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Kenneth Lipstock, MD
Lipstock LASIK and Cataract Center
Richmond, Virginia
www.lipstocklaser.com
Introduction: MAST 1 Study
 Prospective evaluation of 53 consecutive patients with nanoFLEX
(STAAR aspheric single piece collamer iol) between 7/09 and
5/10 (Lipstock)
 Measured 6-8 weeks Post-Op
 (“nanoFLEX MAST”)

 Prospective evaluation of 47 consecutive patients presenting in
office for routine follow up 7/09 to 5/10
 All with STAAR non-aspheric collamer plate IOL(CC4204BF) from 7/01 to 1 1/08
(Lipstock)
 (“BF MAST”)
MAST 1 Study
Distance-Corrected Bilateral Average Near (40cm) &
Intermediate (80cm) Visual Acuity
0
10
20
30
40
50
60
nanoFLEX nanoFLEX
20/20 Subset
BF Spherical
SnellenAcuity20/-
Near
Intermediate
20/53 20/53 20/52
20/24 20/24
20/26
MAST 2 STUDY
 To evaluate the near and intermediate
visual outcomes of patients undergoing
routine cataract surgery with
phacoemulsification and monofocal IOL
placement in the capsular bag in at least
one eye
Purpose:
Methods
 Prospective, multicenter evaluation of over 100
consecutive patients undergoing cataract surgery
with different monofocal IOLs
 Study evaluation consisted of a single visit 1-2
months postoperatively
 Outcome measures included monocular DC near
and intermediate VA and binocular acuities if eyes
were bilaterally implanted with the same lens
Inclusion Criteria
 Patients who underwent routine cataract surgery
with phacoemulsification and monofocal IOL
placement in the capsular bag in at least one eye
within the last 36 months
 At least 1 month postop before follow-up evaluation
 All Patients must have a DCVA of 20/25 or better
nanoFLEX Distance-Corrected Bilateral
Average Near & Intermediate VA
0
10
20
30
40
50
nanoFLEX
SnellenAcuity20/-
Near
Intermediate
20/50
20/24
NanoFLEX Binocular VA at Near (40cm) and
Intermediate (80 cm)
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
20/16 20/20 20/25 20/32 20/40 20/50 20/63 20/80
10%
22%
48%
21%
2%
10%
21%
40%
24%
5%
%ofPatients
Intermediate (Average = 20/24) Near ( Average = 20/50)
n = 63
NanoFLEX Binocular VA at Near (40cm) and
Intermediate (80 cm) – Cumulative Eyes
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
20/16 20/20 20/25 20/32 20/40 20/50 20/63 20/80
10%
32%
79%
100%
2%
11%
32%
71%
95%
100%
%ofPatients
Intermediate ( Average = 20/24) Near (Average = 20/50)
n = 63
All Lenses
Distance-Corrected Bilateral Average Near & Intermediate VA
0
10
20
30
40
50
60
Near Intermediate
SnellenAcuity20/-
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%
%ofPatients
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%
%ofPatients
NanoFLEX (n=63)
AMO Tecnis sililcone aspheric 3
piece iol (n=61)
p = <0.001
Comparison to Multifocal and
Accommodative IOLs
Lens Investigator
Binocular
Distance Corrected
Near VA at 40cm
Binocular
Distance Corrected
Intermediate VA at 80cm
NanoFlex Lipstock 20/50 20/24
Restor D1
Santhiago 20/21 -
Maxwell - 20/30 at 70cm
Alfonso 20/18 20/28 at 70cm
Kohnen 20/22 20/29 at 70cm
Tecnis MF Hutz 20//27 20/26
Crystalens
Pepose 20/32 20/17
Alio 20/25 -
Synchrony Bohorquez 20/27 -
Conclusions
 The nanoFLEX lens offers patients a highly
effective cost-effective alternative to the “premium
channel” IOLs, by providing some near vision
and excellent intermediate vision.
 An additional prospective study designed to
evaluate how best to utilize the intrinsic properties
of the nanoFLEX to optimize visual outcomes with
a “blended vision” approach was subsequently
conducted.

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Prospective Evaluation of Near and Intermediate Visual Outcomes with Monofocal IOLs

  • 1. Kenneth Lipstock, MD Lipstock LASIK and Cataract Center Richmond, Virginia www.lipstocklaser.com
  • 2. Introduction: MAST 1 Study  Prospective evaluation of 53 consecutive patients with nanoFLEX (STAAR aspheric single piece collamer iol) between 7/09 and 5/10 (Lipstock)  Measured 6-8 weeks Post-Op  (“nanoFLEX MAST”)   Prospective evaluation of 47 consecutive patients presenting in office for routine follow up 7/09 to 5/10  All with STAAR non-aspheric collamer plate IOL(CC4204BF) from 7/01 to 1 1/08 (Lipstock)  (“BF MAST”)
  • 3. MAST 1 Study Distance-Corrected Bilateral Average Near (40cm) & Intermediate (80cm) Visual Acuity 0 10 20 30 40 50 60 nanoFLEX nanoFLEX 20/20 Subset BF Spherical SnellenAcuity20/- Near Intermediate 20/53 20/53 20/52 20/24 20/24 20/26
  • 4. MAST 2 STUDY  To evaluate the near and intermediate visual outcomes of patients undergoing routine cataract surgery with phacoemulsification and monofocal IOL placement in the capsular bag in at least one eye Purpose:
  • 5. Methods  Prospective, multicenter evaluation of over 100 consecutive patients undergoing cataract surgery with different monofocal IOLs  Study evaluation consisted of a single visit 1-2 months postoperatively  Outcome measures included monocular DC near and intermediate VA and binocular acuities if eyes were bilaterally implanted with the same lens
  • 6. Inclusion Criteria  Patients who underwent routine cataract surgery with phacoemulsification and monofocal IOL placement in the capsular bag in at least one eye within the last 36 months  At least 1 month postop before follow-up evaluation  All Patients must have a DCVA of 20/25 or better
  • 7. nanoFLEX Distance-Corrected Bilateral Average Near & Intermediate VA 0 10 20 30 40 50 nanoFLEX SnellenAcuity20/- Near Intermediate 20/50 20/24
  • 8. NanoFLEX Binocular VA at Near (40cm) and Intermediate (80 cm) 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 20/16 20/20 20/25 20/32 20/40 20/50 20/63 20/80 10% 22% 48% 21% 2% 10% 21% 40% 24% 5% %ofPatients Intermediate (Average = 20/24) Near ( Average = 20/50) n = 63
  • 9. NanoFLEX Binocular VA at Near (40cm) and Intermediate (80 cm) – Cumulative Eyes 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 20/16 20/20 20/25 20/32 20/40 20/50 20/63 20/80 10% 32% 79% 100% 2% 11% 32% 71% 95% 100% %ofPatients Intermediate ( Average = 20/24) Near (Average = 20/50) n = 63
  • 10. All Lenses Distance-Corrected Bilateral Average Near & Intermediate VA 0 10 20 30 40 50 60 Near Intermediate SnellenAcuity20/- 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
  • 11. 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% %ofPatients NanoFLEX (n=63) AMO Tecnis sililcone aspheric 3 piece iol (n=61) p = 0.006 p = 0.112
  • 12. 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% %ofPatients NanoFLEX (n=63) AMO Tecnis sililcone aspheric 3 piece iol (n=61) p = <0.001
  • 13. Comparison to Multifocal and Accommodative IOLs Lens Investigator Binocular Distance Corrected Near VA at 40cm Binocular Distance Corrected Intermediate VA at 80cm NanoFlex Lipstock 20/50 20/24 Restor D1 Santhiago 20/21 - Maxwell - 20/30 at 70cm Alfonso 20/18 20/28 at 70cm Kohnen 20/22 20/29 at 70cm Tecnis MF Hutz 20//27 20/26 Crystalens Pepose 20/32 20/17 Alio 20/25 - Synchrony Bohorquez 20/27 -
  • 14. Conclusions  The nanoFLEX lens offers patients a highly effective cost-effective alternative to the “premium channel” IOLs, by providing some near vision and excellent intermediate vision.  An additional prospective study designed to evaluate how best to utilize the intrinsic properties of the nanoFLEX to optimize visual outcomes with a “blended vision” approach was subsequently conducted.