2021 ASCRS Annual Meeting

Authors

Presenting Author
P. Dee G. Stephenson, MD, FACS, ABO, FACS    Email the author

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Paper Abstract

Purpose
To evaluate long-term incidence of IOL vaulting and tilt or secondary surgical intervention following implantation of Trulign Toric IOL (Bausch and Lomb, Inc.)

Methods
Prospective, multicenter, open-label, single-arm, post-approval safety study in the US. All eligible subjects were consecutively enrolled and followed through 3 years. All eyes were treated in accordance with IOL labeling instructions. Post-operatively, all eyes underwent ophthalmic examinations according to each surgeon’s standard of care.

Results
A total of 698 eyes of 442 subjects from 30 sites in the US were enrolled. The average age of subjects were 68.4 years (SD: 8.8) with 44.6% male and 55.4% female. Most subjects (598 eyes or 85.7%) completed the study through the 3-year follow-up. Two eyes (0.29%) experienced clinically significant IOL vault. The first was identified at Visit 3 (1-2M) and the second was identified at Visit 4 (4-6M). Both subjects required secondary surgical intervention with IOL exchange or IOL repositioning with capsular tension ring for zonular dehiscence. Sixty-six eyes (9.62%) were treated with Nd:YAG to prophylactically prevent capsular contraction syndrome.

Conclusion
The post-approval 3-year safety outcomes showed less incidence of vaulting when compared to its pre-approval FDA results (Post-approval 0.29% vs. Pre-Approval 0.9%). Prophylactic YAG treatments in this study may have helped in minimizing capsular contraction syndrome and lens vaulting.

Authors

Presenting Author
Kevin M Barber, MD, ABO    Email the author

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Paper Abstract

Purpose
To quantitatively assess the rotational stability of an EDOF Toric IOL immediately following placement, post-op day 1, week 1, and week 4, utilizing a digital marking system. Secondary objectives assessed residual astigmatism, absolute prediction error and monocular uncorrected and best corrected vision at distance and intermediate focal planes.

Methods
This prospective, noncomparative single-arm, single surgeon study evaluated a total of 35 patients undergoing cataract extraction with lens implantation requiring an IOL power +15.0D to +25.0D, corneal astigmatism between 0.75-2.25D, and otherwise no identifiable visually compromising ocular pathology. IOL implantation employed digital markers and intraoperative aberrometry. Digital markings were taken and analyzed at all planned post-operative visits, with data compared for rotational stability. At each time point, residual optical astigmatism, absolute prediction error, and visual acuities were noted.

Results
This study confirmed the original hypothesis and completion of the initially stated objectives. No patient experienced a post-op rotation greater than 5˚ at the POM1 interval with the mean at 2.6˚± 0.8. The percentage of eyes with absolute prediction error < 0.5D was 94.3% (p < 0.001), with residual astigmatism < 0.5D was 94.3% (p < 0.001), and with residual astigmatism < 1.00D was 100%. The monocular logMAR uncorrected and best corrected vision were taken with distance vision at (0.18±0.02, 0.08±0.02) and intermediate at (0.27±0.04, 0.17±0.03). There was no statical difference in BCVA/UCVA in patients whom ORA recommended a change of > 5 degrees of axis alignment.

Conclusion
In conclusion, this study confirmed all prior objectives and goals. The study found the rotational stability of the Vivity Toric IOL to be excellent verified by photographic analysis of a digital marking system. In addition, the ORA system helps in validating and reaffirming preoperative measurements with the Vivity Toric IOL.

Authors

Presenting Author
P. Dee G. Stephenson, MD, FACS, ABO, FACS    Email the author

Video Presentation

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Paper Abstract

Purpose
To evaluate refractive and visual acuity outcomes in patients implanted with low diopter toric (1.25D) monofocal IOLs using Intraoperative aberrometry as compared to patients implanted with spherical non-toric equivalent in cataract patients with mild amounts of corneal astigmatism

Methods
Retrospective, single-surgeon, comparative case series of cataract patients with mild corneal astigmatism (<1.0D) implanted with either enVista spherical IOL or low diopter (1.25D) enVista Toric IOL (Bausch and Lomb, Inc.). Intra-operative aberrometry was used to minimize post-operative ametropia. Study endpoints include pre-op keratometry, post-op manifest refraction, uncorrected and best corrected distance visual acuities.

Results
Visual acuity outcomes at 3M (toric: n=30; non-toric: n=78) showed improved uncorrected distance visual acuity in the toric group versus non-toric (20/25 or better: 93% vs 70%). Nearly all eyes (≥ 98%) in both groups displayed good best corrected distance visual acuity of 20/20 or better. Post-op refractive astigmatism was slightly better in the toric group compared to the non-toric group (% of eyes with ≤ 0.25D: 60% vs 44%).

Conclusion
The use of low diopter toric IOL improved refractive and visual acuity outcomes when compared to its non-toric equivalent. The use of new lower diopter toric lenses can improve clinical outcomes and expand treatment options for cataract patients with mild amounts of corneal astigmatism confirmed by ORA

Authors

Presenting Author
Michael G Orr, MD, ABO    Email the author

Video Presentation

Paper Abstract

Purpose
To compare the need for postoperative enhancement of astigmatism correction following toric IOL alignment with either automated femtosecond laser image guided iris registration versus intraoperative aberrometry.

Methods
Retrospective chart review of enhancement rates & toric IOL refractive outcomes in 1018 cases performed with IntelliAxis automated image guided iris registration (LENSAR, Orlando,FL) from July 2018 to December 2019 & 773 cases performed with ORA System intraoperative aberrometry (Alcon, Ft. Worth,TX) from January 2016 to May 2018. The indication for enhancement procedures was primarily based on patient dissatisfaction. Second enhancement procedures included LVC, IOL rotation for misalignment or astigmatic keratotomy. Measured outcomes include enhancement rates, uncorrected visual acuity, residual refractive astigmatism, postoperative manifest refraction spherical equivalent & complications.

Results
Analysis of the chart reviews revealed higher enhancement rates in the intraoperative aberrometry group compared with Intelliaxis-L group (7.12% vs 1.38%; p<.001). Mean pre-enhancement spherical equivalent refraction was -0.65 ± 0.65 D in the intraoperative aberrometry group and -0.52 ± 0.90 D in the Intelliaxis-L group. Mean pre-enhancement astigmatic cylinder was 1.44 ± 0.76 D in the intraoperative aberrometry group and 1.93 ± 1.57 D in the Intelliaxis-L group.

Conclusion
Automated image guided iris registration toric IOL alignment may provide reduced enhancement rates and superior patient satisfaction compared with intraoperative aberrometry. Reduction in enhancement rate can represent a significant cost savings.

Authors

Presenting Author
Andrew A. Kao, MD, ABO    Email the author
Authors
Maria C. Scott, MD, Joy O Domingo, MD, Srividhya S. Vilupuru, OD, Wuchen Zhao, MS, D. Priya Janakiraman, OD

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Paper Abstract

Purpose
The purpose of this study was to evaluate surgeon satisfaction with rotational stability and visual outcomes in eyes implanted with the TECNIS Toric II IOL (Models, ZCU 1.50 to 6.0 D) with modified haptics design.

Methods
Prospective, multi-center, singe-arm study. 10 surgeons from 7 sites implanted the IOL in 86 eyes of 54 subjects. Surgeons reported their brand preference for toric IOL prior to and after the completion of the study. For each implanted eye, the surgeon assessed their level of confidence with controlling the IOL position immediately following surgery and their satisfaction with the rotational stability at 1-week. Surgeon satisfaction with overall outcomes, rotational stability and uncorrected distance visual acuity were assessed at 3-months. Uncorrected (UCDVA), best-corrected (BCDVA) distance visual acuity and manifest refraction (MRSE) were evaluated at 3-months.

Results
70% of surgeons that preferred a different IOL prior to the study rated the rotational stability of the TECNIS Toric II IOL to be much or somewhat better to their preferred IOL. Surgeons were extremely or quite confident in controlling lens position in 96.6% of eyes. Surgeons were very satisfied or satisfied with rotational stability and overall outcomes in 98.8% and 100% of eyes at the 1-week and 3-month visits, respectively. Mean UCDVA was 20/21 with 92.2% of eyes achieving 20/25 or better. Mean MRSE was -0.22 D ± 0.42 D. The mean preoperative keratometric cylinder of 1.73 D ± 0.85 D was reduced to a mean refractive residual cylinder of 0.16 D ± 0.25 D.

Conclusion
TECNIS Toric II IOL with the squared and frosted haptics design demonstrates low residual refractive astigmatism, excellent uncorrected vision, high levels of surgeon confidence in controlling the lens position and satisfaction with rotational stability and overall clinical outcomes.

Authors

Presenting Author
Denise M. Visco, MD, MBA, ABO    Email the author

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Paper Abstract

Purpose
To investigate refractive outcomes of toric IOL alignment with automated femtosecond laser image guided iris registration and compare with results reported in the peer-reviewed literature.

Methods
Retrospective chart review of refractive outcomes in 71 cases performed with IntelliAxis-C corneal marks and 142 cases performed with IntelliAxis-L capsular marks using automated image guided iris registration for alignment of toric IOLs (LENSAR, Orlando, FL). Primary outcome measures include residual refractive astigmatism, enhancement rate and visual acuity.

Results
IntelliAxis-C and IntelliAxis-L achieved 79.0% and 81.0% ≤ 0.25 D and 94.0% and 95.0% ≤ 0.50 D residual refractive astigmatism, respectively. Mean residual refractive astigmatism was 0.17  0.35 D in the IntelliAxis-C group and 0.16  0.25 D in the IntelliAxis-L group. The enhancement rate was 2.8% in the IntelliAxis-C group and 0.7% in the IntelliAxis-L group. These results compare favorably with recent meta-analysis: 0.46  0.19 D for image guided and 0.62  0.29 D for manual surgery; 0.46  0.25 D has been reported for intraoperative aberrometry. The need for enhancement was comparable to rates reported for digital marking: 1.8% AcrySof Toric and 3.2% Tecnis Toric.

Conclusion
Automated image guided iris registration toric IOL alignment may provide superior refractive outcomes compared with other digital or manual methods.

★ This paper won Best Paper of Session (BPOS) at the 2021 ASCRS Annual Meeting

Authors

Presenting Author
Brent A. Kramer, MD    Email the author
Authors
David R. Hardten, MD, John P. Berdahl, MD

Video Presentation

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Paper Abstract

Purpose
To assess the effect rotation has on UDVA for two monofocal toric IOLs.

Methods
Retrospective review of entries made to the astigmatismfix.com website will be filtered and analyzed. Rotation/misalignment will be defined as and IOL >5° from the intended axis. The rate of rotation/misalignment will be determined by comparing the amount of entries to their respective rate of background residual astigmatism entries (an ‘internal validation’ method that has been used in previous astigmatismfix studies). The study will include data through the summer of 2021.

Results
Records of 3737 eyes were included in the analysis. Linear regression coefficients were statistically significant for all groups (T-test; p<0.001). These coefficients ranged from 0.0071 to 0.030 for the SN6T3-T9 (i.e. for each degree of rotation of an SN6T3, there was 0.0071 loss of LogMAR UDVA), and from 0.0072 to 0.034 for the ZCT100-600. There was no statistical difference when comparing the regression slopes of AcrySof and TECNIS (T-test; p<0.05). The amount of rotation required to induce 20/25 and 20/40 Snellen UDVA were also calculated.

Conclusion
Higher powered toric IOLs decrease UDVA more per degree of misalignment, but there is no difrerence in misalignment tolerability between AcrySof and TECNIS toric IOLs.

Authors

Presenting Author
Brent A. Kramer, MD    Email the author
Authors
David R. Hardten, MD, John P. Berdahl, MD

Video Presentation

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Paper Abstract

Purpose
Analysis of trends from astigmatismfix to evaluate rotational trends of the TECNIS II toric IOL.

Methods
Retrospective review of entries made to the astigmatismfix.com website will be filtered and analyzed. Rotation/misalignment will be defined as and IOL >5° from the intended axis. The rate of rotation/misalignment will be determined by comparing the amount of entries to their respective rate of background residual astigmatism entries (an ‘internal validation’ method that has been used in previous astigmatismfix studies). The study will include data through the summer of 2021.

Results
The first TECNIS II entry to AstigmatismFix was made on 12/16/2019. A total of 6,381 validated entries were made between 12/16/2019-6/4/2021. Regarding monofocal IOLs during this time, the rate of rotation for AcrySof was 71.6% (1426/1993), TECNIS 82.9% (929/1121), TECNIS II 67.9% (203/299), enVista 79.3% (134/169). The first PanOptix entry was made on 10/26/2019. A total of 7,233 validated entries were made between 10-26/2019-6/4/2021. The rate of rotation for PanOpxtix was 71.8% (759/1057) and for Symfony 77.8% (421/541).

Conclusion
The TECNIS Toric II has improved rotational stability compared to the original Tecnis Toric platform and appears to have a similar rotational stability as the AcrySof platform.