PONE-D-23-21962Evaluation of a new transpalpebral tonometer for self-measurement of intraocular pressurePLOS ONE

Dear Dr. Kobashi,

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.

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Academic Editor

PLOS ONE

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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: Partly

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: Yes

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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: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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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 manuscript by Kobashi describes TapEye tonometer (TET), a novel transpalpebral self-tonometer, to obtain intraocular pressure (IOP) measurement based on palpation of the upper eyelid. They found that the corrected-IOP value measured by the TET (c-TET), calculated based on the difference between the TET and GAT measurements at the first visit, was correlated with GAT measurements. The TET has the potential to meet the need for minimally invasive IOP measurements. Although the topic area is potentially interesting, but I do have some concerns regarding the level of experimental detail provided and a lack of clarity in the presentation and description of the data that makes it difficult to establish conclusions from the study.

1. Firstly, the author measure the IOPs of several 3D-printed eyeball models with various central corneal thicknesses using TET and Tono-Pen AVIA tonometers. Do these models have just eyeballs, or do they also have eyelids?

2. Could the level of stiffness of the eyelids affect the measurement results and how to correct that part?

3. With only one glaucoma patient among the participants, how accurate is TET performance in individuals with low or high intraocular pressure? With the lowest measured value being 1.6 in the c-TET group and 10 in the GAT group, the deviation is substantial. Does this indicate inadequate accuracy of TET measurements in cases of low intraocular pressure?

4. The subjects can seek help or receive instructions from technicians when using TET in both visits. How do they perform if there is no access to TET instructions? Are the results still reliable?

5. How many times of measurements are needed to obtain a TET IOP value which successfully pass the criteria? In a single measurement session, what range of differences between the data points is considered acceptable? Do the failure measurements affect the IOP value before a successful TET measurement is obtained?

6. The significant correlation between TET and GAT seems to rely on correction based on the difference between the TET and GAT measurements in visit 1. In this study, the visit interval is one month. Is the correlation between c-TET and GAT still significant if the visit interval is prolonged?

7. It is mentioned that no vision-threatening complications were observed in this study. What is the incidence of abrasions, eyelid disorder, and conjunctivitis in this study?

8. Patients with a history of incisional glaucoma surgery, LASIK, corneal surgery, or history of previously diagnosed keratoconus were not excluded in this study. How does the TET perform when measuring these patients? Is the GAT sufficiently accurate as gold standard considering these patients?

9. In line 287, the author claimed that our TET can detect the dynamic change in IOP in patients with glaucoma or ocular hypertension. However, the participants’ IOP measured by GAT all falls within the range of 22 or below. Insufficient information is available to draw the conclusion mentioned above.

10. Of eyelid tonometer TGDc-01 IOP values, 66.4% (132 eyes) within ±2 mmHg and 81.0% (161 eyes) within ±3 mmHg of those with applanation tonometry, and 10.0% (20 eyes) the deviation from applanation tonometry was more than 4 mmHg. Only 50.5% of c-TET measurements were within 2.5 mmHg of GAT measurements. What are the pros and cons of TET compared with TGDc-01?

11. What are the factors related to difference between the TET and GAT measurements? Do eyelid thickness or central corneal thickness affect difference between the TET and GAT measurements?

12. In figure 6, the label corresponding to the left fourth column may be incorrect.

13. As Kobashi designed the research, collected data, and also analysis and interpretation, How could you reduce bias and improve confidence?

Reviewer #2: It tis a interesting device for intraocular pressure measurement. There are some opinios：

1）When making aTET or GAT measurement, whether it is measured once or three times to take the average value？

2）How to consider the factors of the eyelid, whether the single eyelid or double eyelid is considered when selecting a patient？

3）The abscissa in Figure 7 is mean of c-TET and GAT, but in Figure 5 it is GAT. This is unreasonable. If Fig7 is a Bland-Altmen plot to illustrate consistency, you can provide an additional correlation plot with GAT as abscissa.

4）In Figure 7，although most of the points fall between 95% limits of agreement, the deviation from the upper and lower limits actually far exceeds the clinical approval value

5）In the study, the NCT test method was also used. It is recommended to provide the consistency analysis results of NCT and GAT as a reference to clarify the equipment needs to be improved.

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Reviewer #1: No

Reviewer #2: Yes: Xu Chen

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PONE-D-23-21962R1Evaluation of a new transpalpebral tonometer for self-measurement of intraocular pressurePLOS ONE

Dear Dr. Kobashi,

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 submit your revised manuscript by Apr 04 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,

Georgios Labiris, MD, PhD

Academic Editor

PLOS ONE

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Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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 #3: (No Response)

Reviewer #4: All comments have been addressed

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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 #3: Partly

Reviewer #4: (No Response)

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #3: Yes

Reviewer #4: (No Response)

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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 #3: Yes

Reviewer #4: (No Response)

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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 #3: No

Reviewer #4: (No Response)

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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 #3: Dear Editor,

Thank you for the opportunity to provide a review of Manuscript PONE-D-23-21962 entitled "Evaluation of a new transpalpebral tonometer for self-measurement of intraocular pressure." My comments relate primarily to the adequacy of the implementation and reporting of epidemiologic and statistical procedures.

I understand that this manuscript underwent a previous round of peer review. I have reviewed both the original and revised versions of the manuscript, including the author's response to the first-round comments.

The quality of the technical English is appropriate but variable. While offering no bar to my evaluation of the manuscript, many errors were present. I strongly recommend that the authors conduct a thorough round of copyediting to eliminate the grammatical and syntactical errors in the text.

# Reporting of correlation results

The authors state that they will report Pearson's correlation coefficient (or Spearman's). However, the authors do not report the coefficient of correlation (r) in any of the scatterplots provided, but instead report the coefficient of determination (r^2). (See Figure 4, all graphs in Figure 5, and all graphs in Figure 6.)

The authors need to clarify whether this is a labelling or calculation error. That is, did they actually calculate r^2 or did they simply label the r results as r^2. It is imperative that they DO NOT present r^2 results because the meaning of the coefficient of determination is very different from the coefficient of correlation. This is a major error that requires careful attention.

# Description of the device and the process of use

Still images are provided by the authors to describe the device and demonstrate its usage. This is substandard. The journal allows for the submission of video clips, and this is one time when such a submission is preferable to the textual and still image descriptions of the device and its use.

# Consistency of presentation of means and standard deviations

The authors state in the methods that they will present outcomes as means plus-minus standard deviations. The authors inconsistently carry this approach throughout the text. In many places, the authors report the mean (SD). The authors need to observe consistency in their reporting.

# Recommendation

The issues identified above are relatively manageable, but I cannot support the acceptance of the manuscript until they are addressed.

Thank you.

Reviewer #4: (No Response)

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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 #3: No

Reviewer #4: No

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[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.

Evaluation of a new transpalpebral tonometer for self-measuring intraocular pressure

PONE-D-23-21962R2

Dear Dr. Kobashi,

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.

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Kind regards,

Georgios Labiris, MD, PhD

Academic Editor

PLOS ONE