduced Cost to Patient Great option for patients who can’t afford “premium IOL” presbyopic
corrections