PONE-D-24-26994Efficacy of defocus incorporated multiple segments (DIMS) lens es and low-dose atropine on retarding myopic shift among premyopic preschoolers: Protocol for a prospective, multicenter, randomized controlled trialPLOS ONE

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PLOS ONE

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Additional Editor Comments:

Thank you for your submission - please address the comments from reviewer #1. In particular, consider applying a repeated measures ANOVA to these data as suggested. If you choose not to do so, please thoroughly explain the logic in your statistical approach.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: In this study protocol, a three-arm randomized control trial is being proposed to evaluate the efficacy of optical and pharmacological interventions in preventing myopia among premyopic preschoolers. The primary outcome is the mean change in cycloplegic spherical equivalent (SE). Secondary outcomes include the cumulative percentage of incident myopia, the cumulative percentage of a fast myopic shift of SE, and the changes in mean axial length.

Minor revisions:

1- Line 180: If block randomization will be used, indicate the block size.

2- Line 345: State the statistical testing method which achieves 80% power.

3- Statistical analysis (lines 356-366:) Repeated measures ANOVAs, testing the interactions of time by treatment effect, would be superior to standard ANOVAs and independent t-tests due to repeated testing.

4- Identify the software that will be used for statistical analysis.

Reviewer #2: Dear authors,

You presented a well designed protocol in order to assess the effect of DIMS and low dose atropine on myopic evolution. Overall, the sections of the protocol were clearly explained, along with the endpoints and the statistical methods you will employ. I have no specific complaints regarding the protocol, which appears detailed and complete. Good luck for your trial.

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Reviewer #1: No

Reviewer #2: No

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Efficacy of defocus incorporated multiple segments (DIMS) lens es and low-dose atropine on retarding myopic shift among premyopic preschoolers: Protocol for a prospective, multicenter, randomized controlled trial

PONE-D-24-26994R1

Dear Dr. Tsai,

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,

Nick Fogt

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for addressing the reviewer comments. This paper is ready to move on to the publication phase.

Reviewers' comments: