Ophthalmology . HOYA Surgical
HOYA SURGICAL
ISERT®
HOYA ISERT® 250 (CLEAR) AND 251 (YELLOW)

iSert® is an aspheric proven hydrophobic acrylic one-piece IOL, fully preloaded in a single-use screw type IOL delivery system made to simplify cataract surgery.

 

Indeed, iSert® is a simpler, faster and more predictable alternative to manually loaded IOL delivery systems [1,2] improving efficiency and productivity [3,4]. Moreover, it has a sharp optic edge [5], that is designed to reduce posterior capsule opacification (PCO).

 

Specifications

Model name

iSert® 250 (Clear), iSert® 251 (Yellow)

Specification

UV and blue light filter (251); UV filter (250)

Optic material

Hydrophobic Acrylic (AF-1)

Optic design

Aspheric lens design, aberration correcting

Manufacturing

Lathe-cut and pad polished

Haptic material

Hydrophobic acrylic with blue PMMA chemically bonded haptics tips

Haptic Configuration

Modified-C loop, 5° angulation

Diameter (optic/OAL)

6.0 mm/12.5 mm

Power

+6.0 to +30.0 D (0.5 D steps)

Injector

iSert® preloaded

Front injector tip outer diameter

1.82mm

Nominal A-constant *

118.4

Optimized constants **

Haigis a0 = -0.542 a1 = 0.161 a2 = 0.204
Hoffer Q pACD = 5.30
Holladay 1 sf = 1.52
SRK/TA = 118.5

* The A-constant mentioned above is presented as a guideline only for lens power calculations. It is recommended that the A-constant measurement be customized based on the surgeon’s experience and measuring equipment.

** These optimized constants for the calculation of intraocular lens power published by ULIB on their website: http://ocusoft.de/ulib/c1.htm are calculated from 319 clinical results for model 250/251 as of October 31, 2016. These constants are based on actual surgical data and are provided by ULIB as a starting point for individual constant optimizations. The information available on the website is based on data originating from other users and not by HOYA Surgical Optics (HSO). HSO therefore does not warrant the correctness, completeness and currentness of the contents on the said website)Some of the products and/or specific features may not be registered in your country and thus may not be available there.

References

1. HOYA post-market clinical follow-up study evaluating safety and performance of HOYA IOLs in routine practice. Data on file. HOYA Medical Singapore Pie. Ltd. 2018. CSR_PMCF-101LONG_6mlr_070 92018.

2. Chung B. et al. Preloaded and non-preloaded intraocular lens delivery system and characteristics: human and porcine eyes trial. Int J Ophthalmol 2018:11:6-11.

3. HOYA Cartridge IFU. Available at: http://hoyasurgicaloptics.com/eu/professionals/eifu/. Accessed on 28 Mar 2019.

4. HOYA iSert® 254 IFU. Available at: http://hoyasurgicaloptics.com/eu/professionals/eifu/. Accessed on 28 Mar 2019.

5. Werner L. Tetz M. Edge profiles of currently available intraocular lenses and recent improvements. Eur Ophthalmic Rev 2009;3:74-76.

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Overview
HOYA ISERT® PY-60AD

iSert® PY-60AD is an aspheric hydrophobic acrylic 3-piece IOL which ensures efficiency and productivity, as it frees staff from time-consuming daily duties (e.g. cleaning/sterilization of reusable injector) [1,2]. It is made with a proven hydrophobic IOL material [3]and has a sharp optic edge designed to reduce posterior capsule opacification (PCO) [4].

 

Specifications

Model

iSert® PY-60AD

Specification

UV and blue light filter

Optic material

Hydrophobic acrylic (AF-1)

Optic design

Aspheric lens design, aberration correcting

Manufacturing

Lathe-cut and tumble polished

Haptic material

Blue PMMA chemically bonded

Haptic configuration

Modified C-loop, 5° angulation

Dimension (Optic/OAL)

6.0 mm / 12.5 mm

Power

+6.00 to +30.00 D (in 0.50 D increment)

Estimated A-constant*

118.4

Optimized constants**

Haigis a0 = -0.093

a1 = -0.023, a2 = 0.208

Hoffer Q pACD = 5.30

Holladay 1 sf = 1.54

SRK/TA = 118.6

SRK II A = 118.8

Front injector tip outer diameter

1.89 mm

Injector

iSert® preloaded

 

*The A-Constant mentioned above is presented as a guideline only for lens power calculations. It is recommended that the A-Constant measurement be customized based on the surgeon’s experience and measuring equipment.

** These optimized constants for the calculation of intraocular lens power published by ULIB on their website: http://ocusoft.de/ulib/c1.htm are calculated from 254 clinical results for model PY-60AD as of October 31, 2016. These constants are based on actual surgical data and are provided by ULIB as a starting point for individual constant optimizations. The information available on the website is based on data originating from other users and not by HOYA Surgical Optics (HSO). HSO therefore does not warrant the correctness, completeness and currentness of the contents on the said website)

Some of the products and/or specific features may not be registered in your country and thus may not be available there.

 

References

1. HOYA Cartridge IFU. Available at: http://hoyasurgicaloptics.com/eu/professionals/eifu/. Accessed on 27 Apr 2020.

2. HOYA-PS AF-1 PY-60AD/PC-60AD IFU. Available at: http://hoyasurgicaloptics.com/eu/professionals/eifu/. Accessed on 27 Apr 2020.

3. Data on file, HOYA Medical Singapore Pte. Ltd. 2018.

4. Werner L, Tetz M. Edge profiles of currently available intraocular lenses and recent improvements. Eur Ophthalmic Rev. 2009;3:74–76.

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Overview
VIVINEX™
HOYA VIVINEX™ ISERT® (XC1 / XY1)

The glistening-free hydrophobic Vivinex™ IOL preloaded in the proven Vivinex™ iSertⓇ injector provides unprecedented clarity of vision.


Vivinex™ iSert™
UNPRECEDENTED CLARITY OF VISION.

The preloaded Vivinex™ IOL provides unprecedented clarity of vision in the proven
Vivinex™ iSert® injector

Designed to provide outstanding optical quality, Vivinex™ offers unprecedented clarity of vision for patients suffering from cataract. Product quality, trust, dedication and attention to detail are deeply rooted in our Japanese heritage and with 1 million lenses sold worldwide, surgeons‘ trust in Vivinex™ is proven.

  • Glistening-free hydrophobic acrylic IOL material 1,3
  • Proprietary aspheric optic design for improved image quality 5
  • Active oxygen processing treatment and sharp optic edge to reduce PCO 1

1 Clinical Evaluation of the HOYA VivinexTM IOL, HOYA data on file DoF-PHIV-101-SP2-12mIR-31082018 (2018).
3 Glistening-free per Miyata scale; study result of the David J Apple International Laboratory for Ocular Pathology, University Hospital Heidelberg. Report on file.
5 Pérez-Merino P, Marcos S. Effect of intraocular lens decentration on image quality tested in a custom model eye. J Cataract Refract Surg. 2018;44(7):889–896.

 

Specifications:

Model Names Vivinex™ iSertⓇ XC1, Vivinex™ iSertⓇ XY1
Optic Material Hydrophobic acrylic Vivinex™ with UV-Filter (Model XC1) with UV- and blue light filter (Model XY1)
Optic Design Aspheric Design with sharp textured optic edge
Haptic Design Textured-rough haptic surface
Haptic Material Hydrophobic acrylic Vivinex™ with UV-Filter (Model XC1) with UV- and blue light filter (Model XY1)
Dimension (Optic/OAL) 6.00 mm / 13.00 mm
Power +6.00 to +30.00 D (in 0.50 D increments)
A-Constant 118.9
Nominal A-Constant 118.9
Optimized Optical constants

Haigis a0 = -0.278 a1 = 0.215 a2 = 0.201
Hoffer Q pACD = 5.71
Holladay 1 sf = 1.94
SRK/T A = 119.2

Front injector tip outer diameter 1.70 mm (Vivinex™ iSertⓇ preloaded)
 

Available in Saudi Arabia, UAE, Oman, Qatar, Kuwait and Lebanon

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Overview
HOYA VIVINEX™ TORIC (XY1A)
The glistening-free hydrophobic Vivinex™ Toric IOL preloaded in the proven iSert® injector offers unprecedented clarity of vision and outstanding rotational stability.

ivinex™ Toric
UNPRECEDENTED CLARITY AND ROTATIONAL STABILITY.

Designed for outstanding optical quality, Vivinex™ Toric provides proven rotational stability for precise astigmatism correction and unprecedented clarity of vision for cataract patients. Product quality, trust, dedication and attention to detail are deeply rooted in our japanese heritage.

Vivinex™ Toric offers the following benefits:

  • Glistening-free hydrophobic acrylic IOL material1,3
  • Proprietary aspheric optic design for improved image quality2
  • Active oxygen processing treatment and sharp optic edge to reduce PCO3
  • Vivinex™ Toric IOL preloaded in the proven VivinexTM iSert® injector system
  • Outstanding rotational stability4
  • Median rotation 1.1° [ range: 0.0° – 5.0° ]4
  • 100% of lenses (n=103) had 5° of rotation from their initial axis at end of surgery through all follow up visits at 1 hour, 1 week and 6 months4

1 Glistening-free per Miyata scale; study result of the David J Apple International Laboratory for Ocular Pathology, University Hospital Heidelberg. Report on file.
2 Pérez-Merino P, Marcos S. Effect of intraocular lens decentration on image quality tested in a custom model eye. J Cataract Refract Surg. 2018;44(7):889–896.
3 Data on File of Study PHIV-101-SP2: Clinical Evaluation of the HOYA Vivinex IOL (2018).
4 Schartmüller D, Schriefl S, Schwarzenbacher L, Leydolt C,Menapace R. True rotational stability of a single-piece hydrophobic intraocular lens. Br J Ophthalmol. 2018 Apr 17. pii: bjophthalmol-2017-311797. doi: 10.1136/ bjophthalmol-2017-311797.
 
Specifications:
 
Model Names Vivinex™ Toric XY1A
Optic Material Hydrophobic acrylic Vivinex™ with UV- and blue light filter
Optic Design Biconvex with sharp textured optic edge Anterior: Aspheric Design Posterior: Toric Design
Haptic Design Textured-rough haptic surface
Haptic Material Hydrophobic acrylic Vivinex™ with UV- and blue light filter
Dimension (Optic/OAL) 6.00 mm / 13.00 mm
Power +10.00 to +30.00 D (in 0.50 D increments)
Cylindrical Power 1.00 to 6.00 D (T2 to T9)
T2 to T3 in 0.50 D increments
T3 to T9 in 0.75 D increments
A-Constant 118.9
Optimized Optical constants

Haigis a0 = -0.278 a1 = 0.215 a2 =0.201
Hoffer Q pACD = 5.71
Holladay 1 sf = 1.94
SRK/T A = 119.2 (VivinexTM iSert® preloaded)

Front injector tip outer diameter 1.70 mm (Vivinex™ iSert® preloaded)
 
Available in Saudi Arabia, UAE, Oman, Qatar, Kuwait, and Lebanon. 
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Overview
HOYA VIVINEX™ MULTISERT™ (XC1-SP_XY1-SP)

Designed to provide outstanding optical quality, Vivinex™ offers clarity of vision for patients suffering from cataract. Vivinex™ is made from a novel glistening-free hydrophobic acrylic, using a proprietary manufacturing process that includes a unique, active oxygen posterior surface treatment [1,2,3]. This as well as its square edge design and one of the smoothest and most regular IOL surfaces has been shown to provide a low incidence of PCO in several studies [2,4,5,6,7,8,9,10].

 

multiSert™ provides unmatched control at the fingertips; it allows single-handed push and two-handed screw injection within one device. Has a uniquely designed adjustable insert shield for precise injector tip insertion depth management, allowing to insert the injector tip either directly into the capsular bag or through the incision wound tunnel. Moreover, multiSert™ provides outstandingly consistent and predictable IOL delivery [11].

 

Specifications

Model name

XC1-SP / XY1-SP

Optic material

Hydrophobic acrylic Vivinex™ with UV-Filter (Model XC1-SP) with UV- and blue light filter (Model XY1-SP)

Optic design

Aspheric Design with square, thin and textured optic edge

Haptic design

Textured-rough haptic surface

Haptic material

Hydrophobic acrylic Vivinex™ with UV-Filter (Model XC1-SP) with UV- and blue light filter (Model XY1-SP)

Diameter (optic/OAL)

6.00 mm / 13.00 mm

Power

+6.00 to +30.00 D (in 0.50 D increments)

Injector

multiSert™ preloaded

Front injector tip outer diameter

1.70mm

Recommended incision size

2.20mm

Nominal A-constant *

118.9

Optimized constants **

Haigis a0 = -0.8028 a1 = 0.2133 a2 = 0.2245
Hoffer Q pACD = 5.697
Holladay 1 sf = 1.934
SRK/T A = 119.198

* The A-constant is presented as a starting point for the lens power calculation. When calculating the exact lens power, it is recommended that calculations be performed individually, based on the equipment used and operating surgeon’s own experience

** These optimized constants for the calculation of intraocular lens power published by IOLCon on their website: https://iolcon.org are calculated from 1,475 clinical results for Vivinex™ model XY1/XC1 as of September 24, 2021. These constants are based on actual surgical data and are provided by IOLCon as a starting point for individual constant optimizations. The information available on the website is based on data originating from other users and not by HOYA Surgical Optics (“HSO”). HSO therefore does not warrant the correctness, completeness and currentness of the contents on the said website.

Some of the products and/or specific features may not be registered in your country and thus may not be available there.

 

References

1. Glistening-free per Miyata scale; study result of the The David J Apple International Laboratory for Ocular Pathology, University Hospital Heidelberg. Report on file.

2. HOYA data on file. DoF-CTM-21-002, HOYA Medical Singapore Pte. Ltd, 2021

3. Pérez-Merino, P.; Marcos, S. (2018): Effect of intraocular lens decentration on image quality tested in a custom model eye. In: Journal of cataract and refractive surgery 44 (7), p. 889–896

4. Leydolt, C. et al. (2020): Posterior capsule opacification with two hydrophobic acrylic intraocular lenses: 3-year results of a randomized trial. In: American journal of ophthalmology 217 (9), p. 224-231

5. Giacinto, C. et al. (2019): Surface properties of commercially available hydrophobic acrylic intraocular lenses: Comparative study. In: Journal of cataract and refractive surgery 45 (9), p. 1330–1334.

6. Werner, L. et al. (2019): Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. In: Journal of cataract and refractive surgery 45 (10), p. 1490–1497

7. Matsushima, H. et al. (2006): Active oxygen processing for acrylic intraocular lenses to prevent posterior capsule opacification. In: Journal of cataract and refractive surgery 32 (6), p. 1035–1040.

8. Farukhi, A. et al. (2015): Evaluation of uveal and capsule biocompatibility of a single-piece hydrophobic acrylic intraocular lens with ultraviolet-ozone treatment on the posterior surface. In: Journal of cataract and refractive surgery 41 (5), p. 1081–1087.

9. Eldred, J. et al. (2019): An In Vitro Human Lens Capsular Bag Model Adopting a Graded Culture Regime to Assess Putative Impact of IOLs on PCO Formation. In: Investigative ophthalmology & visual science 60(1), p. 113–122.

10. Nanavaty, M. et al. (2019): Edge profile of commercially available square-edged intraocular lenses: Part 2. In: Journal of cataract and refractive surgery 45 (6), p. 847–853

11. Usability and acceptability evaluation of the multiSert™ injector system, HOYA data on file DoF-SERT-102-MULT-03052018 (2018).

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Overview
HOYA VIVINEX™ TORIC MULTISERT™ (XY1A-SP)

Designed to provide precise astigmatism correction and clarity of vision for patients with an astigmatic cornea. Vivinex™ Toric IOL offers outstanding optical quality and rotational stability, delivered by multiSert™, providing unmatched control at your fingertips [3,10,11].

 

Vivinex™ Toric, made of a glistening-free hydrophobic acrylic IOL material [1,2] with proprietary aspheric optic design for improved image quality [3], allows active oxygen processing treatment, a smooth surface and square optic edge to reduce PCO [2,4,5,6,7,8,9,10], as well as Median rotation 1.1° [range: 0.0°–5.0°] 100% of lenses (n=103) had ≤5° of rotation from their initial axis at end of surgery through all follow up visits at 1 hour, 1 week, 1 month and 6 months [11].

 

Specifications

Model name

XY1A-SP

Optic design

Biconvex with square, thin and textured optic edge
Anterior: Aspheric design
Posterior: Toric design

Optic material

Hydrophobic acrylic Vivinex™ with UV- and blue light filter

Haptic design

Textured-rough haptic surface

Haptic material

Hydrophobic acrylic Vivinex™ with UV- and blue light filter

Diameter (optic/OAL)

6.00 mm / 13.00 mm

Power

+10.00 to +30.00 D (in 0.50 D increments)

Cylindrical Power

1.00 to 6.00 D (T2 to T9), T2 to T3 in 0.50 D increments, T3 to T9 in 0.75 D increments

Injector

multiSert™ preloaded

Front injector tip outer diameter

1.70mm

Recommended incision size

2.20mm

Nominal A-constant *

118.9

Optimized constants **

Haigis a0 = -0.8028 a1 = 0.2133 a2 = 0.2245
Hoffer Q pACD = 5.697
Holladay 1 sf = 1.934
SRK/T A = 119.198

 

Model XY1A-SP

Cylinder Power
at IOL Plane

Cylinder Power
at Corneal Plane***

T2

1.00 D

0.69 D

T3

1.50 D

1.04 D

T4

2.25 D

1.56 D

T5

3.00 D

2.08 D

T6

3.75 D

2.60 D

T7

4.50 D

3.12 D

T8

5.25 D

3.64 D

T9

6.00 D

4.17 D

* The A-constant is presented as a starting point for the lens power calculation. When calculating the exact lens power, it is recommended that calculations be performed individually, based on the equipment used and operating surgeon’s own experience.

** These optimized constants for the calculation of intraocular lens power published by IOLCon on their website: https://iolcon.org are calculated from 1,475 clinical results for Vivinex™ Model XY1/XC1 as of September  17, 2021. These constants are based on actual surgical data and are provided by IOLCon as a starting point for individual constant optimizations. The information available on the website is based on data originating from other users and not by HOYA Surgical Optics (“HSO”). HSO therefore does not warrant the correctness, completeness and currentness of the contents on the said website.

*** Based on an average pseudophakic human eye.

Some of the products and/or specific features may not be registered in your country and thus may not be available there.

 

References

1 Glistening-free  per  Miyata  scale;  study  result  of  the  David  J  Apple  International  Laboratory  for  Ocular  Pathology,  University  Hospital  Heidelberg.  Report  on  file.

2 HOYA  data  on  file.  DoF-CTM-21-002,  HOYA  Medical Singapore Pte. Ltd, 2021.

3 Pérez-Merino, P.; Marcos, S. (2018): Effect of intraocular lens decentration on image quality tested in a custom model eye. In: Journal of cataract and refractive surgery 44 (7), p. 889–896.

4 Leydolt, C. et al. (2020): Posterior capsule opacification with two hydrophobic acrylic intraocular lenses: 3-year results of a randomized trial. In: American journal of ophthalmology 217 (9), p. 224-231.

5 Giacinto, C. et al. (2019): Surface properties of commercially available hydrophobic acrylic intraocular lenses: Comparative study. In: Journal of cataract and refractive surgery 45 (9), p. 1330–1334.

6 Werner, L. et al. (2019): Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. In: Journal of cataract and refractive surgery 45 (10), p. 1490–1497.

7 Nanavaty, M. et al. (2019): Edge profile of commercially available square-edged intraocular lenses: Part 2. In: Journal of cataract and refractive surgery 45 (6), p. 847–853.

8 Matsushima, H. et al. (2006): Active oxygen processing for acrylic intraocular lenses to prevent posterior capsule opacification. In: Journal of cataract and refractive surgery 32 (6), p. 1035–1040.

9 Farukhi, A. et al. (2015): Evaluation of uveal and capsule biocompatibility of a single-piece hydrophobic acrylic intraocular lens with ultraviolet-ozone treatment on the posterior surface. In: Journal of cataract and refractive surgery 41 (5), p. 1081–1087.

10 Eldred, J. et al. (2019): An In Vitro Human Lens Capsular Bag Model Adopting a Graded Culture Regime to Assess Putative Impact of IOLs on PCO Formation. In: Investigative ophthalmology & visual science 60 (1), p. 113–122.

11 Schartmüller, D. et al. (2019): True rotational stability of a single-piece hydrophobic intraocular lens. In: The British journal of ophthalmology 103 (2), p. 186–190.

12 HOYA data on file. DoF-SERT-102-MULT-03052018, HOYA Medical Singapore Pte. Ltd, 2018 13 At IOL plane. 14 Based on an average pseudophakic human eye.

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Overview