Comparison of visual performance between monofocal and rotationally asymmetric refractive intraocular lenses

Masaki Miyoshi; Hirotaka Tanabe; Tomohiro Shojo; Tomofusa Yamauchi; Kosuke Takase; Hitoshi Tabuchi

doi:10.1371/journal.pone.0323625

Peer Review History

Original SubmissionAugust 16, 2024
16 Aug 2024 Author Response https://doi.org/10.1371/journal.pone.0323625.r001
11 Dec 2024 Decision Letter - Timo Eppig, Editor PONE-D-24-34677Comparison of visual performance between monofocal and rotationally asymmetric refractive intraocular lensesPLOS ONE Dear Dr. Tanabe, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ============================== Please check the quality of the figures as indicated by Reviewer 1 and consider the comments of Reviewer 2 in your revised version. ============================== Please submit your revised manuscript by Jan 25 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . 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Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: I Don't Know ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: I suggest that improve the quality of Figures 1, 2 and 3 becuase it is somehow hard to reed the numbers and letters. However, based on my knowledge and understanding from the paper, I think the manuscript is prepared properly in the style of scientific paper. Reviewer #2: Thank you for this paper, where you compare two lenses with an impressive number of subject. Even though the number of patients is impressive, the findings are less surprising. Further I would rather look for papers, comparing specific monofocal IOLs with each other or multifocal IOLs with each other. Then one could really draw conclussions, that help patients and surgeons. Although the paper is well written and the statitics probably very good, I have difficulties recommending this paper for publications. Please see my additional comments and questions below: Abstract Remove the list of higher order aberrations. It is sufficient to have it in the text. Row 46/47: rephrase “is designed to focus 95% of the time”. It is misleading. Row 116/117: “No boundary” is wrong. Specify clearly what is meant. Is there a sharp edge or a smooth transition zone? Row 118: “Twenty surgeons” Did you look for different results according to the variable surgeon? Row 134: Why did you use more than 10 times the data that you calculate to be needed? What is the benefit? Statical analysis over time??? Were the first years as good as the last ones, were the better or worse years? Table 1: Please specify, whether it contains mean+-standard deviation or mean+-standard error with a confidence interval of … % in the caption Please reduce the number of digits to the number of significant digits Row 277-280: How do you explain, that contrast sensitivity was superior in the Lentis group? One could assume that the monofocal wins this match. Row 289: Specify the meaning of a high Abbe number. What is the true effect of having an Abbe number of 55 or 57. Is there a real difference, that explains the contrast sensitivity? The eye itself already has a high chromatic aberration. I doubt, that the effect is really present. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy . Reviewer #1: Yes: Maziar Mirsalehi Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org . Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0323625.r002
Revision 1
6 Mar 2025 Author Response Hirotaka Tanabe, MD, PhD Department of Ophthalmology Tsukazaki Hospital 68-1 Waku, Aboshi-ku, Himeji, Hyogo 671-1227, Japan Tel.: +81-79-272-8555; Fax: +81-79-272-8550; Email: tennsyoudragon@icloud.com Editor-in-Chief March 6, 2025 Dear Editor-in-Chief: We would like to attach our response to the editor and reviewers regarding our manuscript, “Comparison of visual performance between monofocal and rotationally asymmetric refractive intraocular lenses,” by Masaki Miyoshi, MD, Hirotaka Tanabe, MD, PhD, and colleagues, submitted as a research article for potential publication in Scientific Reports. Editor comments Dear Dr. Tanabe, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please check the quality of the figures as indicated by Reviewer 1 and consider the comments of Reviewer 2 in your revised version. Response Thank you very much for your excellent guidance. We have revised the manuscript in response to all the suggestions proposed in the review, and all revised text has been highlighted in yellow in a separate file. We genuinely appreciate your consideration of our manuscript. Reviewer 1 I suggest that improve the quality of Figures 1, 2 and 3 becuase it is somehow hard to reed the numbers and letters. However, based on my knowledge and understanding from the paper, I think the manuscript is prepared properly in the style of scientific paper. Response Thank you for your positive comments and invaluable guidance for our manuscript. We have revised Figures 1-3 to improve legibility by removing the repetitions of the letters and redesigning them as much as possible while preserving the information. We have added the following sentences to the legends of Figures 1 and 3, respectively: "Non-WF (a), WF_4/6_post O (b), and WF_4/6_post I (c)." and "Nonvision/nondriving (a), vision (b), and driving (c)." We have also added the following sentence to the Acknowledgment section: "Wiley Editing Services formatted the figures.". Reviewer 2 Thank you for this paper, where you compare two lenses with an impressive number of subject. Even though the number of patients is impressive, the findings are less surprising. Further I would rather look for papers, comparing specific monofocal IOLs with each other or multifocal IOLs with each other. Then one could really draw conclussions, that help patients and surgeons. Although the paper is well written and the statitics probably very good, I have difficulties recommending this paper for publications. Response Thank you for your invaluable comments on our manuscript. In Japan, the ZCB00 monofocal IOL is fairly popular, while the Lentis Comfort IOL was the first nonmonofocal IOL covered by insurance; both have substantially impacted Japanese society. We have added the following sentences to the Introduction to address this issue: "In Japan, the ZCB00 is one of the most commonly used monofocal IOLs, whereas the LS-313 MF15, which features a rotationally asymmetric design and a +1.5 diopter near addition, was the first nonmonofocal IOL to be approved by insurance. Given their substantial impact on Japanese society, we conducted a retrospective study to compare the visual performance of these two types of IOLs." Please see my additional comments and questions below: Abstract Remove the list of higher order aberrations. It is sufficient to have it in the text. Response Thank you for your invaluable guidance on our manuscript. We have removed the list of higher-order aberrations from the Abstract. Row 46/47: rephrase “is designed to focus 95% of the time”. It is misleading. Response Thank you for your invaluable guidance for our manuscript. We have revised the sentence to "The lens has an optical loss of only 5%, resulting in good postoperative contrast sensitivity." Row 116/117: “No boundary” is wrong. Specify clearly what is meant. Is there a sharp edge or a smooth transition zone? Response Thank you for your invaluable guidance for our manuscript. We have changed this text to "a smooth transition zone." Row 118: “Twenty surgeons” Did you look for different results according to the variable surgeon? Response Thank you for your invaluable guidance for our manuscript. We confirmed that all surgeons at the hospital where this study was performed carefully followed the same protocols and that the procedures were thoroughly standardized. Therefore, we believe that the differences among surgeons were limited, and thus we did not add the surgeon as a random effect in the mixed-effects model employed in this analysis. We have added the following sentence to the Discussion section to address this issue: "We confirmed that all surgeons carefully adhered to the same protocols, ensuring thorough standardization of the procedures. As a result, we believe that variation among surgeons is minimal. Therefore, we did not include the surgeon as a random effect in the mixed-effects model used in this analysis when accounting for any potential biases in performance. The presence of multiple surgeons, each with a sufficient number of patients, resulted in a robust sample for our study." Row 134: Why did you use more than 10 times the data that you calculate to be needed? What is the benefit? Statical analysis over time??? Were the first years as good as the last ones, were the better or worse years? Response Thank you for your invaluable guidance for our manuscript. As you noted, 1,352 eyes from 676 patients met the selection criteria for this study, which is significantly larger than the required sample size determined from the power calculations on the basis of the logMAR effect size derived from previous studies. Since the objective of this study was also to conduct an exploratory analysis of trends for other observable factors, we chose to employ the entire population for our analysis. Another reason for this decision was to avoid any potential biases that could arise from selectively sampling the population under analysis. We have added the following sentence to the Discussion section to address this issue: "A total of 1,352 eyes from 676 patients met the selection criteria for this study, which is significantly larger than the required sample size determined from the power calculations on the basis of the logMAR effect size derived from previous studies. Since the objective of this study was also to conduct an exploratory analysis of trends for other observable factors, we chose to employ the entire population for our analysis. Another reason for this decision was to avoid any potential biases that could arise from selectively sampling the population under analysis." Table 1: Please specify, whether it contains mean+-standard deviation or mean+-standard error with a confidence interval of … % in the caption Please reduce the number of digits to the number of significant digits Response Thank you for your invaluable guidance for our manuscript. Regarding the values in the table, we added a caption stating, "In this table, categorical variables are presented as the counts and frequencies, whereas continuous variables are presented with the number of samples (excluding those with missing data) and the mean ± standard deviation." The number of significant digits for the mean and standard deviation has been modified to include one additional digit for the mean and two additional digits for the standard deviation. Row 277-280: How do you explain, that contrast sensitivity was superior in the Lentis group? One could assume that the monofocal wins this match. Response Thank you for your invaluable guidance for our manuscript. We have added the following sentence to the Discussion to address this issue: "In the present study, the contrast sensitivity of the rotationally asymmetric refractive IOL was comparable to or partially exceeded that of the monofocal IOL. The Lentis Comfort IOL is a multifocal intraocular lens designed to reduce optical loss. It features a smooth transition between the near and far portions of the lens, with only a mild difference in focus between each area; this design contributes to a mere 5% reduction in contrast sensitivity. Furthermore, unlike the ZCB00 IOL, the Lentis Comfort IOL is hydrophilic, which has been reported to increase the Abbe number [25]; indeed, although the Abbe number of the ZCB00 IOL is very high (55), that of the Lentis Comfort IOL is even greater (57) according to the manufacturer's reports. The Abbe number, or Vd-number, measures a transparent material's dispersion, indicating how the refractive index changes with wavelength. High Abbe numbers indicate low dispersion, which is crucial in the design of an IOLs; a lower Abbe number suggests greater chromatic aberration, resulting in decreased retinal image quality. The refractive indices of ocular media vary with wavelength, resulting in different focal points for colors and leading to chromatic aberrations and blurred images. The cornea and lens are the primary anatomical structures that contribute to these aberrations, with the crystalline lens responsible for approximately 28.5% of the total [26]. While typically manageable for patients with phakic eyes, longitudinal chromatic aberration can impact visual function in pseudophakic eyes equipped with low Abbe number IOLs, making the Abbe number of the IOL a key factor in contrast sensitivity differences [27,28]. For all the reasons listed above, the Lentis Comfort IOL seemed to have slightly but significantly better contrast sensitivity (6.3 degrees), contrast sensitivity with glare (4.0, 1.6, 1.0, 0.7 degrees), and significantly better contrast sensitivity with glare (6.3 degrees). In other words, there were no differences in most degrees of contrast sensitivity between the Lentis Comfort and ZCB00 IOLs in this study, despite the sufficient number of patients and rigorous statistical analysis involving a linear mixed-effects model with binocular data adjusted for age, sex, subjective refraction cylinder (CYL), subjective refraction spherical equivalent (SE), corneal astigmatism, axial length, pupil diameter, and corneal higher-order aberrations to ensure accurate results. Nevertheless, other confounding factors could explain the results." References 25. Eppig T, Rawer A, Hoffmann P, Langenbucher A, Schröder S. On the chromatic dispersion of hydrophobic and hydrophilic intraocular lenses. Optom Vis Sci. 2020;97: 305-313. 26. Uosato HHirai HFukuhara JMatsuura T Fundamentals of Visual Optics [in Japanese]. Tokyo, Japan Kanahara & Co1990; 27. Negishi K, Ohnuma K, Hirayama N, Noda T. Effect of chromatic aberration on contrast sensitivity in pseudophakic eyes. Arch Ophthalmol. 2001 Aug;119(8):1154-8. 28. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007 Sep;91(9):1225-9. Row 289: Specify the meaning of a high Abbe number. What is the true effect of having an Abbe number of 55 or 57. Is there a real difference, that explains the contrast sensitivity? The eye itself already has a high chromatic aberration. I doubt, that the effect is really present. Response Thank you for your invaluable guidance for our manuscript. We have added the following sentence to the Discussion to address this issue: "In the present study, the contrast sensitivity of the rotationally asymmetric refractive IOL was comparable to or partially exceeded that of the monofocal IOL. The Lentis Comfort IOL is a multifocal intraocular lens designed to reduce optical loss. It features a smooth transition between the near and far portions of the lens, with only a mild difference in focus between each area; this design contributes to a mere 5% reduction in contrast sensitivity. Furthermore, unlike the ZCB00 IOL, the Lentis Comfort IOL is hydrophilic, which has been reported to increase the Abbe number [25]; indeed, although the Abbe number of the ZCB00 IOL is very high (55), that of the Lentis Comfort IOL is even greater (57) according to the manufacturer's reports. The Abbe number, or Vd-number, measures a transparent material's dispersion, indicating how the refractive index changes with wavelength. High Abbe numbers indicate low dispersion, which is crucial in the design of an IOLs; a lower Abbe number suggests greater chromatic aberration, resulting in decreased retinal image quality. The refractive indices of ocular media vary with wavelength, resulting in different focal points for colors and leading to chromatic aberrations and blurred images. The cornea and lens are the primary anatomical structures that contribute to these aberrations, with the crystalline lens responsible for approximately 28.5% of the total [26]. While typically manageable for patients with phakic eyes, longitudinal chromatic aberration can impact visual function in pseudophakic eyes equipped with low Abbe number IOLs, making the Abbe number of the IOL a key factor in contrast sensitivity differences [27,28]. For all the reasons listed above, the Lentis Comfort IOL seemed to have slightly but significantly better contrast sensitivity (6.3 degrees), contrast sensitivity with glare (4.0, 1.6, 1.0, 0.7 degrees), and significantly better contrast sensitivity with glare (6.3 degrees). In other words, there were no differences in most degrees of contrast sensitivity between the Lentis Comfort and ZCB00 IOLs in this study, despite the sufficient number of patients and rigorous statistical analysis involving a linear mixed-effects model with binocular data adjusted for age, sex, subjective refraction cylinder (CYL), subjective refraction spherical equivalent (SE), corneal astigmatism, axial length, pupil diameter, and corneal higher-order aberrations to ensure accurate results. Nevertheless, other confounding factors could explain the results." References 25. Eppig T, Rawer A, Hoffmann P, Langenbucher A, Schröder S. On the chromatic dispersion of hydrophobic and hydrophilic intraocular lenses. Optom Vis Sci. 2020;97: 305-313. 26. Uosato HHirai HFukuhara JMatsuura T Fundamentals of Visual Optics [in Japanese]. Tokyo, Japan Kanahara & Co1990; 27. Negishi K, Ohnuma K, Hirayama N, Noda T. Effect of chromatic aberration on contrast sensitivity in pseudophakic eyes. Arch Ophthalmol. 2001 Aug;119(8):1154-8. 28. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol. 2007 Sep;91(9):1225-9. Again, thank you very much for your consideration and excellent guidance for our manuscript. We look forward to hearing from you. Sincerely yours, Hirotaka Tanabe, MD, PhD Chief Ophthalmologist (Cataract, Vitreous, Glaucoma, and Oculoplastic Surgeon) Department of Ophthalmology, Tsukazaki Hospital ORCID: https://orcid.org/0000-0002-1948-7408 Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0323625.r003
11 Apr 2025 Decision Letter - Timo Eppig, Editor Comparison of visual performance between monofocal and rotationally asymmetric refractive intraocular lenses PONE-D-24-34677R1 Dear Dr. Tanabe, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Timo Eppig Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #2: Thank you for your comments and the improved manuscript. Except my last question, everything was addressed properly. Anyway, from my point of view, the manuscript can be accepted. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy . Reviewer #2: No ******** https://doi.org/10.1371/journal.pone.0323625.r004
Formally Accepted
Acceptance Letter - Timo Eppig, Editor PONE-D-24-34677R1 PLOS ONE Dear Dr. Tanabe, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Prof. Dr. Timo Eppig Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0323625.r005

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