SPS-313 Presbyopia-correcting IOLs II | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in this Session
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Small Aperture Intraocular Lens in Cataract Patients: Multicentre Experience in Australia
Author
Brendan J. Vote, MBBS

Purpose
To evaluate the ability of the IC-8 intraocular lens to achieve extended depth of focus post cataract surgery.

Methods
A multicentre, non-randomised, retrospective case series. Data was collected and pooled from six centres across Australia with 109 consecutive patients implanted with the IC-8 IOL. Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) at 80 cm and uncorrected near visual acuity (UNVA) at 40 cm were measured. Adverse events, spectacle independence, visual symptoms and patient satisfaction were assessed.

Results
Over 90% of the patients without pre-existing ocular pathology (n = 109) achieved UDVA, UIVA and UNVA of 6/12 or better in the IC-8 eye. Binocularly, in this group, 98% achieved UDVA of 6/9, 94% UIVA of 6/12 and 91% UNVA of 6/12 or better. Some patients experienced mild to moderate symptoms that resolved during the post-operative period. By final follow-up over 50% of patients reported complete spectacle independence for distance, intermediate and near visual activity with the remainder only using spectacles for specific tasks such as near vision hobbies and reading in dim light.

Conclusion
The IC-8 IOL is capable of achieving extended depth of focus and spectacle independence following cataract surgery.
Study Results from All 18 Investigational Sites Including Logmar Vas, Contrast Sensitivity & PRO Results for a New Segmented Multifocal IOL.
Authors
Jeffrey Whitsett, MD
Y. Ralph Chu, MD

Purpose
To evaluate the Overall Study clinical results following implantation of a new segmented multifocal IOL design in an FDA IDE clinical trial

Methods
The study is designed to compare bilateral implantation results of the SBL-3 multifocal IOL (Lenstec Inc.) to that of the control group. This paper will include the All Implanted dataset for all (18) Investigational study sites. Subjects are enrolled in a prospective, randomized and parallel manner and are evaluated up to 1 year post-operative. Adverse reactions and several visual acuity outcomes are measured. Subjective patient outcomes are also collected.

Results
Distance corrected near vision in the primary eye was 0.109 LogMar (~20/25) while the control was 0.569 LogMar (~20/63) (p<0.0001). Distance corrected intermediate vision in the primary eye was 0.120 LogMar (~20/25) while the control was 0.301 LogMar (~20/40) (p<0.0001). Best corrected distance vision in the primary eye was 0.003 LogMar (~20/20) while the control was -0.039 LogMar (~20/20) (p=0.745). Cystoid macular edema occurred in both groups, with a greater proportion in the control group. There was one pupillary block and one retinal detachment in the SBL-3 group. There were three secondary surgical interventions required in the SBL-3 group versus zero for the control.

Conclusion
The SBL-3 IOL provides equivalent distance vision and excellent intermediate and near vision compared to the control. Adverse events were minimal and expected. Patients receiving the SBL-3 were very satisfied with their vision.
To Evaluate of a Small Aperture Intraocular Lens As a Mix & Match Combination with a Rotational Asymmetric Edof Intraocular Lens.
Authors
Florian T. Kretz, MD
Detlev R. Breyer, MD
Gerd U. Auffarth, MD, PhD
Ramin Khoramnia, MD

Purpose
Evaluation of the functional results after Mix & Match implantation of an asymmetric multifocal lens in the distant dominant eye and a small aperture IOL in the partner eye.

Methods
In 11 patients the multifocal IOL Lentis LS-313 MF20 (Oculentis, target refraction: plan) was implanted in the distant dominant eye and the small aperture IOL IC-8 (Acufocus, target refraction: -0.75 dpt) in the near dominant eye. After 3 and 6 months the visual acuity [UDVA, CDVA] was measured, the defocus curve was performed, the optical imaging quality was determined with the HD Analyzer and photopic phenomena were evaluated with the Halo & Glare Simulator. The near and intermediate range was measured with the Salzburg Reading Desk.

Results
The IC-8 eyes showed a cumulative spherical equivalent of -0.48 dpt [+/- 0.36]. The average UCVA was 0.11 logMAR [+/-0.15] and the CDVA 0.07 logMAR [+/- 0.12]. The MF20 eyes show a cumulative spherical equivalent of -0.2 dpt [+/-0.33]. The UCVA has an average value of 0.17 [+/-0.18] logMAR and the CDVA has an average value of 0.09 [+/-0.17] logMAR. The binocular results are as follows: The UCVA is 0.08 [+/- 0.15] logMAR, the BCVA 0.02 [+/- 0.14] logMAR. The binocular defocus curve shows a logMAR visual acuity also <0.2 over a range from -3.0 dpt to +1.50 dpt. When interviewed for halo and glare, 4 patients stated that they would not perceive any light phenomena.

Conclusion
The Mix & Match combination of MF20 and IC-8 shows a good distance visual acuity. The defocus curve is similar in the monocular and binocular comparison. A possible restriction of the visual field and the restricted view of the ocular fundus must be viewed critically.
Quality of Vision at Six Months with a Modular, Non-Light-Splitting, Presbyopia-Correcting Intraocular Lens.
Authors
Sumit Garg, MD, ABO
Rosa Braga-Mele, MD, FRCSC
Kerry K. Assil, MD
Laura M. Fletcher, PhD

Purpose
To comprehensively evaluate quality of vision in patients implanted with the a modular, non-light-splitting, presbyopia-correcting intraocular lens.

Methods
Twenty-six eyes underwent standard cataract phacoemulsification followed by implantation of the Juvene IOL (JIOL; LensGen, Inc, Irvine, CA). Mesopic (3 cd/m2) contrast sensitivity for sine wave gratings was measured using a computerized system (M&S Technologies®)) at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd); sensitivity was measured with and without glare. Eleven patients with bilateral implantation of the JIOL completed the McAlinden quality of vision (QoV) questionnaire at 1, 3, and 6 months postoperatively.

Results
Mean contrast sensitivity for patients with the JIOL was not significantly different from the normative data for the M&S system (which was collected on a younger, healthy population) except at the highest spatial frequency measured (12cpd). This was true for both conditions (with and without glare). All bilateral patients are spectacle free and have no reported dysphotopsia.

Conclusion
Contrast sensitivity paired with subjective visual experience of dysphotopsia gives insight into a patient’s quality of vision for everyday tasks. Patients implanted with the JIOL experience no dysphotopsia and have contrast sensitivity that is similar to patients who are on average two decades younger measured with the same computerized system.
Clinical Study Results of a New Segmented Multifocal IOL: Overall Results from All 18 Investigational Sites for "Quality" of Vision Only.
Author
James C. Loden, MD

Purpose
To evaluate the Overall Study quality of vision to encompass contrast sensitivity and PRO results following implantation of a new segmented multifocal IOL design in an FDA IDE clinical trial

Methods
The study is designed to compare bilateral implantation results of the SBL-3 multifocal IOL (Lenstec Inc.) to that of the control group. Subjects are enrolled in a prospective, randomized (2:1 randomization plan) and parallel manner and were evaluated up to 1 year post-operative. This paper will include the overall study results from all 18 investigational sites for quality of vision only but will include contrast sensitivity and PRO results. Adverse reactions and several visual acuity outcomes were measured as well as contrast sensitivity. Subjective patient outcomes were (in the form of a Patient Reported Outcomes) questionnaire also collected.

Results
Binocular Contrast Sensitivity under photopic and mesopic conditions, with and without glare showed the mean difference of the SBL-3 and the control at all measured cpd. These were: Photopic without glare 0.181: with glare, 0.170: Mesopic without glare, 0.181 and with glare, 0.144 (p-<0.0001). The mean total visual disturbance score for the SBL-3 was 2.15 and control 1.75 (p=0.0342), on a scale of 0 to 10. The mean total spectacle independence score for the SBL-3 was 1.28 and control 2.78 (p-<0.0001). On a scale of 1 to 5, the likelihood to choose the same lens again score was 4.16 and 3.66 for the SBL-3 and control, respectively, (p-<0.0001).

Conclusion
The SBL-3 provided good contrast sensitivity which was not clinically different than that of the control. Patient satisfaction and spectacle independence was superior compared to the control lens.
Six Months Visual Acuity Results after Implantation of a New Modular, Curvature-Changing, Fluid-Optic Intraocular Lens
Authors
Eric D. Donnenfeld, MD
Uday Devgan, MD, ABO
Arturo S. Chayet, MD
Thomas Kohnen, MD, PhD
Rosa Braga-Mele, MD, FRCSC
Kerry K. Assil, MD
Sumit Garg, MD, ABO
Kerry D. Solomon, MD
Enrique Barragán, MD

Purpose
To asses 6-month visual outcomes of eyes implanted with the Juvene® intraocular lens (JIOL; LensGen, Inc, Irvine, CA), a unique, modular, curvature-changing, fluid-optics intraocular lens (IOL).

Methods
Patients underwent standard small-incision cataract phacoemulsification followed by implantation of a Juvene IOL. The Juvene IOL consists of 2 components, a base lens that fills the capsular bag and a curvature-changing fluid-optic that fits into the base lens and provides incremental refractive power for a continuous range of vision, distance to near. Postoperative vision measures include corrected distance visual acuities (CDVA), distance-corrected intermediate and near visual acuities (DCIVA, and DCNVA), and defocus curves.

Results
Twenty-six eyes were implanted with the Juvene IOL and assessed 6 months postoperatively. Mean monocular BCDVA was logMAR 0.00 (20/20). Mean DCIVA and DCNVA was 0.10 (20/25) at intermediate and 0.24 (20/32-2) at near distances. Defocus curves for the Juvene IOL showed improved VA compared to monofocal or extended depth-of-focus IOLs. There were no surgical or postoperative complications related to the lens.

Conclusion
These results suggest the biomimetic Juvene IOL provides a successful range of vision from distance through near for patients made aphakic after cataract surgery
LONG-TERM Clinical Experience with Multifocal Segmented BI-Aspheric LENS with 400 Eyes on File
Authors
Jeffrey Whitsett, MD
Andrea Janekova, MD

Purpose
To evaluate efficacy, predictability, safety and subjective outcomes of rotationally asymmetric multifocal segmented bi-aspheric intraocular lens in patients with cataract and clear lens extraction.

Methods
A prospective study based on evaluation of 400 eyes of 204 patients. Patients with ophthalmic pathology which would affect the quality of postoperative vision were not included. Corneal astigmatism from 1D to 1.5D was treated by LRI. Patients with higher astigmatism were excluded. The SBL-3 is a hydrophilic acrylic presbyopia correcting lens. The IOL power was calculated using SRK/T formula. Patients were evaluated 4 years (±4 months) postoperatively for distance, intermediate (70cm) and near (40cm) visual acuity and monocular and binocular defocus curve examination was performed. A satisfaction questionnaire about photopic phenomena and evaluation of spectacle independence was completed.

Results
Monocular UCDVA was 0.8 (decimal) or better in 94% of eyes, and 1.0 or better in 83% of eyes. Monocular UCIVA was 0.8 or better in 86% of eyes, and 1.0 or better in 40% of eyes. Monocular UCNVA was 0.8 or better in 94% of eyes and 1.0 or better in 62% of eyes. The photopic monocular defocus curve 4 years (±4 months) postoperatively shows continuous range of vision (visual acuity above 0,2 logMAR) up to -3D which corresponds to distance to 33cm. Thirty one percent of patients underwent Nd:YAG capsulotomy for posterior capsule opacification. Subjectively patients report low levels of photopic phenomena and high levels of spectacle independence in everyday activities for all distances.

Conclusion
SBL-3 patients report excellent visual outcomes and low levels of photopic phenomena. Patients receiving SBL-3 attained very good uncorrected visual acuity at all range of distances and gained spectacle independence. Also, preoperatively myopic patients that used to read without spectacles were very satisfied with the near vision after surgery.
FDA Ide Clinical Study Results of a New Multifocal (segmented) IOL Design: Individual Clinical Study Site Data of Jeffrey C. Whitsett, M.D.
Author
Jeffrey Whitsett, MD

Purpose
To evaluate an individual study site's clinical results following implantation of a new segmented multifocal IOL design in an FDA IDE clinical trial

Methods
The study is designed to compare bilateral implantation results of the SBL-3 multifocal IOL (Lenstec Inc.) to that of the control group. Subjects are enrolled in a prospective, randomized and parallel manner and are evaluated up to 1 year post-operative. Adverse reactions and several visual acuity outcomes are measured. Subjective patient outcomes are also collected.

Results
Individual site data: Mean age 69.9 (SBL-3), 69.3 (control)p= 0.7319. 75% female (SBL-3), 63.6% female (control). Primary eye LogMar visual acuity means at one year post- operative results. BCDVA of -0.042 (SBL-3 IOL), -0.079 (control) 90% CI: 0.002,0.072; DCNVA of 0.058 (SBL-3), 0.486 (control) 90% CI: -0.481,-0.377; DCIVA of 0.001 (SBL-3), 0.236 (control) 90% CI: -0.281,-0.189. Defocus Curve Means will be presented for a range of -0.5.0 D through + 2.0 D in half-diopter increments. Spectacle Independence rates for near, intermediate and distance will also be presented along with visual disturbances means and patient satisfaction. No Serious Adverse Events were reported at this site.

Conclusion
The SBL-3 IOL provides exceptional near and intermediate vision while maintaining comparable distance vision when compared to a monofocal control. The patient reported outcomes survey showed higher levels of spectacle independence and patient satisfaction while maintaining a non-clinical difference in visual disturbances.
Visual Outcomes, Reading Speed & Spectacle Independence in Patients Implanted with an Edof IOL Combined with a Low Add Multifocal IOL
Authors
Helga P. Sandoval, MD, MSc
Richard Potvin, OD
Kerry D. Solomon, MD

Purpose
To evaluate visual outcomes, reading speed & spectacle independence in patients implanted with an extended depth of focus (EDOF) IOL combined with a multifocal IOL with a +3.25D add, and compare it to a historical control of eyes with bilateral EDOF targeted for emmetropia (EM) OU or nanovision (NV) (dominant eye: plano & non-dominant eye: -0.50 D)

Methods
Prospective, single center, non-randomized study that included 39 patients undergoing bilateral cataract surgery with implantation of an EDOF IOL and a multifocal IOL +3.25 D Add in the dominant and non-dominant eye, respectively (Personalized Vision, PV). Both eyes target refraction was plano (±0.25 D). ETDRS uncorrected (4m, 66, 40 cm and near best distance), best distance corrected (4m) and distance-corrected (66, 40 cm and near best distance) visual acuities and reading speed were evaluated 3 months after surgery. Statistical analysis comparing the three groups were done. A P-value < .05 was considered significant.

Results
Data from 32 PV, 29 EM and 25 NV subjects was available for analysis. No significant differences in UCVA by group at 4m or 66cm. UNCVA (40cm) was significantly better in the PV group (P < .001), but not different between EM and NV groups. PV group had about 1 line better near VA. DCVA at 66 cm was significantly better in the PV group than the EM. DCVA at 40cm was significantly better in the PV (P < .001) compared to the other two groups. Best reading distance was 40cm for the EM and NV groups and 38cm for the PV group. No significant differences in reading speed at any logRAD value. Overall, 94% (PV) and 92% (NV) reported wearing glasses little or none of the time vs 68% in the EM group.

Conclusion
Uncorrected and distance-corrected near VA in the personalized vision group was about 1 line and 2 lines better than that obtained with a nanovision approach and bilateral Emmetropia OU, respectively. Uncorrected distance VA was similar between groups. No difference in reading speed between the groups. Spectacle independence similar in PV and NV.
Stability of Lens Position, Rotation, and Refraction with a Modular, Capsule-Filling, Presbyopia-Correcting Intraocular Lens.
Authors
Rosa Braga-Mele, MD, FRCSC
Sumit Garg, MD, ABO
Uday Devgan, MD, ABO
Eric D. Donnenfeld, MD
Arturo S. Chayet, MD
Thomas Kohnen, MD, PhD
Kerry D. Solomon, MD
Kerry K. Assil, MD
Laura M. Fletcher, PhD

Purpose
To assess the stability of the Juvene® intraocular lens (JIOL; LensGen, Inc, Irvine, CA), a unique, modular, curvature-changing, fluid-optics intraocular lens six months after implantation.

Methods
Twenty-six eyes underwent standard cataract phacoemulsification followed by implantation of the JIOL. Effective lens position (ELP) was assessed by measuring anterior chamber depth (ACD) using ultrasound biomicroscopy (UBM) at one, three, and six months postoperatively. Rotation of the IOL was assessed in 12 of those patients implanted with JIOL with orientation markings. Retro-illuminated slit lamp images were taken at 1, 3 and 6 months and compared to video frames taken from the surgical video. Degrees of rotation from baseline was measured using IC Measure (The Imaging Source®). Refractive stability of the JIOL was measured by vector analysis between time points for each patient.

Results
A paired samples t-test comparing ACD at 6 months to ACD at 1 month was not significant (t = 1.79, p > 0.05); the average amount of movement was 0.03 (SD = 0.09) mm, indicating that the lens is remaining in position. Mean IOL rotation was 1.7 degrees (SD = 0.09 degrees). 100% of IOLs rotated less than 5 degrees. After 6 months, 94% of patients had a refractive change of ≤ 0.5 diopters.

Conclusion
These results indicate that the Juvene IOL remains highly stable over time with regards to ELP, rotation, and refraction.
Optical-Quality Comparison of a Small Aperture IOL with a Diffractive Extended-Depth-of-Focus and a Standard Monofocal Lens
Authors
Grzegorz Labuz, PhD
Ramin Khoramnia, MD
Hyeck-Soo Son, MD
Gerd U. Auffarth, MD, PhD

Purpose
The IC-8 (AcuFocus) is a recently introduced IOL that uses a small-aperture principle to extend the depth of focus. This pinhole IOL aims to provide an excellent distance vision that one expects of monofocal lenses. The purpose of this study was to evaluate the image quality of the IC-8 and compare it with a diffractive EDoF and a monofocal IOL.

Methods
An optical-bench setup was used to study image-quality metrics of the pinhole IOL, a diffractive EDOF (Symfony, J&J), and a standard monofocal (SA60AT, Alcon) lens. The IOLs’ modulation transfer function (MTF) was measured in an aberrated model eye with polychromatic light and a 3-mm artificial pupil. A -0.75D refraction target was simulated for the IC-8 and plano for the other IOLs. The MTF area was calculated, and the lens performance was compared at a range of defocus values. IOLs’ tolerance to misalignment was assessed up to 0.75 mm of decentration.

Results
The MTF analysis showed one extended focus area centered at -0.75D, but the Symfony demonstrated two peaks at zero and 1.75D, with the minimum occurring at (approx.) 1D. Despite the myopic target, the pinhole lens had a comparable MTF as the monofocal lens at the far focus, and a higher MTF area than the diffractive IOL by 24%. At the intermediate range (1.75D), the Symfony and the pinhole lens performed similarly and were superior to the SA60AT in terms of defocus tolerance. The optical quality of the monofocal lens virtually did not change with decentration, but it affected the performance of the two EDoF IOLs.

Conclusion
We demonstrated that the small-aperture lens provides an EDoF effect that is comparable to that of the Symfony and has a similar image quality as the monofocal lens at distance. A slight myopic target of -0.75D increases the range of intermediate and near focus in patients with the pinhole IOL.
First Results of Implantation of the Small-Aperture Intraocular Lens Binocularly
Author
Magda B. Rau, MD

Purpose
To evaluate optical and functional outcomes and patients satisfaction after Implantation of a Small-Aperture IC-8 IOL Intraocular Lens binocularly.

Methods
In a prospective case study from September 2018-January 2019 a series of 10 patients, presenting for cataract surgery, were implanted bilaterally with a single-piece hydrophobic acrylic intraocular with a centrally located opaque annular mask measuring 3.23 mm in total diameter with a 1.36 mm central aperture. The visual acuity for distance, intermediate and near vision was evaluated. The quality of vision, glare, halos and the personal satisfaction of the patients was assessed with a validated questionnaire.

Results
Three months after the Implantation the mean UCVA for distance was monocular 0,78, binocular 0,89 for intermediate monocular 071, binocular 0,76,for near vision monocular 0,58, binocular 0,63. The mean refraction was -0,35D None of the patients needed glasses for working on PC , 76 % were able to read newspaper without glasses. The questionnaire showed, that 30% of the patients were very satisfied and 70% satisfied with the achieved results, nobody complained about halos and glares.

Conclusion
Early optical and functional results from patients implanted with this novel IOL implanted bilateral show, that IC 8 implanted bilateral provides an excellent visual acuity for distance, intermediate and very good near vision. Overall patient satisfaction was high.
Pinhole Intraocular Lens to Correct Presbyopia and Astigmatism in Eye with Regular and Irregular Cornea : Four Year Follow up
Authors
Matteo Piovella, MD
Barbara Kusa, MD

Purpose
To demonstrate visual performance of the IC-8 small aperture IOL (AcuFocus, Irvine, CA) implanted in patients in whom a cataractous lens has been removed. Pinhole IOLs technology demonstrated to be the best available technology to be implanted in patients that have experienced previous RK or with irregular corneal astigmatism

Methods
21 Eyes with cataract, corneal astigmatism ≤ 1.25,had IC-8 IOL implantation in the non-dominant eye and a monofocal IOL in the dominant eye.Postoperatively,visual and refractive parameters were measured:distance(4m)near(40cm)and intermediate(80 cm)visual acuity, corneal topography and Acutarget analysis, contrast sensitivity and defocus curve. Follow-up examinations were performed up to 4 years.

Results
Pinhole effect was well known since Egyptian first dynasty. It is surprising as a simple optical concept create efficient benefits for cataract patients to overcome presbyopia weak points and to make easy astigmatism management without depending by the high tech toric lens management. The IC8 musk decreases halos and glare in aberrate cornea At 4 years in the IC-8 eye,UDVA is 20/20.5,UIVA is 20/19 at 80cm and 67 cm and UNVA is 20/20.5.In the monofocal eye,UDVA is 20/19,UIVA is 20/23 at 80cm 20/25.7 at 67cm and UNVA is 20/50.Binocular UDVA is 20/18,UIVA is 20/18.3(80 cm and 67cm)and UNVA is 20/20.5

Conclusion
Small aperture IOL provides near vision and astigmatism correction up to 2 D also if implanted only in the non dominant eye. Pinhole effect is not distance monovision because minimum far vision with IC8 was 20/25 Pinhole effect normally corrects up to two diopters of corneal astigmatism and overcome toric IOL management within this range

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