Prevalence of keratoconus and keratoconus suspect, and their characteristics on corneal tomography in a population-based study

Hiroyuki Namba; Naoyuki Maeda; Hiroshi Utsunomiya; Yutaka Kaneko; Kenichi Ishizawa; Yoshiyuki Ueno; Koichi Nishitsuka

doi:10.1371/journal.pone.0308892

Peer Review History

Original SubmissionAugust 30, 2023
11 Jun 2024 Decision Letter - Timo Eppig, Editor PONE-D-23-15898Prevalence of keratoconus and keratoconus suspect, and their characteristics on corneal tomography in a population-based studyPLOS ONE Dear Dr. Namba, 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 consider the literature mentioned by Reviewer 2 and address the issues about the age limitation mentioned by both reviewers. Please submit your revised manuscript by Jul 26 2024 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. We note that you have included the phrase “data not shown” in your manuscript. Unfortunately, this does not meet our data sharing requirements. PLOS does not permit references to inaccessible data. We require that authors provide all relevant data within the paper, Supporting Information files, or in an acceptable, public repository. Please add a citation to support this phrase or upload the data that corresponds with these findings to a stable repository (such as Figshare or Dryad) and provide and URLs, DOIs, or accession numbers that may be used to access these data. Or, if the data are not a core part of the research being presented in your study, we ask that you remove the phrase that refers to these data. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. 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: Yes 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: No Reviewer #2: No ****** 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: The authors aimed to determine the prevalence of keratoconus (KC), investigate the corneal tomographic features of KC and keratoconus suspect (KCS) using corneal tomography, and develop predictive models for KC and KCS based on corneal tomography, comparing those with and without corneal tomography. However, there are methodological errors in this study, and it needs improvement. 1. The identification of participants in this study is referenced to an article from 1999. However, it was stated that data from 2015-2016 and 2017 were obtained and evaluated after mentioning this. It is essential to provide a clear explanation of the population included in the study. 2. In the literature, there is a population-based keratoconus prevalence study using corneal tomography.* https://doi.org/10.1371/journal.pone.0308892.r001
Revision 1
17 Jun 2024 Author Response The responses to the comments of the reviewers Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf RESPONSE: Thank you for the comment, and we revised our manuscript to meet PLOS ONE's style requirements (title page, paragraphs, etc.). 2. We note that you have included the phrase “data not shown” in your manuscript. Unfortunately, this does not meet our data sharing requirements. PLOS does not permit references to inaccessible data. We require that authors provide all relevant data within the paper, Supporting Information files, or in an acceptable, public repository. Please add a citation to support this phrase or upload the data that corresponds with these findings to a stable repository (such as Figshare or Dryad) and provide and URLs, DOIs, or accession numbers that may be used to access these data. Or, if the data are not a core part of the research being presented in your study, we ask that you remove the phrase that refers to these data. RESPONSE: Thank you for your point out. The associations of sex differences with ocular parameters are not the focus of our research. Therefore, we deleted the sentence containing the phrase "data not shown". We revised our paper as below: (Lines 388- 392 in Revised Manuscript with Track Changes) “In our study, no sex differences in prevalence were found in KC/KCS. The sex-specific difference in KC may remain controversial.” Comments to the Author 3. Have the authors made all data underlying the findings in their manuscript fully available? Reviewer #1: No Reviewer #2: No RESPONSE: My apologies, it seems that the file we uploaded was incomplete. So we revised and uploaded the files again, separating them into eye- and person-specific data. And we revised our paper as below: (Lines 193 - 195 in Revised Manuscript with Track Changes) “Our data are available at: https://doi.org/10.6084/m9.figshare.26039557.” 5. Review Comments to the Author Reviewer #1: The authors aimed to determine the prevalence of keratoconus (KC), investigate the corneal tomographic features of KC and keratoconus suspect (KCS) using corneal tomography, and develop predictive models for KC and KCS based on corneal tomography, comparing those with and without corneal tomography. However, there are methodological errors in this study, and it needs improvement. 1. The identification of participants in this study is referenced to an article from 1999. However, it was stated that data from 2015-2016 and 2017 were obtained and evaluated after mentioning this. It is essential to provide a clear explanation of the population included in the study. RESPONSE: Thank you for this point out, and I apologize for the confusing wording. The basic structure of the study, including the division of the health examination schedule and the method of consent, follows that of the Yamagata study (Funagata study), so the paper from 1999 is also included in the references. The subjects of this study and the data obtained were newly examined and obtained from 2015 to 2017. We revised our paper as below: (Lines 96 - 105 in Revised Manuscript with Track Changes) “This study was conducted as part of the Yamagata Study, a population-based epidemiological investigation examining systemic and ophthalmologic disorders in Japanese individuals aged ≥ 35 years [40–44]. Present research was performed in accordance with the residual medical checkups in Funagata town which was divided into three areas: Funagata, Horiuchi, and Nagasawa areas in terms of schedule. Systemic and ophthalmic data included in this research were collected from residents of Funagata area on June 14 and 28, 2015; Horiuchi area on June 4 and 19, 2016; and Nagasawa area on June 4, 2017.” 2. In the literature, there is a population-based keratoconus prevalence study using corneal tomography.* RESPONSE: Thank you for the comment, and I apologize for the confusing wording again. We are not thinking that this is the first population-based study using tomography, but that this may be the first paper that color map “patterns” of the anterior and posterior surface and corneal thickness from tomography have been evaluated in a population-based design. We revised our paper as below: (Lines 379 - 383 in Revised Manuscript with Track Changes) “The population-based evaluation of the color map patterns of anterior and posterior corneal surfaces may be a unique feature of this study.” Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0308892.r002
12 Jul 2024 Decision Letter - Timo Eppig, Editor PONE-D-23-15898R1Prevalence of keratoconus and keratoconus suspect, and their characteristics on corneal tomography in a population-based studyPLOS ONE Dear Dr. Namba, 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. Could you please consider the comments #3-#7 from reviewer one which were in the original revision but due to a technical error the comments have not been forwarded to the authors. Please submit your revised manuscript by Aug 26 2024 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Timo Eppig Academic Editor PLOS ONE [Note: HTML markup is below. Please do not edit.] 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 #1: (No Response) ******** 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 #1: 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 #1: 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 #1: Although the authors have sufficiently provided feedback for the first two of my comments, my comments #3 - 7 have not been addressed. 3. Keratoconus suspect is defined as the presence of keratoconus patterns on the anterior axial power map. After the development of corneal tomography devices, it is accepted that keratoconus develops from the posterior surface of the cornea. In this case, keratoconus suspect should primarily involve changes in the posterior surface patterns. The current definition might have missed keratoconus-suspected patients. 4. The mean age of patients is considerably higher than the typical age of keratoconus diagnosis. Were the patients diagnosed with keratoconus in this study newly diagnosed cases who had not received a diagnosis before the study? The presence of patients who had undergone treatments like CXL is not specified in the study. 5. It is recommended to remove soft and rigid contact lenses at least 1 week before keratometric measurements. Were the patients' contact lenses removed before measurements? 6.As a result of the study, using axial length in keratoconus suspect cases is not a clinically appropriate approach. 7. Determining sensitivity and specificity values in a study with 822 participants, including 7 keratoconus and 12 keratoconus-suspected patients, will not provide objective results. ****** 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 #1: 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.0308892.r003
Revision 2
15 Jul 2024 Author Response I'm sorry for the lack of responses to the comments #3-#7. We were unable to receive the comments due to a technical error. Reviewer #1: 3. Keratoconus suspect is defined as the presence of keratoconus patterns on the anterior axial power map. After the development of corneal tomography devices, it is accepted that keratoconus develops from the posterior surface of the cornea. In this case, keratoconus suspect should primarily involve changes in the posterior surface patterns. The current definition might have missed keratoconus-suspected patients RESPONSE: Thank you for the comment. In our research, we involved changes in both the anterior and posterior surfaces of the cornea as KC and KCS. Cases with only posterior surface changes are defined as forme fruste keratoconus (FFK) and are not included in our study. The reason for this is that there were only a few cases of FFK in this study, and they were either KC or KCS. There were no cases with only posterior changes in both eyes. We revised our paper as below: (Lines 137-140 in Revised Manuscript with Track Changes) “KCS was defined as eyes that had visual acuity 20/20 or better and keratoconus patterns in the anterior and posterior corneal surfaces (Fig 4) [3,31-34]. Because there were few eyes with forme fruste keratoconus, which has irregularity only on the posterior surface, we did not include them.” 4. The mean age of patients is considerably higher than the typical age of keratoconus diagnosis. Were the patients diagnosed with keratoconus in this study newly diagnosed cases who had not received a diagnosis before the study? The presence of patients who had undergone treatments like CXL is not specified in the study. RESPONSE: Thank you for your comment. We included KC whether newly diagnosed or previously diagnosed. One eye that had previously undergone a keratoplasty was excluded as a case with insufficient data in the ocular examination. Eyes that had undergone CXL were not included. CXL is not yet widely used in rural areas of Japan. We revised our paper as below: (Lines 4- 9 in Figure 2) “Insufficient data (missing, error, decentering, eyelid interferences, and abnormal corneal shape except for KC), an eye that has undergone a keratoplasty, and 2 eyes with pellucid marginal degeneration (n = 316)” 5. It is recommended to remove soft and rigid contact lenses at least 1 week before keratometric measurements. Were the patients' contact lenses removed before measurements? RESPONSE: Thank you for your point out. It is correct and we would have done the same if we could have. However, due to the limitation of a joint medical checkup project with the Department of Internal Medicine, and because prior restrictions on contact lens use would lead to inconvenience in daily life, we requested it, but it was difficult to enforce it. 6.As a result of the study, using axial length in keratoconus suspect cases is not a clinically appropriate approach. RESPONSE: Thank you for your comment. You raise a valid point, and the axial length measurement may not be accurate in KC with corneal shape abnormalities. However, in the investigations of KC risk assessment, our goal is to use the data obtained from clinical examinations to make a diagnosis of KC. I think the accuracy of axial length measurement in KC may not be an essential issue. 7. Determining sensitivity and specificity values in a study with 822 participants, including 7 keratoconus and 12 keratoconus-suspected patients, will not provide objective results. RESPONSE: I think you have a valid point. I think the number of cases may not be sufficient to calculate an epidemiologically accurate prevalence. However, the prevalence of KC in Japan has not been adequately studied in the past, and it is relatively close to the prevalence in China also in East Asia, therefore, I think we were able to show some significance. We indicated the limitation on the line 432-433. OPTIONAL: We unified the terms "person-wise" and "eye-wise" into "person-specific" and "eye-specific" as below: (Lines 206 in Revised Manuscript with Track Changes) “Table 1. Person-specific characteristics in non-KC, KCS, and KC subjects.” (Lines 222 in Revised Manuscript with Track Changes) “Table 2. Eye-specific characteristics in non-KC, KCS, and KC subjects.” Attachments Attachment Submitted filename: 240713_Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0308892.r004
1 Aug 2024 Decision Letter - Timo Eppig, Editor Prevalence of keratoconus and keratoconus suspect, and their characteristics on corneal tomography in a population-based study PONE-D-23-15898R2 Dear Dr. Namba, 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 #1: 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 #1: 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 #1: 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 #1: All previously raised issues have been appropiately addressed and the manuscript now reads suitable for publication. ****** 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 #1: Yes: Eray Atalay ******** https://doi.org/10.1371/journal.pone.0308892.r005
Formally Accepted
1 Dec 2024 Acceptance Letter - Timo Eppig, Editor PONE-D-23-15898R2 PLOS ONE Dear Dr. Namba, 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 If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks 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.0308892.r006

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