Perioperative pupil size in low-energy femtosecond laser-assisted cataract surgery

Alireza Mirshahi; Astrid Schneider; Catharina Latz; Katharina A. Ponto

doi:10.1371/journal.pone.0251549

Peer Review History

Original SubmissionJuly 7, 2020
10 Nov 2020 Decision Letter - Yu-Chi Liu, Editor PONE-D-20-21038 Perioperative pupil size in low-energy femtosecond laser-assisted cataract surgery PLOS ONE Dear Dr. Mirshahi, 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 Dec 25 2020 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. 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Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: [AM is a consultant to Ziemer Ophthalmics, Biel, Switzerland Yes: Ziemer assisted in extraction of pictures from the femtosecond laser device.] Additionally, because some of your funding information pertains to commercial funding, we ask you to provide an updated Competing Interests statement, declaring all sources of commercial funding. In your Competing Interests statement, please confirm that your commercial funding does not alter your adherence to PLOS ONE Editorial policies and criteria by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests. 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Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests [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: Yes ****** 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: Overall, this is a nice study with a thoughtful and well-researched discussion that contributes to our understanding of the effects of femtosecond laser technology for cataract surgery on pupillary dynamics. Most of my comments here pertain to style and grammatical suggestions. Line 59-60: Do the authors mean that they generally did not observe pupillary miosis in their experience prior to conducting this study? The way in which it is worded makes it sound almost like a conclusion of the study rather than a reason to perform the study. Line 149: Perhaps this can be phrased as “A secondary question was whether the values measured during different steps of the laser pretreatment varied from the initial values.” Line 168: Should be “The mean (±SD), median, minimum[…]” Line 176: “Change in pupil diameters at different time points{…}” Line 197-200: Awkward phrasing and grammar. Line 216: “in contrast to” may be a better phrase than “contradictory to”. Line 217: I think it would help to specify that this was a study with low energy FLACS. Line 222-224: Awkward phrasing. Line 228-229: May be better to word this as “[…]and increased amounts have been measured in FLACS compared to classic phacoemulsification[…]”. Line 231: “femtolaser” is nonstandard. Should say “femtosecond laser” or abbreviate all instances of “femtosecond laser” to something like “FSL”. This also occurs in Line 346. Line 235: I suggest “NSAID pretreatment does not appear to completely eliminate FLACS-induced miosis.” Line 245: Use of “femto” is nonstandard. See above. Line 295: References to studies with multiple authors should be written with “et al”, as in “in a 2019 study by Liu et al.” This error occurs several times. Lines 298-302: I believe all these statements are referring to the study by Liu et al., but it becomes less clear with each sentence. I suggest “They observed that preoperative administration of NSAIDS[…]” and “Additionally, oxidative stress induced[…]”, assuming this is what the authors mean. Line 322-323: This seems like an orphaned sentence. Explanation and sources should be provided for this statement. Other comments: I personally do not routinely administer peribulbar anesthesia for my cataract surgeries, preferring topical anesthesia especially with my FLACS cases. I wonder if the authors in their discussion can comment further on what extent they believe peribulbar anesthesia could have been a contributing factor in their observations if at all. Reviewer #2: Line 41: Please reword FLACS has become Staple of modern cataract surgery. There is no evidence FLACS is superior to standard phaco with regards to any clinical outcomes Line 168: Please report this is a less confusing way Mean (SD), median, and range Line 115: Peribulbar anesthesia ? May be good to state exactly volume and needle used to administer this Most cataract surgeries in U.S. are done under topical so this study would not be relevant. Authors should mention what percent of cases done with block in Germany If majority are not under topical, this study is not relevant given the block is likely the only reason constriction was not seen. ****** 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: No 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. 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Revision 1
13 Jan 2021 Author Response We have followed all suggestions by the two reviewers as follows: Reviewer #1: Overall, this is a nice study with a thoughtful and well-researched discussion that contributes to our understanding of the effects of femtosecond laser technology for cataract surgery on pupillary dynamics. Most of my comments here pertain to style and grammatical suggestions. 1. Line 59-60: Do the authors mean that they generally did not observe pupillary miosis in their experience prior to conducting this study? The way in which it is worded makes it sound almost like a conclusion of the study rather than a reason to perform the study. � Thank you for this comment. We changed the sentence to “However, according to our personal experience in the clinic we hypothesized that no miosis induction through laser pretreatment occurs when using the Ziemer Z8 laser platform.” 2. Line 149: Perhaps this can be phrased as “A secondary question was whether the values measured during different steps of the laser pretreatment varied from the initial values.” � The sentence was changed as proposed. 3. Line 168: Should be “The mean (±SD), median, minimum[…]” � We changed this as proposed. 4. Line 176: “Change in pupil diameters at different time points{…}” � The sentence was corrected accordingly. 5. Line 197-200: Awkward phrasing and grammar. � The sentence was changed to “We could not detect any equivalence of the preoperative pupil diameters to those measured immediately after application of suction, after completion of lens fragmentation, or after completion of laser capsulotomy (suction applied during those measurements, TOST procedure, all p>0.05).” 6. Line 216: “in contrast to” may be a better phrase than “contradictory to”. � We changed it as proposed. 7. Line 217: I think it would help to specify that this was a study with low energy FLACS. � We added this. 8. Line 222-224: Awkward phrasing. � The sentence was changed to “This is a physiologic phenomenon which is explained both by the afferent pupillary defect and also by an impairment in the iris sphincter (due to an intraocular pressure elevation greater than the systolic ophthalmic artery pressure)” 9. Line 228-229: May be better to word this as “[…]and increased amounts have been measured in FLACS compared to classic phacoemulsification[…]”. � We changed the sentence as proposed. 10. Line 231: “femtolaser” is nonstandard. Should say “femtosecond laser” or abbreviate all instances of “femtosecond laser” to something like “FSL”. This also occurs in Line 346. � We replaced “femtolaser” by “femtosecond laser” throughout the manuscript. 11. Line 235: I suggest “NSAID pretreatment does not appear to completely eliminate FLACS-induced miosis.” � We changed the sentence as proposed. 12. Line 245: Use of “femto” is nonstandard. See above. � We changed this throughout the paper. 13. Line 295: References to studies with multiple authors should be written with “et al”, as in “in a 2019 study by Liu et al.” This error occurs several times. � We corrected this throughout the manuscript. 14. Lines 298-302: I believe all these statements are referring to the study by Liu et al., but it becomes less clear with each sentence. I suggest “They observed that preoperative administration of NSAIDS[…]” and “Additionally, oxidative stress induced[…]”, assuming this is what the authors mean. � The sentences were revised as proposed. 15. Line 322-323: This seems like an orphaned sentence. Explanation and sources should be provided for this statement. � The sentence referred to the sentence one line above. In fact, however, the wording was awkward. We therefore reworded the sentence to better reflect the reference to the study. 16. Other comments: I personally do not routinely administer peribulbar anesthesia for my cataract surgeries, preferring topical anesthesia especially with my FLACS cases. I wonder if the authors in their discussion can comment further on what extent they believe peribulbar anesthesia could have been a contributing factor in their observations if at all. � We added the following paragraph to the discussion: “One further limitation of the present study is that all study measurements were done under peribulbar anesthesia (as it is performed in 46% of the cataract surgeries in Germany; according to a survey of 2019 by the German Society of Intraocular Implants and Refractive Surgery, DGII […]). We do not believe that the results would have been different under other anesthesia methods (incl. topical); However, further studies using other anesthesia methods are necessary to confirm the assumed.” (lines 338-344) 17. Reviewer #2: Line 41: Please reword FLACS has become Staple of modern cataract surgery. There is no evidence FLACS is superior to standard phaco with regards to any clinical outcomes � We changed the sentence to: “During the past decade, femtosecond laser-assisted cataract surgery (FLACS) has gained increasing popularity” 18. Line 168: Please report this is a less confusing way; Mean (SD), median, and range � This has been changed (see #3). 19. Line 115: Peribulbar anesthesia ? May be good to state exactly volume and needle used to administer this. � We added the details (ieach 3 ml of Mepivacaine 2% and Bupivacaine 0.75% and 75 IE hyaluronidase with a 22 Gauge needle). Lines 116-118 20. Most cataract surgeries in U.S. are done under topical so this study would not be relevant. Authors should mention what percent of cases done with block in Germany If majority are not under topical, this study is not relevant given the block is likely the only reason constriction was not seen. � We added the following paragraph to the discussion: “One further limitation of the present study is that all study measurements were done under peribulbar anesthesia (as it is performed in 46% of the cataract surgeries in Germany; according to a survey of 2019 by the German Society of Intraocular Implants and Refractive Surgery, DGII […]). We do not believe that the results would have been different under other anesthesia methods (incl. topical); However, further studies using other anesthesia methods are necessary to confirm the assumed.” (lines 338-344) https://doi.org/10.1371/journal.pone.0251549.r002
16 Feb 2021 Decision Letter - Yu-Chi Liu, Editor PONE-D-20-21038R1 Perioperative pupil size in low-energy femtosecond laser-assisted cataract surgery PLOS ONE Dear Dr. Mirshahi, Thank you for submitting your manuscript to PLOS ONE. The reviewers have raised some more comments. 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 02 2021 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Yu-Chi Liu, MD, MCI 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: All comments have been addressed 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 #1: Yes Reviewer #2: No ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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 #1: Yes 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 #1: Yes 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 #1: Additional minor recommendations and comments: Line 253: “Although all three laser platforms […]” can be the start of a new paragraph. Line 293: If subjects were given a dose of NSAID before surgery, I’m not sure how it can be concluded that the decrease in inflammatory reaction results from the use of lower pulse energy FSL and not from the use of pre-operative NSAIDs. Authors should confirm whether this was in fact a conclusion of the cited study and/or clarify this statement. Line 323-324: This is still an orphaned sentence and does not appear to have been modified from the original. I’m uncertain as to its relevance, but it can probably be incorporated into another paragraph earlier in the manuscript if you choose to keep it. Line 342: There is no reason to abbreviate “including”. The semicolon should be a period. Lines 339-343: I would advise caution with this broad assumption as it seems to directly contradict your statement on the pupillary effects of peribulbar anesthesia in Lines 306-308. Reviewer #2: It is not accurate to say peribulbar anesthesia does not affect pupil size. This is a fatal flaw of the manuscript. If 46% of cases in Germany done under peribulbar, then you should review the results of topical as well. Not sure why those with topical anesthesia were excluded from the study. https://pubmed.ncbi.nlm.nih.gov/23879851/ https://bjo.bmj.com/content/bjophthalmol/78/1/41.full.pdf ****** 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 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.0251549.r003
Revision 2
22 Mar 2021 Author Response Response to Reviewers Reviewer #1: Additional minor recommendations and comments: Line 253: “Although all three laser platforms […]” can be the start of a new paragraph. --> A new paragraph was included as recommended. Line 293: If subjects were given a dose of NSAID before surgery, I’m not sure how it can be concluded that the decrease in inflammatory reaction results from the use of lower pulse energy FSL and not from the use of pre-operative NSAIDs. Authors should confirm whether this was in fact a conclusion of the cited study and/or clarify this statement. --> As stated in the section “surgical technique” no NSAID was given to any patient before surgery in our study. --> With regards to Schwarzenbacher’s paper we acknowledge the anti-inflammatory effect of preoperative NSAID; We believe the authors’ conclusion is based on the fact that the measured inflammatory cytokine levels were lower than reported in other studies using other laser platforms. Our wording is exactly the conclusion of the cited study. Nevertheless, we added this issue to the discussion (Line 296-297) Line 323-324: This is still an orphaned sentence and does not appear to have been modified from the original. I’m uncertain as to its relevance, but it can probably be incorporated into another paragraph earlier in the manuscript if you choose to keep it. --> The sentence was deleted. Line 342: There is no reason to abbreviate “including”. The semicolon should be a period. -->The changes were made as recommended. Lines 339-343: I would advise caution with this broad assumption as it seems to directly contradict your statement on the pupillary effects of peribulbar anesthesia in Lines 306-308. --> We revised the wording and hope it is more suitable now. Lines 342-346 Reviewer #2: It is not accurate to say peribulbar anesthesia does not affect pupil size. This is a fatal flaw of the manuscript. If 46% of cases in Germany done under peribulbar, then you should review the results of topical as well. Not sure why those with topical anesthesia were excluded from the study. The authors do not claim peribulbar anesthesia does not affect the pupil size. We just believe the results of our study would have been similar under other anesthetic methods. Nevertheless, we revised the wording and hope it is more suitable (Lines 342-346). The authors perform almost all cataract surgeries under peribulbar anesthesia, thus the paper is solely representing those cases. Attachments Attachment Submitted filename: R2_Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0251549.r004
29 Apr 2021 Decision Letter - Yu-Chi Liu, Editor Perioperative pupil size in low-energy femtosecond laser-assisted cataract surgery PONE-D-20-21038R2 Dear Dr. Mirshahi, 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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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, Yu-Chi Liu, M.D 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: Comments addressed. I have stated the limitations. In the U.S. most cataract cases are performed under topical, so I think studying this in topical cases would be more helpful. ****** 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.0251549.r005
Formally Accepted
7 May 2021 Acceptance Letter - Yu-Chi Liu, Editor PONE-D-20-21038R2 Perioperative pupil size in low-energy femtosecond laser-assisted cataract surgery Dear Dr. Mirshahi: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. 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 plosone@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 Dr. Yu-Chi Liu Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0251549.r006

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