SPS-212 Extended Depth of Focus & Extended Range of Vision IOLs | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in this Session
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Defocus Curve, Visual Disturbances and Patient Satisfaction after Implantation of an Edof IOL Combined with a Multifocal +3.25D Add IOL
Authors
Helga P. Sandoval, MD, MSc
Richard Potvin, OD
Kerry D. Solomon, MD

Purpose
To evaluate the defocus curve, visual disturbances and satisfaction in patients implanted with an extended depth of focus (EDOF) IOL combined with a multifocal +3.25 D Add and compare it to a historical control of eyes implanted bilaterally with EDOF target plano OU (EM) or when the non-dominant eye is targeted for -0.50 D (Nanovision, NV).

Methods
Prospective, single center, non-randomized study that includes 39 patients undergoing bilateral cataract surgery with implantation of an EDOF IOL in the dominant eye and a multifocal IOL +3.25 D Add in the non-dominant eye (Personalized Vision, PV). Binocular defocus curve from -5.00D to +2.00D in 0.5 D steps as well as visual disturbances and patient satisfaction are evaluated at 3 months postoperatively. Statistical analysis comparing the three groups is done. A P-value < .05 is considered significant.

Results
Results will be updated. Preliminary results included 32, 25 and 29 patients in the PV, EM and NV groups, respectively. No difference in the binocular defocus curve between the 3 groups at any of the test vergences from +0.50D to -0.50D. Statistically significant differences at -1.00D PV v. NV, -1.50D PV v. EM and -2.00D to -3.50D PV v. NV and EM. The defocus curve difference at -2.5D between PV and NV was about 2 lines of acuity and 2.5 lines with EM. A higher percentage of patients in the PV reported visual disturbances compared to the EM and NV groups. Overall, 100% in PV were satisfied or mostly satisfied compare to 88% in NV and 93% in the EM.

Conclusion
Preliminary results show better near visual acuity and high patient satisfaction in the personalized vision group compared to Emmetropia and Nanovision, although the PV group reported more visual disturbances.
Visual Outcomes of a Next-Generation Hydrophobic Single-Piece Acrylic Extended-Depth-of-Focus and a Monofocal Intraocular Lens
Authors
Jason J. Jones, MD
Nia Thomas, OD
D. Priya Janakiraman, OD

Purpose
To evaluate depth of focus and visual acuity outcomes between an investigational next-generation extended depth-of-focus intraocular lens (EDOF IOL) and the TECNIS monofocal IOL Model ZCB00.

Methods
This was a prospective, bilateral, multi-center, six-month clinical trial (US). Cataractous adults with < 1.0 D of corneal astigmatism in both eyes were randomized to investigational (test) IOL or monofocal (control) IOL and targeted for emmetropia. Key postoperative endpoints included mean monocular and binocular distance-corrected depth of focus at 6 months (defined as diopters of negative defocus with at least 0.2 logMAR visual acuity). Additional endpoints were mean monocular best-corrected distance visual acuity (BCDVA) and proportion of subjects achieving a 0.2 logMAR monocular distance-corrected visual acuity at 66 cm (DCIVA) and 40 cm (DCNVA), and rates of significant dysphotopsia.

Results
Data from 217 subjects were available at six months (test n=110, control n=107). The test IOL demonstrated both an increased mean monocular (first eye) and binocular depth of focus by approximately 1.5 D at a visual acuity of 0.2 logMAR vs. the control IOL and maintained 0.2 logMAR acuity through approximately 2.5 D of defocus. There was a three-fold increase in the percent of test over control subjects who achieved monocular DCIVA of 0.2 logMAR (20/32) or better and a four fold increase in DCNVA over control. No clinical difference in mean monocular BCDVA was found between groups. In addition, overall rates of severe halos, starbursts, and glare were less than 4% in each group.

Conclusion
The next-generation EDOF IOL demonstrated exceptional visual performance from distance to near (better than control) and a favorable dysphotopsia profile for a presbyopia-correcting IOL. The next-generation EDOF IOL provided a substantial benefit over control with an extended depth of focus range that enables improved near vision for patients.
Comparative Analysis of Visual Outcomes, of a New Non-Diffractive Extended Vision Intraocular Lens in Indian Population
Authors
Birendra Prasad Kashyap, MS
Bharti Kashyap, MS
Nidhi Gadkar, MS, DNB
Kashyap Bibhuti, MD, DNB

Purpose
To Present Clinical Data of Distance ,Intermediate & near visual outcomes ,contrast Sensitivity, defocus curve, Photic Phenomena after Implantation of a new non-diffractive Extended Vision intraocular lens (Tecnis eyhance ICBOO IOL),in comparison with the Standard Monofocal IOL (Tecnis ZCBOO) IOL in Indian Population

Methods
This prospective , non randomized and comparative Study included 100 patients scheduled to undergo cataract surgery with bilateral implantation of two monofocal IOLS Gr-1 New monofocal IOLs (100eyes) Tecnis Eyhance ICBOO & Gr-2 Standard monofocal IOLs (100eyes) (Tecnis ZCBOO) Binocular Un corrected Distance (UDVA), Intermediate (UIVA)66cm & near (UNVA) 40cm visual acuities , .Photopic & Mesopic contrast sensitivity, Dysphotopsia profile Halos ,glare & Starbursts(QoV,McAlinden), defocus curve & Spectacles dependence questionnaires were assessed at 90 post operative days after 2nd eye IOL implantation.

Results
UDVA Mean±SD 0.09±0.12 & 0.04±0.50 for Gr-1&Gr-2,Non sig p=0.283,95%CI =0.01,0.08, UIVA Mean±SD 0.25±0.54 & 0.50±0.21 for Gr-1 & Gr-2,Sig (p=0.000),95% CI-.32,-.19,UNVA Mean±SD 0.45±0.20 ,0.51±0.13 for Gr-1 & Gr-2, Non Sig p value=0.06, 95% CI-.14..003.Photopic CS Non sig 5CPD (Diff=-.01, p= 0.62, 95%CI=-0.01,.0167 10CPD (p=0.86 ,95%CI=-0.016,0.019),For 15 CPD (p=0.69,95%CI=-0.014,0.021)-90 days ,Mesopic CS Non sig between GR-I & Gr-2 at 5CPD p=0.66,95%CI=-0.014,0.022,10CPD(p=0.72,95%CI=- 0.014,0.020) &15 CPD(P=0.59,95%CI=-0.026,0.046)-90 days. Defocus Curve sig better in Gr-1 at 1.00D,1.50D&2.00D p<.05 Intermediate Spectacles independence sig better Gr-1 P=0.00,Dysphotopsia are Comparable

Conclusion
Bilateral implantation of non-diffractive extended vision IOL provided extended range vision,while maintaining low incidence of unwanted photic phenomena.Eyhance ICBOO IOLs specially beneficial to self driving computer working Indian population as well for shopping time label reading,seeing uneven surfaces while walking
Predictors of Patient Satisfaction after Refractive Lens Exchange with an Extended Depth of Focus IOL
Authors
Julie Schallhorn, MD
Steven C. Schallhorn, MD, ABO
Stephen J. Hannan, OD

Purpose
To identify the independent factors associated with postoperative satisfaction with an extended depth of focus IOL.

Methods
Patients who underwent a refractive lens exchange with bilateral implantation of the AT LARA 829MP IOL and attended 3 months follow-up visit were included in analysis (n=351 patients). Demographics, preoperative and postoperative clinical parameters and patient-reported outcomes were used in a regression model to find predictors of 3 months postoperative satisfaction with vision.

Results
The mean age of the study group was 58.2 ± 7.0 years (range: 45 to 79) and the mean preoperative sphere ranged between -12.50 D and +6.75 D. At three months, 85.5% of eyes were within ±0.50 D of emmetropia, 90.6% achieved binocular uncorrected distance visual acuity of 20/20 or better and 92.0% of patients achieved binocular near vision of 20/50 or better. Logistic regression identified postoperative glare, patient-reported dry eye symptoms and binocular near and distance visual acuity as significant independent factors affecting patient satisfaction.

Conclusion
Patient satisfaction can be increased through proper management of early symptoms of dry eye. Focusing on refractive predictability can help to maximize the unaided vision achieved and further improve satisfaction rates. Patients should be counseled about the possibility of visual phenomena in the early postoperative period.
Single-Site Binocular Visual and Refractive Outcomes with a Novel Non-Diffractive Extended Vision Intraocular Lens
Authors
T. Hunter Newsom, MD, ABO
Jessie Lemp-Hull, PhD

Purpose
To evaluate clinical outcomes of binocular implantation of a new non-diffractive extended vision intraocular lens.

Methods
Single-site clinical results from a prospective, multi-center, assessor- and subject-masked, randomized, confirmatory trial with a 6-month follow up were analyzed. Subjects were bilaterally implanted after routine cataract surgery with either the AcrySof IQ Vivity IOL (Model DFT015) IOL (n=11) or SN60WF (n=11) IOL. Uncorrected and distance corrected photopic binocular visual acuities (UCVA, DCVA) at distance (4 m), intermediate (66 cm) and near (40 cm) from spectacle plane were evaluated (M&S Technologies) and are reported in logMAR.

Results
The DFT015 binocular defocus curve demonstrated better than 20/32 VA from distance to -2.0D (50cm). Binocular uncorrected and distance corrected VAs were 20/20, 20/25, and 20/32 or better for DFT015 at distance, intermediate and near respectively; and 20/20, 20/32, and 20/50 or better for SN60WF at each distance. For both groups, the majority of subjects were not at all bothered by starbursts, halos, and glare and rates were similar for DFT015 as compared to SN60WF.

Conclusion
Based on this site level data, the novel non-diffractive extended vision IOL provides an extended range of vision from distance to functional near. In comparison with an aspheric monofocal IOL, it improves near and intermediate vision without affecting distance vision while maintaining a monofocal visual disturbance profile.
Multi-Country Clinical Outcomes of a New Non-Diffractive Extended Vision Intraocular Lens
Authors
Chandra Bala, MBBS, PhD, FRANZCO
Jessie Lemp-Hull, PhD

Purpose
To evaluate clinical outcomes of binocular implantation of a new non-diffractive extended vision intraocular lens, AcrySof IQ Vivity Model DFT015.

Methods
154 and 119 subjects were bilaterally implanted with the DFT015 and SN60WF (monofocal control), respectively at 19 sites in Canada, UK, Spain and Australia. At 6 months post-op, monocular primary and secondary endpoints of best corrected distance (CDVA, 4m), distance corrected intermediate (DCIVA, 66cm) and distance corrected near visual acuity (DCNVA, 40cm) and defocus curves were assessed. Binocular uncorrected distance (UDVA), intermediate (UIVA), and near visual acuity (UNVA) and defocus curve were also assessed along with quality of vision (QoV Questionnaire, McAlinden) and overall safety.

Results
DFT015 demonstrated non-inferior monocular CDVA, superior DCIVA, superior DCNVA and >0.5D extended range of vision at 0.2 logMAR compared to SN60WF. DFT015 provided 20/20 binocular UDVA; and >half a line improvement in UIVA and > 1 line improvement in UNVA compared to SN60WF. For both groups, the majority of subjects were not at all bothered by starbursts, halos, and glare; and reported rates of severe visual disturbances were low (<4%). Rates of adverse events and of clinically non significant or significant PCO and YAG were low and similar between groups.

Conclusion
In comparison with an aspheric monofocal IOL, this non-diffractive extended vision IOL improves near and intermediate vision without affecting distance vision while maintaining a monofocal-like visual disturbance profile.
Single Site Clinical Outcomes of a New Non-Diffractive Extended Vision Intraocular Lens
Authors
Cathleen M. McCabe, MD
Brian B Foster, MD, ABO

Methods
9 randomized subjects were bilaterally implanted with the DFT015 and 9 with SN60WF (monofocal control), respectively at a single US site. At 6 months post-op, MRSE prediction error and binocular uncorrected and best corrected distance (UDVA, CDVA, 4m), intermediate (UIVA, DCIVA, 66cm) and near visual acuity (UNVA, DCNVA, 40cm) were assessed. Quality of vision (QUVID Questionnaire, Alcon) was also assessed at 6 months.

Results
100% and 89% of eyes implanted with DFT015 and SN60WF respectively achieved an absolute MRSE prediction error of 0.5D or less. Binocular UDVA and CDVA were 20/20 or better for both DFT015 and SN60WF. DFT015 provided > 1 line improvement in DCIVA, UIVA, DCNVA and UNVA compared to SN60WF. For both groups, the majority of subjects were not at all bothered by starbursts, halos, and glare and rates were similar between groups.

Conclusion
In comparison with an aspheric monofocal IOL, these site level results indicate that the non-diffractive extended vision IOL improves near and intermediate vision without affecting distance vision while maintaining a monofocal visual disturbance profile.

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