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IC-8™ Small-Aperture
Intraocular Lens
Nicholas Tarantino, O.D.
Chief Clinical and Regulatory
Officer
Depth of Focus Comparison
Optical Modeling, 3.0 mm Pupil
IC-8™Small Aperture IOL Extended Depth of Focus (TC -0.75D)
Standard Mono-focal
0.0 D -0.5 D -1.0 D -1.5 D -2.0 D -2.5 D
20/50
20/40
20/30
20/20
20/10
20/50
20/40
20/30
20/20
20/10
20/50
20/40
20/30
20/20
20/10
2
Diffractive Bi-focal
0.0 D -0.5 D -1.0 D -1.5 D
(66 cm)
-2.0 D
(50 cm)
-2.5 D
(40 cm)
0.0 D -0.5 D -1.0 D -1.5 D -2.0 D -2.5 D
IC-8™ IOL Extends Depth of Focus
• Defocus curve results from IC-8 IOL patients demonstrate broad range of
vision across near, intermediate and far distances versus a monofocal IOL
• Mean post-op MRSE at their last follow-up was -0.14 D +/- 0.52
Data courtesy of Robert Ang, MD
-0.20
-0.10
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
1.10
Acuity(LogMAR)
Defocus Lens Power
Simulated Monofocal IOL Ang 6M (n=8)
Far Near
20/25
20/40
Forgiving Design
• Combining with a small amount of myopia further extends depth of
focus
• If refractive target is missed, patient still achieve good range from
near
Data courtesy of Robert Ang, MD
-0.20
-0.10
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
1.10
Acuity(LogMAR)
Defocus Lens Power
Simulated Monofocal IOL Ang 6M (n=8)
Far Near
20/25
20/40
Near Visual Acuity
Uncorrected and Target Corrected
• Mean achieved UCNVA in the IC-8™ eye is J2, with refractive target
correction to -0.75 D mean improves to J1
• 89% of eyes achieved J1 or better TCNVA
22%
89%
100% 100%
89%
100% 100% 100%
0%
20%
40%
60%
80%
100%
>=J1 >=J2 >=J3 >=J5
Uncorrected & Target Corrected
Near Visual Acuity
UCNVA IE TCNVA IE
Data courtesy of Robert Ang, MD (n=9)
TCNVA: Visual acuity tested at -0.75 DS
Intermediate and Distance Acuity
Uncorrected and Target Corrected
• Mean achieved UCIVA, TCIVA, UCDVA and TCDVA in the IC-8™ eye is
20/20
• 100% of patients achieved 20/25 TCIVA and TCDVA
44%
67%
100% 100%
78%
100% 100% 100%
0%
20%
40%
60%
80%
100%
>=20/20 >=20/25 >=20/32 >=20/40
Uncorrected & Target Corrected
Intermediate Visual Acuity
UCIVA IE TCIVA IE
Data courtesy of Robert Ang, MD (n=9)
TCIVA and TCDVA: Visual acuity tested at -0.75 DS
67%
78%
100% 100%
56%
100% 100% 100%
0%
20%
40%
60%
80%
100%
>=20/20 >=20/25 >=20/32 >=20/40
Uncorrected & Target Corrected
Distance Visual Acuity
UCDVA IE TCDVA IE
Reported Visual Symptoms Remain Low
• Comparison between eyes shows similar scores for
all symptoms ratings
Data courtesy of Robert Ang, MD (n=9)
QUESTIONAIRE:
Patients were asked to
rate the presence of
visual symptoms on a
scale of 0 to 7
(0=None, 7=Severe)
None
Severe
0
1
2
3
4
5
6
7
Subjective Symptoms
IC-8 Eye (IE) vs. Fellow Eye (FE)
Month 12 FE
Month 12 IE
No Surgical Adaptation Needed
• Personal cataract removal technique
acceptable
– Choice of manual or femtosecond
laser-created incisions, capsulotomy
and lens fragmentation
• In the bag lens placement same as any
standard IOL:
– Haptics at 6 and 12 o’clock
• To date no centration issues experienced
with any version of the lens
Ocular Assessment & Posterior Segment
Procedures Possible
• Imaging through the IOL mask central
aperture is possible minimal differences
noted between IC-8 IOL and fellow monofocal
IOL implanted eyes1 (Visual field, fundus
photography, and retinal OCT)
• Technicians reported ocular assessments
were successful and required no different
instructions for IC-8 IOL eyes
• Vitreoretinal surgery in eyes implanted with
the IC-8 IOL can be performed with ease and
good visibility2,3
1- Data courtesy of Dr. Amadeo Veloso
2- Results from a an animal study conducted by Dr. Barry Kupperman is Professor of Ophthalmology and Biomedical Engineering;
Chief, Retina Service; Vice-Chair, Clinical Research, Ophthalmology at UC Irvine School of Medicine
3-Personal experience in one patient form Professor Burkhardt Dick, MD
Fellow Eye
IC-8 IOL Eye
Images courtesy of Prof. Günther Grabner
Summary
– Reliably extends depth of focus
– Provides excellent visual acuity across all distances
– Is forgiving of refractive misses
– Tolerant to 1.50 D of astigmatism
– Has a low-level of visual symptoms
– Requires no surgical adaptation
– Is free of centration issues
– Allows posterior segment ocular assessments and
secondary procedures post implantation
THANK YOU
11

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AcuFocus

  • 1. IC-8™ Small-Aperture Intraocular Lens Nicholas Tarantino, O.D. Chief Clinical and Regulatory Officer
  • 2. Depth of Focus Comparison Optical Modeling, 3.0 mm Pupil IC-8™Small Aperture IOL Extended Depth of Focus (TC -0.75D) Standard Mono-focal 0.0 D -0.5 D -1.0 D -1.5 D -2.0 D -2.5 D 20/50 20/40 20/30 20/20 20/10 20/50 20/40 20/30 20/20 20/10 20/50 20/40 20/30 20/20 20/10 2 Diffractive Bi-focal 0.0 D -0.5 D -1.0 D -1.5 D (66 cm) -2.0 D (50 cm) -2.5 D (40 cm) 0.0 D -0.5 D -1.0 D -1.5 D -2.0 D -2.5 D
  • 3. IC-8™ IOL Extends Depth of Focus • Defocus curve results from IC-8 IOL patients demonstrate broad range of vision across near, intermediate and far distances versus a monofocal IOL • Mean post-op MRSE at their last follow-up was -0.14 D +/- 0.52 Data courtesy of Robert Ang, MD -0.20 -0.10 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00 1.10 Acuity(LogMAR) Defocus Lens Power Simulated Monofocal IOL Ang 6M (n=8) Far Near 20/25 20/40
  • 4. Forgiving Design • Combining with a small amount of myopia further extends depth of focus • If refractive target is missed, patient still achieve good range from near Data courtesy of Robert Ang, MD -0.20 -0.10 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00 1.10 Acuity(LogMAR) Defocus Lens Power Simulated Monofocal IOL Ang 6M (n=8) Far Near 20/25 20/40
  • 5. Near Visual Acuity Uncorrected and Target Corrected • Mean achieved UCNVA in the IC-8™ eye is J2, with refractive target correction to -0.75 D mean improves to J1 • 89% of eyes achieved J1 or better TCNVA 22% 89% 100% 100% 89% 100% 100% 100% 0% 20% 40% 60% 80% 100% >=J1 >=J2 >=J3 >=J5 Uncorrected & Target Corrected Near Visual Acuity UCNVA IE TCNVA IE Data courtesy of Robert Ang, MD (n=9) TCNVA: Visual acuity tested at -0.75 DS
  • 6. Intermediate and Distance Acuity Uncorrected and Target Corrected • Mean achieved UCIVA, TCIVA, UCDVA and TCDVA in the IC-8™ eye is 20/20 • 100% of patients achieved 20/25 TCIVA and TCDVA 44% 67% 100% 100% 78% 100% 100% 100% 0% 20% 40% 60% 80% 100% >=20/20 >=20/25 >=20/32 >=20/40 Uncorrected & Target Corrected Intermediate Visual Acuity UCIVA IE TCIVA IE Data courtesy of Robert Ang, MD (n=9) TCIVA and TCDVA: Visual acuity tested at -0.75 DS 67% 78% 100% 100% 56% 100% 100% 100% 0% 20% 40% 60% 80% 100% >=20/20 >=20/25 >=20/32 >=20/40 Uncorrected & Target Corrected Distance Visual Acuity UCDVA IE TCDVA IE
  • 7. Reported Visual Symptoms Remain Low • Comparison between eyes shows similar scores for all symptoms ratings Data courtesy of Robert Ang, MD (n=9) QUESTIONAIRE: Patients were asked to rate the presence of visual symptoms on a scale of 0 to 7 (0=None, 7=Severe) None Severe 0 1 2 3 4 5 6 7 Subjective Symptoms IC-8 Eye (IE) vs. Fellow Eye (FE) Month 12 FE Month 12 IE
  • 8. No Surgical Adaptation Needed • Personal cataract removal technique acceptable – Choice of manual or femtosecond laser-created incisions, capsulotomy and lens fragmentation • In the bag lens placement same as any standard IOL: – Haptics at 6 and 12 o’clock • To date no centration issues experienced with any version of the lens
  • 9. Ocular Assessment & Posterior Segment Procedures Possible • Imaging through the IOL mask central aperture is possible minimal differences noted between IC-8 IOL and fellow monofocal IOL implanted eyes1 (Visual field, fundus photography, and retinal OCT) • Technicians reported ocular assessments were successful and required no different instructions for IC-8 IOL eyes • Vitreoretinal surgery in eyes implanted with the IC-8 IOL can be performed with ease and good visibility2,3 1- Data courtesy of Dr. Amadeo Veloso 2- Results from a an animal study conducted by Dr. Barry Kupperman is Professor of Ophthalmology and Biomedical Engineering; Chief, Retina Service; Vice-Chair, Clinical Research, Ophthalmology at UC Irvine School of Medicine 3-Personal experience in one patient form Professor Burkhardt Dick, MD Fellow Eye IC-8 IOL Eye Images courtesy of Prof. Günther Grabner
  • 10. Summary – Reliably extends depth of focus – Provides excellent visual acuity across all distances – Is forgiving of refractive misses – Tolerant to 1.50 D of astigmatism – Has a low-level of visual symptoms – Requires no surgical adaptation – Is free of centration issues – Allows posterior segment ocular assessments and secondary procedures post implantation