SPS-402 IOL Design & Characteristics | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in this Session
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Posterior Capsule Opacification Prevention By an Intraocular Lens Incorporating a Micropatterned Membrane on the Posterior Surface
Authors
Sean J. Kennedy, MD
Vaishnavi Balendiran, MD
Liliana Werner, MD, PhD
Nathan C. Ellis, MD
Caleb L. Shumway, MD
Nick Mamalis, MD

Purpose
To evaluate the uveal biocompatibility and capsular bag opacification of a new hydrophobic acrylic microincision intraocular lens (IOL) that incorporates an active oxygen processing treatment (ultraviolet-ozone - UV-O3) in comparison to a commercially available single-piece hydrophobic acrylic lens in the rabbit model.

Methods
Eight New Zealand rabbits had bilateral phacoemulsification and implantation of the preloaded test lens (Nanex™, a 1-piece monofocal aspheric hydrophobic acrylic IOL with active oxygen processing on the posterior surface) through the multiSert+™ injector in one eye, and a commercially available preloaded lens (AcrySof™, also a 1-piece monofocal aspheric hydrophobic acrylic IOL) through the UltraSert™ injector model in the contralateral eye. Slit lamp examination was performed weekly for 4 weeks. The rabbits were then humanely euthanized and enucleated. Capsular bag opacification was assessed from the Miyake-Apple view, and the eyes underwent histopathologic evaluation.

Results
All surgical procedures were uneventful. Postoperative inflammatory reactions were not significantly different between test and control eyes. Mean postmortem central PCO was 0.93 ± 0.73 in the test group and 1.19 ± 0.53 in the control group. Peripheral PCO was 1.75 ± 0.92 in the test group and 2.06 ± 0.77 in the control group. Comparison of central and peripheral PCO between test and control groups did not yield any statistically significant difference (P = 0.41 and P = 0.35 respectively; two-tailed t-test paired two sample for means). Histopathologic examination did not show any significant difference in capsular bag opacification or untoward inflammation or toxicity in either group.

Conclusion
A new microincision IOL with a UV-ozone treatment performed similarly to a commercially available one-piece hydrophobic acrylic IOL in terms of uveal and capsular biocompatibility in the rabbit model. This is the first hydrophobic acrylic microincision IOL to demonstrate PCO performance similar to a conventional, commercially available IOL.
Comparison of Postoperative Shift between Different IOL Designs; Single, Double C-Loop Haptics in Bag, and Optic Captured Palate-Haptics
Authors
Takeshi Teshigawara, MD, PhD
Akira Meguro, PhD
Nobuhisa Mizuki, MD, PhD

Purpose
To compare postoperative intra ocular lens (IOL) shift between three IOL designs; singe C-loop (SN60WF : IQ) and double C-loop (Pod F : FineVision) acrylic IOLs in the bag and optic captured plate-haptic IOLs (FB313 MF15: FEMTIS). Correlation between the shift and preoperative biometric variables were investigated.

Methods
A randomized prospective study of 85 eyes (36 eyes in IQ, 35 eyes in FineVision and 14 eyes in FEMTIS). Anterior chamber depth (ACD), lens thickness (LT), and axial length (AL) were measured preoperatively. IQ and Fine Vision were placed in the bag and FEMTIS was placed in the optic capture using the reversed optic capture technique. Continuous curvilinear capsulorhexis (CCC) for the optic capture was created by femtosecond laser. At one day, one week, and one month, postoperative IOL position and ACD were measured using swept-source anterior segment optical coherence tomography. A postoperative IOL shift in the three types of IOLs was compared. Correlation of all variables was analyzed.

Results
One month postoperation, while IQ and FineVision showed forward shift by 0.179±0.134mm and 0.087±0.047mm respectively, FEMTIS demonstrated backward shift by 0.020±0.002mm; the difference in each shift was significant (P < 0.001). In IQ and FEMTIS, the more remarkable shift was seen between one day and one week postoperation. In IQ and FineVision, the forward shift showed a significant positive correlation with preoperative ACD and AL; Rho = 0.792 and 0.944 in IQ, Rho = 0.754 and 0.779 in FineVision (P < 0.001). This tendency was not seen with preoperative LT ; Rho = 0.122 in IQ and = -0.162 in FineVision. In FEMTIS, there was no significant correlation between IOL shift and each variable.

Conclusion
Optic captured plate-haptic IOLs were significantly more stable, followed by, double C- loop IOLs and then singe C-loop IOLs. This indicates that haptic design may affect stability of IOL position, and the optic capture placement can be more suitable than in the bag placement to improve the accuracy of prediction of post-operative refraction.
Incidence of Posterior Capsular Opacification and Lens Fibrosis in a Novel, Modular, Capsule-Filling Intraocular Lens
Authors
Uday Devgan, MD, ABO
Kerry K. Assil, MD
Sumit Garg, MD, ABO
Arturo S. Chayet, MD
Eric D. Donnenfeld, MD
Thomas Kohnen, MD, PhD
Rosa Braga-Mele, MD, FRCSC
Kerry D. Solomon, MD
Laura M. Fletcher, PhD
Enrique Barragán, MD

Purpose
To assess the long-term rates of posterior capsular opacification (PCO) and lens fibrosis in the Juvene® intraocular lens (JIOL; LensGen, Inc, Irvine, CA), from 6 to 54 months.

Methods
Patients underwent standard small-incision cataract phacoemulsification followed by implantation of a Juvene IOL. Twenty-six eyes were evaluated at 6 months, and 9 additional eyes were examined at time points between 30 and 54 months postoperatively. All eyes were dilated and retroilluminated slit lamp images were taken. PCO was subjectively graded by the surgeon at each of three sites. Surgeons also looked for evidence of lens fibrosis between the modular components of the JIOL or around the perimeter of the lens.

Results
All 35 eyes examined for PCO were graded as zero by the evaluating surgeon, indicating no evidence of opacification. Correspondingly, no Nd:YAG laser posterior capsulotomies were performed (or indicated) on any eyes. No evidence of lens fibrosis between lens components or around the perimeter of the lens was observed in any eye. All eyes retained their range of visual acuity at distance, intermediate, and near.

Conclusion
The modular, capsule-filling Juvene IOL seems to have significantly lower rates of PCO and lens fibrosis than other currently available IOLs while maintaining near vision over time.
Posterior Capsule Opacification and Biocompatibility of a New Microincision Intraocular Lens in Comparison to a Standard Lens
Authors
Sean J. Kennedy, MD
Vaishnavi Balendiran, MD
Liliana Werner, MD, PhD
Nathan C. Ellis, MD
Caleb L. Shumway, MD
Nick Mamalis, MD

Purpose
To evaluate the uveal biocompatibility and capsular bag opacification of a new hydrophobic acrylic microincision intraocular lens (IOL) that incorporates an active oxygen processing treatment (ultraviolet-ozone - UV-O3) in comparison to a commercially available single-piece hydrophobic acrylic lens in the rabbit model.

Methods
Eight New Zealand rabbits had bilateral phacoemulsification and implantation of the preloaded test lens (Nanex™, a 1-piece monofocal aspheric hydrophobic acrylic IOL with active oxygen processing on the posterior surface) through the multiSert+™ injector in one eye, and a commercially available preloaded lens (AcrySof™, also a 1-piece monofocal aspheric hydrophobic acrylic IOL) through the UltraSert™ injector model in the contralateral eye. Slit lamp examination was performed weekly for 4 weeks. The rabbits were then humanely euthanized and enucleated. Capsular bag opacification was assessed from the Miyake-Apple view, and the eyes underwent histopathologic evaluation.

Results
All surgical procedures were uneventful. Postoperative inflammatory reactions were not significantly different between test and control eyes. Mean postmortem central PCO was 0.93 ± 0.73 in the test group and 1.19 ± 0.53 in the control group. Peripheral PCO was 1.75 ± 0.92 in the test group and 2.06 ± 0.77 in the control group. Comparison of central and peripheral PCO between test and control groups did not yield any statistically significant difference (P = 0.41 and P = 0.35 respectively; two-tailed t-test paired two sample for means). Histopathologic examination did not show any significant difference in capsular bag opacification or untoward inflammation or toxicity in either group.

Conclusion
A new microincision IOL with a UV-ozone treatment performed similarly to a commercially available one-piece hydrophobic acrylic IOL in terms of uveal and capsular biocompatibility in the rabbit model. This is the first hydrophobic acrylic microincision IOL to demonstrate PCO performance similar to a conventional, commercially available IOL.
1-Month and 6-Month Rotational Stability of an Intraocular Lens Design with Modified Haptics
Authors
John A. Vukich, MD
Kevin L. Waltz, MD, OD
Benjamin Straker, BScOptom
D. Priya Janakiraman, OD
Pamela Smith, MPH

Methods
Methods A prospective, multicenter clinical study was conducted on a test IOL design featuring frosted haptic edges. Rotation data were compared to results for a control lens collected in a separate but similar protocol. The only difference between test and control lenses was that the haptic edges for the test lenses were frosted. Intraoperative photographs captured at the end of surgery were compared to slit lamp photographs taken at 1-day, 1-week, 1-month and 6-months postoperative to determine IOL rotation. Photographic analysis was completed by two independent analysts who were masked to reduce the risk of bias.

Results
At 1-month postoperative, data were available for 86 eyes and 114 eyes, and at 6-months postoperative, for 86 eyes and 103 eyes for test and control lenses, respectively. Mean absolute IOL rotation at 1-month was 0.87 ± 0.91° and 2.47 ± 3.31°, and at 6-months was 1.03 ± 1.09° and 2.53 ± 3.27° for test and control lenses, respectively. Consistent cohort data will also be presented. A statistically significant difference in mean absolute rotation favoring the frosted haptic lens was found at all postoperative time points (all p < 0.0001). For the test IOL, the percentage of eyes with >5° absolute rotation was 1.2% at 1 and 6 months, and no eyes had rotation >10° at any time point.

Conclusion
The intraocular lens design with frosted haptic edges demonstrated clinically acceptable rotational stability through 6-months postoperatively.
Depth of Focus Modeling of Aspheric IOLs Using Optical Raytracing
Authors
Eva I. Liang, MD, FACS, ABO
George M. Lau, OD
Valeri Kolesnitchenko, MD
Jihong Xie, PhD

Purpose
To compare depth of focus performance of two aspheric IOL designs using Optical Raytracing.

Methods
An optical raytracing model was created in Zemax OpticStudio® using an Liou and Brennan model eye with spherical aberration (SA) of 0.21µm at 5mm. A simulation was performed with different amounts of defocus (0.75D to +0.50D) introduced. The first type of IOL is designed to be free of SA (similar to MX60E IOL, Bausch and Lomb, Inc). The second IOL is designed to have negative SA (similar to SN60WF IOL, Alcon). Both subjective (image resolution) and objective (Modulation Transfer Function, MTF) were simulated to compare the depth of focus performance between the two types of aspheric IOL designs.

Results
The model eye with negative SA IOL showed slightly better contrast at emmetropic, in-focus state. The model eye with zero SA IOL showed a larger depth of focus with an increase of ~0.25D to 0.375D when compared to negative SA IOL. MTF through focus (TF) modelling with spatial frequencies of 50 lps/mm (VA: ~20/30) and 100 lps/mm (VA: ~20/20) showed broader TF curves for zero SA IOL compared to negative SA IOL.

Conclusion
The optical raytracing model demonstrated that an IOL with zero spherical aberration can increase depth of focus when compared to an IOL with negative spherical aberration. This occurs because of the residual uncorrected positive spherical aberration from the cornea.
Prospective Clinical Trial of a New Monofocal Intraocular Lens with Enhanced Depth of Focus
Authors
Jan Weindler, MD
Isabella D. Baur, MD
Piyanut Poompokawat, MD
Ramin Khoramnia, MD
Gerd U. Auffarth, MD, PhD

Purpose
To evaluate a new monofocal extended depth of focus IOL that meets ISO standards for a monofocal IOL, the xact Mono-EDOF ME4 from Santen.

Methods
So far 25 (42 eyes) patients have been recruited; mean age of patients is 71± 9.0 years. All patients underwent cataract surgery with implantation of the Mono EDOF ME4 intraocular lens mono- or bilateral. Postop follow-up examination after 1-month, 3-months and 8-months were performed including visual acuity testing, defocus curve, contrast sensitivity and halo&glare evaluation.

Results
So far 42 intraocular Mono-EDOF lenses have been implanted ranging from +18 to +28 diopters. The 8-months postop follow-up reviewed a good uncorrected far and intermediate visual acuity, around 0.1 LogMAR. Contrast vision showed a slight reduction. The photopsia evaluation shows almost no impairments. Patient’s feedback was very positive.

Conclusion
The preliminary 8-months results of the new mono-EDOF technology show a good far and intermediate visual acuity as well as a functional near visual acuity with nearly no impairment by photopsia.
Ray-Tracing Analysis of Depth-of-Focus and Optical Properties of Aspheric IOLs
Authors
Larissa Gouvea, MD
Jorge S. Haddad, MD
Muhanned Al Windi, MD
George O. Waring IV, MD, FACS
Karolinne M. Rocha, MD, PhD, ABO

Purpose
To evaluate subjective depth of focus (DoF) curves and static and dynamic factors that influence pseudoaccommodation in aspheric intraocular lenses (IOLs) in normal and hyperprolate corneas using Scheimpflug tomography and ray-tracing aberrometry.

Methods
Ray-tracing aberrometry was used to objectively measure DoF in normal and hyperprolate corneas implanted with an aberration-free IOL (Mx60E, Bausch&Lomb), and in normal eyes implanted with a negative spherical aberration IOL (ZCBOO, J&J) at 1-3 months postoperatively. Scheimpflug tomography and ray-tracing aberrometry static and dynamic metrics were analyzed, including lower and higher-order aberrations, Visual Strehl of the Optical Transfer Function (VSOTF), Extended Range of Focus (EROF), pseudoaccommodation and accommodation range index (sphere shift).

Results
64 eyes were included in this study. The hyperprolate cornea group implanted with an aberration free IOL had statistically significant better DCNVA at 33cm (p<0.01) and higher visual acuity over a defocus range of +2.50 to -4.00D. In normal eyes, DCNVA at 33cm was 0.42 0.17 logMAr for the aberration free IOL group and 0.500.27 logMAR for the negative spherical IOL (p=0.11). Ray-tracing analysis showed no statistically significant difference in EROF, pseudoaccommodation, or sphere shift (p>0.05) among the groups. Scheimpflug tomography displayed more negative SA (p<0.01), coma (p=0.01) and total HOAs (p<0.01) in the hyperprolate cornea group compared to normal corneas.

Conclusion
Pseudoaccommodation from changes in spherical aberration and residual higher-order aberrations may improve near vision acuity in pseudophakic eyes. Aberration free IOL behaved as an EDOF IOL in patients with hyperprolate corneas.
Description of a Retrospective Study Using EHR-Based Registry to Correlate IOL Biocompatibility with Time to PCO Diagnosis
Authors
Bret L. Fisher, MD, ABO
Xiaolin Gu, MD, PhD
Mohinder Merchea, OD, PhD

Purpose
To describe a study using AAO’s IRIS® Registry to correlate IOL material biocompatibility with time to PCO diagnosis.

Methods
Using data from the IRIS Registry between January 1st, 2016 to March 31, 2018, a cohort of eyes implanted with either of two hydrophobic acrylic IOLs of interest after cataract surgery was assembled. The analysis was limited to practices which provided data for ≥ 1 years after surgery. The primary analysis calculated mean time to PCO diagnosis by IOL types (monofocal, toric, multifocal or EDOF IOL) and material (AcrySof or Tecnis hydrophobic acrylic) in eyes which met inclusion/exclusion criteria. Patient demographics were also reported.

Results
In the cohort of 89947 eyes implanted with AcrySof (A) or Tecnis (T) IOLs which met inclusion/exclusion criteria, 43023 eyes (47.8%) completed 2 year follow-up. Among them, 35.7% had PCO diagnosis with overall mean (SD) time to PCO diagnosis at 268.4 (±194.5) days. Multifocal/EDOF IOL-implanted eyes, regardless of brands, had shorter mean Tdx compared to monofocal-implanted eyes (P<0.0001). Age, sex and race adjusted mean Monofocal Tdx was 300 days for A vs 269 days for T (P<0.0001). Among MF/EDOF implanted eyes, mean Tdx was 250.6 days for A MFIOL vs 196.3 days for T MFIOL(P<0.0001) and 213.9 days for T EDOF (P<0.001), suggesting AcrySof IOLs are more resistant to PCO formation.

Conclusion
Retrospective studies using comprehensive clinical databases IRIS Registry is able to generate real-world evidence to answer clinically important questions. Earlier PCO diagnosis was observed in Multifocal or EDOF IOL implanted eyes compared to monofocal IOL implanted eyes. Biomaterial has an impact on time to PCO diagnosis.

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