CONSORT Compliance of Phacoemulsification Randomised Controlled Trials: A Systematic Review

CONSORT Compliance of Phacoemulsification Randomised Controlled Trials: A Systematic Review | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article CONSORT Compliance of Phacoemulsification Randomised Controlled Trials: A Systematic Review Michael Milad, Sebastian Mitchell, Kian Daneshi, Omar Farooq, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7190088/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Phacoemulsification surgery constitutes a large proportion of Ophthalmic procedures and continues to evolve rapidly. However, poor reporting in randomised controlled trials (RCTs) can impede interpretation and application of findings. The Consolidated Standards of Reporting Trials - Non-pharmacological Treatments (CONSORT-NPT) guidelines aim to improve transparency, but adherence in phacoemulsification RCTs remains unclear. Methods A systematic review was conducted according to PRISMA and AMSTAR-2 standards. Five databases were searched for phacoemulsification RCTs published between January 2023 and December 2024. Studies were assessed using the 25-item CONSORT-NPT checklist. Data on study characteristics (number of authors, journal impact factor, number of eyes, study designs) were extracted. Relationships between CONSORT scores and study characteristics were analysed using Spearman’s rank correlation and unpaired t-tests. Study quality was assessed using the Cochrane Risk of Bias tool and GRADE framework. Results Twenty-five RCTs met the inclusion criteria. The mean CONSORT compliance score was 68.6% (range: 40.0–83.8%). Complete adherence was seen in reporting trial design, eligibility, and statistical methods, but none adequately reported implementation fidelity or protocol deviations for bias mitigation when blinding was not possible. A weak but statistically significant positive correlation existed between journal impact factor and CONSORT compliance (R² = 0.190, p = 0.0269). No significant difference was found between studies published in 2023 and 2024 (p = 0.137). Risk of bias was low or moderate; methodological quality was rated moderate or high via GRADE. Conclusions Reporting quality is moderate, with critical gaps in methodological transparency. Emphasising full adherence to CONSORT-NPT is essential to improve the quality, reproducibility, and clinical relevance of phacoemulsification research. Biological sciences/Neuroscience/Visual system Health sciences/Medical research/Outcomes research Phacoemulsification CONSORT RCTs Compliance Non-pharmaceutical Trials Surgery Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction Phacoemulsification is the most commonly performed cataract surgery worldwide, with an estimated 28 million procedures carried out annually, a number that continues to rise with aging populations and improved global access to eye care [1–3]. This microsurgical technique has undergone continual refinement, with advances in instrumentation, intraocular lens technology, and perioperative protocols significantly enhancing outcomes. As these innovations reshape clinical practice, robust evidence from randomised controlled trials (RCTs) remains essential for evaluating their safety, efficacy, and broader applicability. However, even rigorously designed RCTs may fail to achieve their intended impact if methodological and procedural details are inadequately reported. Insufficient reporting impairs reproducibility, limits critical appraisal, and ultimately hinders the translation of research into clinical care [4–6]. To address these challenges, the Consolidated Standards of Reporting Trials (CONSORT) guidelines were introduced to standardise the reporting of RCTs, improving transparency and enabling consistent interpretation of study findings [7]. Surgical research, including studies in ophthalmology, presents unique complexities—such as operator-dependent variability, evolving technologies, and multifaceted interventions—that make comprehensive reporting particularly crucial [8–10]. Although initiatives like the IDEAL framework have underscored the importance of structured evaluation in surgical innovation [11], the degree to which RCTs in phacoemulsification surgery adhere to such reporting standards remains unclear. The 2017 CONSORT extension for nonpharmacologic treatments (CONSORT-NPT) further emphasises the need for detailed, context-specific reporting in surgical trials, yet its uptake and application in ophthalmic research have not been systematically assessed [12,13]. This systematic review will evaluate the extent to which RCTs in phacoemulsification surgery adhere to CONSORT-NPT standards, with the aim of promoting clear, complete, and methodologically sound reporting. Adherence to these standards enhances the credibility, reproducibility, and clinical relevance of research findings, ultimately supporting evidence-based decision-making. By characterising current reporting practices and identifying areas for improvement, this review will help to strengthen the quality and translational value of future research in phacoemulsification surgery. Improved compliance with established reporting guidelines is essential for advancing patient care in this dynamic and rapidly evolving field. Methods This systematic review followed the guidance outlined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and AMSTAR-2 [14,15]. We conducted a comprehensive literature search to identify relevant studies. The review methods were established prior to the conduction of the review. Selection The inclusion criteria focused on RCTs related to phacoemulsification procedures which were published in peer-reviewed journals between January 2023 and December 2024. Eligible studies included a phacoemulsification intervention in human eyes undergoing at least once procedure. The primary outcome was the degree of adherence to the updated CONSORT-NPT guidelines. Exclusion criteria included: non-randomised studies; non-English articles; studies limited to pharmacological therapies with no surgical/procedural component; studies published outside of the dates of 01/01/2023 and 12/12/2024. This approach ensured that only RCTs which addressed phacoemulsification and reporting standards were included in the systematic review. Search A comprehensive literature search was carried out to identify studies published between January 2023 and December 2024. Searches were performed across PubMed (National Center for Biotechnology Information, U.S. National Library of Medicine, Bethesda, MD, USA), Medline (National Institutes of Health, Bethesda, MD), Embase (National Institutes of Health, Bethesda, MD), Web of Science (Clarivate, Philadelphia, PA, USA) and Cochrane Central Register of Controlled Trials (CENTRAL; Wiley, Hoboken, NJ). The search strategy adhered to the Peer Review of Electronic Search Strategies (PRESS) guidance [16]. Terms used included “randomised controlled trials”, “Ophthalmological Surgical Procedures” and “cataract surgery”. We used Medical Subject Headings (MeSH), truncations and Boolean operators to maximise retrieval of relevant articles. The search strategy was refined by a university librarian to maximise the retrieval of any relevant articles. The full search strategy is provided in Supplementary Digital Content 1. [Supplementary Digital Content 1: Search strategy] Study Selection All articles which were retrieved were exported to Rayyan (version 3.0) for deduplication and screening. Two reviewers (O.F. and A.H.) screened the titles and abstracts independently to determine their eligibility. Full-text articles of potentially relevant studies were then assessed in a second round. Any discrepancies following this were resolved through a discussion with a third reviewer until consensus was reached. Data Collection and Analysis Data from the included studies were extracted by four reviewers (A.H, S.P, M.M, S.K.) using a standardised data extraction form on Microsoft Excel (version 16.54). We collected the following variables: study details (article name, author, journal that the article is published in, publication date, geographical origin of the authors, year that article was published in, impact factor of the journal, whether studies were single/multi-centre, participants’ demographics (the number of eyes in each RCT). Each study which was included was evaluated against the updated 25-item CONSORT NPT checklist [10]. Items with multiple components were assessed so that each sub-component was evaluated separately. Compliance for individual checklist items were expressed as the proportion of studies meeting each of the criteria. In order to explore potential correlations, the overall CONSORT scores were analysed in relation to the year of publication, the number of authors, the journal’s impact factor, and the number of eyes in each of the studies. A secondary reviewer independently validated the scoring, with disagreements resolved through consensus, or referral to the lead author. The relationship between the CONSORT score and each outcome will be assessed using Spearman’s rank correlation coefficient. Unpaired t-test will be used to compare the mean CONSORT compliance score of papers published in 2023 and 2024. Descriptive statistics were used to summarise compliance trends and highlight common deficiencies in reporting. Further Critical Appraisal We evaluated the risk of bias of the included studies using the Cochrane Risk of Bias 2.0 tool (ROB) [17]. Results were summarised in a tabular form to provide an overview of each study’s methodological strengths and limitations. Any discrepancies were resolved through discussion. If discrepancies remained, this was referred to the lead author (M.M.). The overall quality of evidence was then further assessed using the Grading of Recommendations, Assessment, Development and Evaluation framework [18]. Results Systematic Search and Study Selection The initial database search yielded 5488 records, after which 2036 duplicates were excluded, leaving 3452 for abstract screening. Title and abstract screening excluded 3048 studies, which narrowed the selection to 404 articles for full-text screening. Of these, 379 articles were excluded. The final number of studies that met full inclusion criteria for extraction was 25. No additional eligible studies were identified via hand searching or snowballing. Figure 1 illustrates the selection process. Due to the number of included studies, references of the 25 studies can be found in Supplemental Digital File 2. [Supplementary Digital Content 2 - References of the 25 included studies.] Summary of Included Phacoemulsification RCTs There were more studies published in 2024 (n = 17, 68.%) than 2023 (n = 8, 32.%). India was the most common country of origin of the authors (n = 10, 40%). Most studies were published in journals with an impact factor of 1–3 (n = 15, 60%). Most studies included multiple authors, with three-author collaborations being the most common (n = 6, 24%). The mean number of eyes included in the studies was 95.7 (SD = 61.3, 95% CI: 37.3–85.3), with most studies including 100 eyes or more (n = 14, 56%). All but one study was carried out in a single-centre (n = 24, 96%). [Supplementary Digital Content 3 - Study Characteristics of the included studies] Summary of Percentage Adherence to CONSORT Checklist Criteria The primary outcome was to assess compliance of phacoemulsification RCTs to CONSORT-NPT guidelines. This is summarized in table 1. The mean compliance score was 68.6% (SD = 11.7%, 95% CI: 63.8–73.4). The best complying study scored 83.8%, whilst the least complying study scored 40%. All studies correctly identified the type of study and scientific rationale. Other sections scoring 100% adherence were stating eligibility criteria; statistical methods used to interpret results, effect sizes as well as providing conclusions balancing benefits and harms whilst considering other relevant evidence. No studies provided details on whether and how care providers adhered to protocols; whether there had been any changes to the methodology after trial commencement; and methods used to limit bias if blinding was not possible. Relationship between CONSORT compliance score and Journal Impact Factor Figure 2 portrays individual study compliance to each journal’s impact factor. There is a weakly positive but statistically significant relationship between journals with higher impact factor and the percentage compliance to CONSORT guidelines (R2 = 0.190, p-value = 0.0269). Relationship between CONSORT Adherence and Number of Authors Figure 3 portrays compliance to the CONSORT checklist relative to the number of authors per study. There is no statistically significant correlation observed between percentage compliance to CONSORT guidelines and number of authors (R2 = 0.05, p value = 0.215) Relationship between CONSORT adherence scores and number of eyes assessed Figure 4 portrays the relationship between the number of eyes assessed in each study and the corresponding CONSORT score. There is no statistically significant correlation between the number of eyes assessed and the CONSORT adherence scores (R2 = 0.01, p = 0.638). Difference in reporting quality between papers published in 2023 vs 2024 There was no statistically significant difference in the adherence to the CONSORT guidelines between papers published in 2023 and those published in 2024 (mean 73.69 vs 66.2, p = 0.137). This can be found in Supplementary Digital Content 4. [Supplementary Digital Content 4 - Percentage compliance to CONSORT in 2023 vs 2024] RoB Assessment A RoB assessment found all to have low or moderate RoB, with no consistent high-risk concerns (Supplementary Digital Content 5). This suggests that authors have taken steps to minimise bias across phacoemulsification studies. [Supplementary Digital Content 5 - RoB assessment of studies] GRADE Assessment A GRADE quality assessment classified most studies as being of high or moderate quality (Supplementary Digital Content 6). Two papers were marked as being of low quality. There were no consistent concerns amongst any of the domains. Since the focus of this study is reporting quality, rather than internal validity of the papers, no studies were excluded due to their RoB or GRADE assessments. [Supplementary Digital Content 6 - GRADE assessment of studies] AMSTAR-2 Assessment We evaluated previous systematic reviews using AMSTAR-2, identifying several critical flaws (Supplementary Digital Content 7). We also carried out a self-assessment AMSTAR-2, which identified no critical flaws. [Supplementary Digital Content 7 - AMSTAR-2 assessment of studies] Discussion This systematic review provides the first, comprehensive assessment of adherence to the CONSORT-NPT criteria of phacoemulsification RCTs published. The review identified that overall adherence to the CONSORT-NPT checklist was slightly more than two-thirds across all included studies. This level of compliance suggests a moderate commitment to the CONSORT-NPT. It is encouraging that essential methodological elements, such as trial design, sample size determination and data analysis, were reported well. However, lower adherence to sections involving implementation fidelity and post-randomisation procedures underlies the continued need to enhance transparency, especially in the conduct and practical delivery of surgical interventions. Despite this, assessment using GRADE classified most studies as being of moderate or high quality, and the Cochrane RoB tool indicated that all studies had a low or moderate RoB. There were no concerns which were consistent across the studies, which reinforced the reliability of the trials. Overall, compliance in Phacoemulsification surgery to CONSORT guidelines is similar to that in other surgical RCTs. For example, Liu et al., reported on bariatric surgery, noting that the median compliance score was 63.3%, but just 26.8% when the NPT extension items were assessed [ 19 ]. Similarly, Huang et al., noted a mean compliance of 59% of research papers published in otolaryngology [ 20 ]. These findings suggest that whilst reporting is universally adequate, there remains significant room for improvement. There was a weak but statistically significant correlation between journal impact factor and CONSORT checklist compliance (R² = 0.19, p = 0.0269). This may suggest that publications in higher-impact journals could be associated with more rigorous reporting standards, hence reflecting the stricter editorial policies. However, the magnitude of the correlation indicates that other factors could account for variations in reporting quality, rather than impact factor alone. There was no correlation between CONSORT adherence and the number of eyes within the study (R² = 0.01, p = 0.638), or the number of authors in the study (R² = 0.05, p = 0.215). Whilst larger teams may be expected to have more comprehensive trial reporting, our findings suggest that the number of authors alone does not predict reporting quality. Similarly, there was no statistical difference in CONSORT adherence between papers published in 2023 and those published in 2024 (mean 73.69 vs 66.2, p = 0.137). Importantly, there were no studies which adequately reported the methods used to ensure care provider adherence or described any deviations from trial methodology after initiation. These are core aspects of interval validity that are especially critical in surgical RCTs, where interventions are often highly operator dependent [ 21 ]. Furthermore, despite the inherent challenges around blinding in surgical contexts, no studies discussed alternative strategies for minimising performance and detecting bias when blinding was not possible. This reinforces calls from previous studies for greater incorporation of practical strategies in order to mitigate unblinded trials [ 22 , 23 ]. All but one study was carried out in a single centre, which can further complicate CONSORT adherence in phacoemulsification RCTs. Single-centre trials can lack the generalisability of multicentre studies, which is essential in externally validating research findings [ 24 ]. Furthermore, the smaller sample sizes result in reduced statistical power, consequently this can increase the risk of Type I and Type II errors [ 25 ]. By encouraging collaboration between institutions, larger, well-powered studies can be carried out, which is essential in improving methodological rigor and adherence to CONSORT standards. Establishing multicentre collaboration could also promote greater adherence to reporting guidelines, as there will be more shared best practices and resources [ 26 ]. In addition to this, studies with alternative designs, such as pragmatic and real-world trials, can overcome some of the limitations of RCT, hence enhancing generalizability and patient recruitment in surgical research [ 27 ]. Notably, a large proportion of studies were carried out in India (n = 10, 40%). This could be due to the prevalence of cataracts in India, and hence the large surgical volume [ 28 ]. However, it is important to note that this geographic skew in the data raises concerns regarding its generalisability: healthcare infrastructures and patient populations will be markedly different across regions. Areas for improvement The findings from our review suggest that there are specific CONSORT-NPT checklist items which remain under-reported, and so require greater attention from authors, reviewers and editors. In particular, there is a lack of information on: care providers adhering to protocols; modifications to methods after trial commencement; why trials were ended/stopped; and strategies used when blinding is not possible. This seems to be keeping in line with the general literature, which indicates that many trials fail to report critical methodological details, which can significantly impact the validity of their results [ 29 ]. Whilst most papers mentioned the potential harms or unintended side effects of interventions (n = 18 studies, 72.%), there is still room for improvement. This is a particularly important area to report on, since complications in phacoemulsification surgery can have a significant impact on outcomes and overall patient satisfaction. The CONSORT extension for Harms Checklist is a valuable framework, which can be used to provide more consistent and transparent reporting of complications or adverse events. It is essential that studies adhere to this extension, given the inherent risks of phacoemulsification, such as endophthalmitis [ 30 ]. These areas represent key missed opportunities to enhance the transparency and the reproducibility of RCT studies. These components are especially vital in studies where operator skill, procedural fidelity and intra-operative variability can significantly impact the outcomes of studies. Furthermore, few studies reported whether, and how, adherence-enhancing strategies (e.g. monitoring visits, training sessions etc.) were implemented, which suggests a potential disconnect between trial protocols and real-world clinical execution. Improving reporting in this domain would allow clinicians to better interpret the feasibility, and translatability of interventions into everyday practice. Implications for Research and Clinical Practice High-quality RCTs are essential to the development of evidence-based ophthalmology. However, if research is reported incorrectly, it is difficult for clinicians to evaluate the validity of findings, or to apply the interventions confidently to their clinical practice. Our findings suggest that, whilst phacoemulsification-based surgical trials are making progress towards comprehensive reporting, there is a clear need for improvement in areas of contextual and procedural transparency. To support this, we recommend that authors use the CONSORT-NPT checklists throughout the entire trial period: to guide study design; conduct phases; and during manuscript preparation. Institutions and ethical committees should make an active effort to embed reporting standards into their monitoring frameworks and protocol templates. Journals should also enforce stricter checklist-based submission requirements and offer structured training for peer-reviewers to identify any reporting omissions. Limitations Whilst this review has several merits, it is essential to discuss potential limitations. Firstly, although we have implemented a robust systematic search strategy, it is possible that relevant studies were missed, particularly those published in non-indexed or regional journals. Secondly, the study focuses on phacoemulsification procedures, which may limit the generalisability of our findings to other Ophthalmic surgeries. Thirdly, whilst our scoring system enables a granular assessment of each CONSORT-NPT item, the subjective nature of some components may introduce reviewer bias, despite our dual review and consensus resolution method. We have attempted to minimise this by having a training session to teach all reviewers how to accurately score studies, and to address any questions. Furthermore, we have only searched studies published between 2023 and 2024, hence compliance and trends outside of those years remain unreported. Conclusion This systematic review highlights that, whilst there has been substantial adherence to certain aspects of CONSORT reporting in recent phacoemulsification studies, there are significant gaps which remain. This is particularly in relation to procedural transparency and blinding methodology, which may influence adherence of studies. By strengthening RCT adherence to CONSORT-NPT guidelines, the scientific community will enhance the quality and clinical utility of phacoemulsification surgical research, hence ultimately support better patient outcomes. Declarations Funding: This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Conflict of interest: The authors declare that they have no financial or personal conflicts of interest relevant to this study. Competing interests: The authors declare there were no competing interests, and they received no grants or equipment’s for this study. 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Table Table 1 is available in the Supplementary Files section Additional Declarations There is no conflict of interest Supplementary Files 19.07.25SupplementaryDigitalContent1.docx Search strategy 19.07.25SupplementaryDigitalContent2.docx References of the 25 included studies 19.07.25SupplementaryDigitalContent3.xlsx Study Characteristics of the included studies 19.07.25SupplementaryDigitalContent4.docx Percentage compliance to CONSORT in 2023 vs 2024 19.07.25SupplementaryDigitalContent5.xlsx RoB assessment of studies 19.07.25SupplementaryDigitalContent6.xlsx GRADE assessment of studies 19.07.25SupplementaryDigitalContent7.xlsx AMSTAR-2 assessment of studies 19.7.25Table1.xlsx Compliance of phacoemulsification RCTs to CONSORT-NPT guidelines Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7190088","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":506199090,"identity":"8afe3cf4-2b64-4b0d-b957-209997d4b7a0","order_by":0,"name":"Michael Milad","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7ElEQVRIiWNgGAWjYDACZgY2IGkBZDA3MPAY2DAYEKlFAshgBGopSINqScCrCaqFAaTlw2HCWnTbmZ89+FEhAWQwNn54Y3A+z5z/ANuDjz9wazE7zGZu2HNGAshgbJacY3C72HJGArvhDDy2mB3mYZPgbQNraZDmMbiduOEGA5s0DwEtkn//QWz5zWNwLnHD+QNs0n8IaJHmbQBraQPaciBxw4EENml83gf6xUxa5pgED0iL5RyDZKDDEtske9LwaDl/+JnkmxobOSDj8I03f+yADjt8TOKHDW4tMMCDxAZG0CgYBaNgFIwCygAANThM/SSvlroAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-5654-3501","institution":"West Hertfordshire NHS Trust","correspondingAuthor":true,"prefix":"","firstName":"Michael","middleName":"","lastName":"Milad","suffix":""},{"id":506199091,"identity":"e4de2bac-b7e1-4de0-ad2a-93b073260ec0","order_by":1,"name":"Sebastian Mitchell","email":"","orcid":"https://orcid.org/0009-0006-6357-0053","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Sebastian","middleName":"","lastName":"Mitchell","suffix":""},{"id":506199092,"identity":"70c9d7aa-85b4-449e-8ebe-6a610f97b37c","order_by":2,"name":"Kian Daneshi","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Kian","middleName":"","lastName":"Daneshi","suffix":""},{"id":506199093,"identity":"5e0016de-9db7-4734-8a38-8ab7780290d8","order_by":3,"name":"Omar Farooq","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Omar","middleName":"","lastName":"Farooq","suffix":""},{"id":506199094,"identity":"5e1c36c4-3260-409d-b954-8e11eb8acc7d","order_by":4,"name":"Sreehari Pillai","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Sreehari","middleName":"","lastName":"Pillai","suffix":""},{"id":506199095,"identity":"59579368-9a1e-4083-999e-dce0f7136a4d","order_by":5,"name":"Angeline Pesala","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Angeline","middleName":"","lastName":"Pesala","suffix":""},{"id":506199096,"identity":"28159d2d-7f8c-4288-bd91-0743ee428a87","order_by":6,"name":"Sumbel Khan","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Sumbel","middleName":"","lastName":"Khan","suffix":""},{"id":506199097,"identity":"1cfb5529-0906-4291-8b31-8d094b344569","order_by":7,"name":"Aasim Hagroo","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Aasim","middleName":"","lastName":"Hagroo","suffix":""},{"id":506199098,"identity":"f8ad7186-1e71-4d65-bf27-4075bc0f9ba1","order_by":8,"name":"Raed Alderhali","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Raed","middleName":"","lastName":"Alderhali","suffix":""}],"badges":[],"createdAt":"2025-07-22 19:45:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7190088/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7190088/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90542071,"identity":"8d28b1e5-b742-47cf-a2e0-d5af44442297","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":27595,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePRISMA 2020 flow diagram for new systematic reviews which included searches of databases and registers only\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e*Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers).\u003c/p\u003e\n\u003cp\u003e**If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools.\u003c/p\u003e\n\u003cp\u003eSource: Page MJ, et al. BMJ 2021;372:n71. doi: 10.1136/bmj.n71.\u003c/p\u003e\n\u003cp\u003eThis work is licensed under CC BY 4.0. To view a copy of this license, visit \u003ca href=\"https://creativecommons.org/licenses/by/4.0/\"\u003ehttps://creativecommons.org/licenses/by/4.0/\u003c/a\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/780392d5a49bb41e5be3d352.png"},{"id":90542707,"identity":"0f93808b-6e5f-4e74-ab62-977fe52bc5a1","added_by":"auto","created_at":"2025-09-04 00:07:45","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":54424,"visible":true,"origin":"","legend":"\u003cp\u003eScatter plot illustrating the relationship between journal impact factor and percentage compliance with CONSORT-NPT guidelines among included phacoemulsification RCTs.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/645ad1140bdf882a8c883a7c.png"},{"id":90542075,"identity":"e70147b7-1e7c-4b36-83ac-c6d164165e87","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":47160,"visible":true,"origin":"","legend":"\u003cp\u003eScatter plot displaying the percentage compliance with CONSORT-NPT reporting standards in relation to the number of authors involved in each study.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/e0dfc1c45752ec70758dd84d.png"},{"id":90544152,"identity":"7482b9cb-4dab-4754-9b9c-825d7caf556f","added_by":"auto","created_at":"2025-09-04 00:15:45","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":51781,"visible":true,"origin":"","legend":"\u003cp\u003eScatter plot showing the association between the number of eyes assessed in each RCT and the corresponding CONSORT-NPT compliance score.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/b61473e6bc50ec0433dd0d33.png"},{"id":93040951,"identity":"1ca83874-5b65-404d-888f-271dab17d7cf","added_by":"auto","created_at":"2025-10-08 12:12:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1057728,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/8ce8b85f-594c-4bdb-bb11-00bf3185e45c.pdf"},{"id":90542070,"identity":"29c477f7-8d1e-48bf-b25d-b0589d38282e","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":15896,"visible":true,"origin":"","legend":"Search strategy","description":"","filename":"19.07.25SupplementaryDigitalContent1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/f6a701273030d1e7ee3f5a1d.docx"},{"id":90542082,"identity":"3a487c9d-40bf-4d0d-b3d2-efd81e324020","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":2499564,"visible":true,"origin":"","legend":"References of the 25 included studies","description":"","filename":"19.07.25SupplementaryDigitalContent2.docx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/05efee50f2b7fc87f580a2f8.docx"},{"id":90542084,"identity":"d2087e44-7cd7-4004-a0e1-06ba0483beeb","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"xlsx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":74952,"visible":true,"origin":"","legend":"Study Characteristics of the included studies","description":"","filename":"19.07.25SupplementaryDigitalContent3.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/8995228ef9d433660d1e5721.xlsx"},{"id":90542076,"identity":"0cb3db73-12ec-4a4b-89fc-66d6ccd3f60b","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":65089,"visible":true,"origin":"","legend":"Percentage compliance to CONSORT in 2023 vs 2024","description":"","filename":"19.07.25SupplementaryDigitalContent4.docx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/85fc0b69b9cd7ef0db4d1564.docx"},{"id":90542711,"identity":"6ec29ec2-060b-4b8a-a275-6f8520b1bde8","added_by":"auto","created_at":"2025-09-04 00:07:45","extension":"xlsx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":11285,"visible":true,"origin":"","legend":"\u003cp\u003eRoB assessment of studies\u003c/p\u003e","description":"","filename":"19.07.25SupplementaryDigitalContent5.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/351b8bf71a41c3eb32962843.xlsx"},{"id":90542103,"identity":"e6a5527b-6d1b-433d-9395-0f7e34deb892","added_by":"auto","created_at":"2025-09-03 23:59:46","extension":"xlsx","order_by":6,"title":"","display":"","copyAsset":false,"role":"supplement","size":11553,"visible":true,"origin":"","legend":"\u003cp\u003eGRADE assessment of studies\u003c/p\u003e","description":"","filename":"19.07.25SupplementaryDigitalContent6.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/af0e1fefc7f2e12776ab672a.xlsx"},{"id":90542092,"identity":"933243ef-eb34-480f-ac9e-9c1d99338a40","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"xlsx","order_by":7,"title":"","display":"","copyAsset":false,"role":"supplement","size":9740,"visible":true,"origin":"","legend":"\u003cp\u003eAMSTAR-2 assessment of studies\u003c/p\u003e","description":"","filename":"19.07.25SupplementaryDigitalContent7.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/93ff13a5231ea81bf69c25e5.xlsx"},{"id":90542078,"identity":"770d15ab-ef5c-4000-8771-c3c81fd7d3d9","added_by":"auto","created_at":"2025-09-03 23:59:45","extension":"xlsx","order_by":8,"title":"","display":"","copyAsset":false,"role":"supplement","size":14498,"visible":true,"origin":"","legend":"\u003cp\u003eCompliance of phacoemulsification RCTs to CONSORT-NPT guidelines\u003c/p\u003e","description":"","filename":"19.7.25Table1.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-7190088/v1/c847602ae48a5073350ea09d.xlsx"}],"financialInterests":"There is no conflict of interest","formattedTitle":"CONSORT Compliance of Phacoemulsification Randomised Controlled Trials: A Systematic Review","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePhacoemulsification is the most commonly performed cataract surgery worldwide, with an estimated 28 million procedures carried out annually, a number that continues to rise with aging populations and improved global access to eye care [1–3]. This microsurgical technique has undergone continual refinement, with advances in instrumentation, intraocular lens technology, and perioperative protocols significantly enhancing outcomes. As these innovations reshape clinical practice, robust evidence from randomised controlled trials (RCTs) remains essential for evaluating their safety, efficacy, and broader applicability.\u003c/p\u003e\n\u003cp\u003eHowever, even rigorously designed RCTs may fail to achieve their intended impact if methodological and procedural details are inadequately reported. Insufficient reporting impairs reproducibility, limits critical appraisal, and ultimately hinders the translation of research into clinical care [4–6]. To address these challenges, the Consolidated Standards of Reporting Trials (CONSORT) guidelines were introduced to standardise the reporting of RCTs, improving transparency and enabling consistent interpretation of study findings [7].\u003c/p\u003e\n\u003cp\u003eSurgical research, including studies in ophthalmology, presents unique complexities—such as operator-dependent variability, evolving technologies, and multifaceted interventions—that make comprehensive reporting particularly crucial [8–10]. Although initiatives like the IDEAL framework have underscored the importance of structured evaluation in surgical innovation [11], the degree to which RCTs in phacoemulsification surgery adhere to such reporting standards remains unclear. The 2017 CONSORT extension for nonpharmacologic treatments (CONSORT-NPT) further emphasises the need for detailed, context-specific reporting in surgical trials, yet its uptake and application in ophthalmic research have not been systematically assessed [12,13].\u003c/p\u003e\n\u003cp\u003eThis systematic review will evaluate the extent to which RCTs in phacoemulsification surgery adhere to CONSORT-NPT standards, with the aim of promoting clear, complete, and methodologically sound reporting. Adherence to these standards enhances the credibility, reproducibility, and clinical relevance of research findings, ultimately supporting evidence-based decision-making. By characterising current reporting practices and identifying areas for improvement, this review will help to strengthen the quality and translational value of future research in phacoemulsification surgery. Improved compliance with established reporting guidelines is essential for advancing patient care in this dynamic and rapidly evolving field.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis systematic review followed the guidance outlined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and AMSTAR-2 [14,15]. We conducted a comprehensive literature search to identify relevant studies. The review methods were established prior to the conduction of the review.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSelection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe inclusion criteria focused on RCTs related to phacoemulsification procedures which were published in peer-reviewed journals between January 2023 and December 2024. Eligible studies included a phacoemulsification intervention in human eyes undergoing at least once procedure. The primary outcome was the degree of adherence to the updated CONSORT-NPT guidelines. Exclusion criteria included: non-randomised studies; non-English articles; studies limited to pharmacological therapies with no surgical/procedural component; studies published outside of the dates of 01/01/2023 and 12/12/2024. This approach ensured that only RCTs which addressed phacoemulsification and reporting standards were included in the systematic review.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSearch\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA comprehensive literature search was carried out to identify studies published between January 2023 and December 2024. Searches were performed across PubMed (National Center for Biotechnology Information, U.S. National Library of Medicine, Bethesda, MD, USA), Medline (National Institutes of Health, Bethesda, MD), Embase (National Institutes of Health, Bethesda, MD), Web of Science (Clarivate, Philadelphia, PA, USA) and Cochrane Central Register of Controlled Trials (CENTRAL; Wiley, Hoboken, NJ). The search strategy adhered to the Peer Review of Electronic Search Strategies (PRESS) guidance [16]. Terms used included “randomised controlled trials”, “Ophthalmological Surgical Procedures” and “cataract surgery”. We used Medical Subject Headings (MeSH), truncations and Boolean operators to maximise retrieval of relevant articles. The search strategy was refined by a university librarian to maximise the retrieval of any relevant articles. The full search strategy is provided in Supplementary Digital Content 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 1: Search strategy]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Selection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll articles which were retrieved were exported to Rayyan (version 3.0) for deduplication and screening. Two reviewers (O.F. and A.H.) screened the titles and abstracts independently to determine their eligibility. Full-text articles of potentially relevant studies were then assessed in a second round. Any discrepancies following this were resolved through a discussion with a third reviewer until consensus was reached.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection and Analysis\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData from the included studies were extracted by four reviewers (A.H, S.P, M.M, S.K.) using a standardised data extraction form on Microsoft Excel (version 16.54). We collected the following variables: study details (article name, author, journal that the article is published in, publication date, geographical origin of the authors, year that article was published in, impact factor of the journal, whether studies were single/multi-centre, participants’ demographics (the number of eyes in each RCT). Each study which was included was evaluated against the updated 25-item CONSORT NPT checklist [10]. Items with multiple components were assessed so that each sub-component was evaluated separately. Compliance for individual checklist items were expressed as the proportion of studies meeting each of the criteria.\u003c/p\u003e\n\u003cp\u003eIn order to explore potential correlations, the overall CONSORT scores were analysed in relation to the year of publication, the number of authors, the journal’s impact factor, and the number of eyes in each of the studies. A secondary reviewer independently validated the scoring, with disagreements resolved through consensus, or referral to the lead author. The relationship between the CONSORT score and each outcome will be assessed using Spearman’s rank correlation coefficient. Unpaired t-test will be used to compare the mean CONSORT compliance score of papers published in 2023 and 2024. Descriptive statistics were used to summarise compliance trends and highlight common deficiencies in reporting.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFurther Critical Appraisal\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe evaluated the risk of bias of the included studies using the Cochrane Risk of Bias 2.0 tool (ROB) [17]. Results were summarised in a tabular form to provide an overview of each study’s methodological strengths and limitations. Any discrepancies were resolved through discussion. If discrepancies remained, this was referred to the lead author (M.M.). The overall quality of evidence was then further assessed using the Grading of Recommendations, Assessment, Development and Evaluation framework [18].\u0026nbsp;\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eSystematic Search and Study Selection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe initial database search yielded 5488 records, after which 2036 duplicates were excluded, leaving 3452 for abstract screening. Title and abstract screening excluded 3048 studies, which narrowed the selection to 404 articles for full-text screening. Of these, 379 articles were excluded. The final number of studies that met full inclusion criteria for extraction was 25. No additional eligible studies were identified via hand searching or snowballing. Figure 1 illustrates the selection process. Due to the number of included studies, references of the 25 studies can be found in Supplemental Digital File 2.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 2 - References of the 25 included studies.]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSummary of Included Phacoemulsification RCTs\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere were more studies published in 2024 (n\u0026thinsp;=\u0026thinsp;17, 68.%) than 2023 (n\u0026thinsp;=\u0026thinsp;8, 32.%). India was the most common country of origin of the authors (n\u0026thinsp;=\u0026thinsp;10, 40%). Most studies were published in journals with an impact factor of 1\u0026ndash;3 (n\u0026thinsp;=\u0026thinsp;15, 60%). Most studies included multiple authors, with three-author collaborations being the most common (n\u0026thinsp;=\u0026thinsp;6, 24%). The mean number of eyes included in the studies was 95.7 (SD\u0026thinsp;=\u0026thinsp;61.3, 95% CI: 37.3\u0026ndash;85.3), with most studies including 100 eyes or more (n\u0026thinsp;=\u0026thinsp;14, 56%). All but one study was carried out in a single-centre (n\u0026thinsp;=\u0026thinsp;24, 96%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 3 - Study Characteristics of the included studies]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSummary of Percentage Adherence to CONSORT Checklist Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome was to assess compliance of phacoemulsification RCTs to CONSORT-NPT guidelines. This is summarized in table 1. The mean compliance score was 68.6% (SD\u0026thinsp;=\u0026thinsp;11.7%, 95% CI: 63.8\u0026ndash;73.4). The best complying study scored 83.8%, whilst the least complying study scored 40%. All studies correctly identified the type of study and scientific rationale. Other sections scoring 100% adherence were stating eligibility criteria; statistical methods used to interpret results, effect sizes as well as providing conclusions balancing benefits and harms whilst considering other relevant evidence. No studies provided details on whether and how care providers adhered to protocols; whether there had been any changes to the methodology after trial commencement; and methods used to limit bias if blinding was not possible.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelationship between CONSORT compliance score and Journal Impact Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFigure \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e portrays individual study compliance to each journal\u0026rsquo;s impact factor. There is a weakly positive but statistically significant relationship between journals with higher impact factor and the percentage compliance to CONSORT guidelines (R2\u0026thinsp;=\u0026thinsp;0.190, p-value\u0026thinsp;=\u0026thinsp;0.0269).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelationship between CONSORT Adherence and Number of Authors\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFigure 3 portrays compliance to the CONSORT checklist relative to the number of authors per study. There is no statistically significant correlation observed between percentage compliance to CONSORT guidelines and number of authors (R2\u0026thinsp;=\u0026thinsp;0.05, p value\u0026thinsp;=\u0026thinsp;0.215)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelationship between CONSORT adherence scores and number of eyes assessed\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFigure 4 portrays the relationship between the number of eyes assessed in each study and the corresponding CONSORT score. There is no statistically significant correlation between the number of eyes assessed and the CONSORT adherence scores (R2\u0026thinsp;=\u0026thinsp;0.01, p\u0026thinsp;=\u0026thinsp;0.638).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDifference in reporting quality between papers published in 2023 vs 2024\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere was no statistically significant difference in the adherence to the CONSORT guidelines between papers published in 2023 and those published in 2024 (mean 73.69 vs 66.2, p\u0026thinsp;=\u0026thinsp;0.137). This can be found in Supplementary Digital Content 4.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 4 - Percentage compliance to CONSORT in 2023 vs 2024]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRoB Assessment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA RoB assessment found all to have low or moderate RoB, with no consistent high-risk concerns (Supplementary Digital Content 5). This suggests that authors have taken steps to minimise bias across phacoemulsification studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 5 - RoB assessment of studies]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGRADE Assessment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA GRADE quality assessment classified most studies as being of high or moderate quality (Supplementary Digital Content 6). Two papers were marked as being of low quality. There were no consistent concerns amongst any of the domains. Since the focus of this study is reporting quality, rather than internal validity of the papers, no studies were excluded due to their RoB or GRADE assessments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 6 - GRADE assessment of studies]\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAMSTAR-2 Assessment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe evaluated previous systematic reviews using AMSTAR-2, identifying several critical flaws (Supplementary Digital Content 7). We also carried out a self-assessment AMSTAR-2, which identified no critical flaws.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e[Supplementary Digital Content 7 - AMSTAR-2 assessment of studies]\u003c/strong\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis systematic review provides the first, comprehensive assessment of adherence to the CONSORT-NPT criteria of phacoemulsification RCTs published. The review identified that overall adherence to the CONSORT-NPT checklist was slightly more than two-thirds across all included studies. This level of compliance suggests a moderate commitment to the CONSORT-NPT. It is encouraging that essential methodological elements, such as trial design, sample size determination and data analysis, were reported well. However, lower adherence to sections involving implementation fidelity and post-randomisation procedures underlies the continued need to enhance transparency, especially in the conduct and practical delivery of surgical interventions. Despite this, assessment using GRADE classified most studies as being of moderate or high quality, and the Cochrane RoB tool indicated that all studies had a low or moderate RoB. There were no concerns which were consistent across the studies, which reinforced the reliability of the trials.\u003c/p\u003e\u003cp\u003eOverall, compliance in Phacoemulsification surgery to CONSORT guidelines is similar to that in other surgical RCTs. For example, Liu et al., reported on bariatric surgery, noting that the median compliance score was 63.3%, but just 26.8% when the NPT extension items were assessed [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Similarly, Huang et al., noted a mean compliance of 59% of research papers published in otolaryngology [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. These findings suggest that whilst reporting is universally adequate, there remains significant room for improvement.\u003c/p\u003e\u003cp\u003eThere was a weak but statistically significant correlation between journal impact factor and CONSORT checklist compliance (R\u0026sup2; = 0.19, p\u0026thinsp;=\u0026thinsp;0.0269). This may suggest that publications in higher-impact journals could be associated with more rigorous reporting standards, hence reflecting the stricter editorial policies. However, the magnitude of the correlation indicates that other factors could account for variations in reporting quality, rather than impact factor alone. There was no correlation between CONSORT adherence and the number of eyes within the study (R\u0026sup2; = 0.01, p\u0026thinsp;=\u0026thinsp;0.638), or the number of authors in the study (R\u0026sup2; = 0.05, p\u0026thinsp;=\u0026thinsp;0.215). Whilst larger teams may be expected to have more comprehensive trial reporting, our findings suggest that the number of authors alone does not predict reporting quality. Similarly, there was no statistical difference in CONSORT adherence between papers published in 2023 and those published in 2024 (mean 73.69 vs 66.2, p\u0026thinsp;=\u0026thinsp;0.137).\u003c/p\u003e\u003cp\u003eImportantly, there were no studies which adequately reported the methods used to ensure care provider adherence or described any deviations from trial methodology after initiation. These are core aspects of interval validity that are especially critical in surgical RCTs, where interventions are often highly operator dependent [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Furthermore, despite the inherent challenges around blinding in surgical contexts, no studies discussed alternative strategies for minimising performance and detecting bias when blinding was not possible. This reinforces calls from previous studies for greater incorporation of practical strategies in order to mitigate unblinded trials [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAll but one study was carried out in a single centre, which can further complicate CONSORT adherence in phacoemulsification RCTs. Single-centre trials can lack the generalisability of multicentre studies, which is essential in externally validating research findings [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Furthermore, the smaller sample sizes result in reduced statistical power, consequently this can increase the risk of Type I and Type II errors [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. By encouraging collaboration between institutions, larger, well-powered studies can be carried out, which is essential in improving methodological rigor and adherence to CONSORT standards. Establishing multicentre collaboration could also promote greater adherence to reporting guidelines, as there will be more shared best practices and resources [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. In addition to this, studies with alternative designs, such as pragmatic and real-world trials, can overcome some of the limitations of RCT, hence enhancing generalizability and patient recruitment in surgical research [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eNotably, a large proportion of studies were carried out in India (n\u0026thinsp;=\u0026thinsp;10, 40%). This could be due to the prevalence of cataracts in India, and hence the large surgical volume [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. However, it is important to note that this geographic skew in the data raises concerns regarding its generalisability: healthcare infrastructures and patient populations will be markedly different across regions.\u003c/p\u003e\u003cp\u003e\u003cb\u003eAreas for improvement\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe findings from our review suggest that there are specific CONSORT-NPT checklist items which remain under-reported, and so require greater attention from authors, reviewers and editors. In particular, there is a lack of information on: care providers adhering to protocols; modifications to methods after trial commencement; why trials were ended/stopped; and strategies used when blinding is not possible. This seems to be keeping in line with the general literature, which indicates that many trials fail to report critical methodological details, which can significantly impact the validity of their results [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Whilst most papers mentioned the potential harms or unintended side effects of interventions (n\u0026thinsp;=\u0026thinsp;18 studies, 72.%), there is still room for improvement. This is a particularly important area to report on, since complications in phacoemulsification surgery can have a significant impact on outcomes and overall patient satisfaction. The CONSORT extension for Harms Checklist is a valuable framework, which can be used to provide more consistent and transparent reporting of complications or adverse events. It is essential that studies adhere to this extension, given the inherent risks of phacoemulsification, such as endophthalmitis [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThese areas represent key missed opportunities to enhance the transparency and the reproducibility of RCT studies. These components are especially vital in studies where operator skill, procedural fidelity and intra-operative variability can significantly impact the outcomes of studies. Furthermore, few studies reported whether, and how, adherence-enhancing strategies (e.g. monitoring visits, training sessions etc.) were implemented, which suggests a potential disconnect between trial protocols and real-world clinical execution. Improving reporting in this domain would allow clinicians to better interpret the feasibility, and translatability of interventions into everyday practice.\u003c/p\u003e\u003cp\u003e\u003cb\u003eImplications for Research and Clinical Practice\u003c/b\u003e\u003c/p\u003e\u003cp\u003eHigh-quality RCTs are essential to the development of evidence-based ophthalmology. However, if research is reported incorrectly, it is difficult for clinicians to evaluate the validity of findings, or to apply the interventions confidently to their clinical practice. Our findings suggest that, whilst phacoemulsification-based surgical trials are making progress towards comprehensive reporting, there is a clear need for improvement in areas of contextual and procedural transparency. To support this, we recommend that authors use the CONSORT-NPT checklists throughout the entire trial period: to guide study design; conduct phases; and during manuscript preparation. Institutions and ethical committees should make an active effort to embed reporting standards into their monitoring frameworks and protocol templates. Journals should also enforce stricter checklist-based submission requirements and offer structured training for peer-reviewers to identify any reporting omissions.\u003c/p\u003e\u003cp\u003e\u003cb\u003eLimitations\u003c/b\u003e\u003c/p\u003e\u003cp\u003eWhilst this review has several merits, it is essential to discuss potential limitations. Firstly, although we have implemented a robust systematic search strategy, it is possible that relevant studies were missed, particularly those published in non-indexed or regional journals. Secondly, the study focuses on phacoemulsification procedures, which may limit the generalisability of our findings to other Ophthalmic surgeries. Thirdly, whilst our scoring system enables a granular assessment of each CONSORT-NPT item, the subjective nature of some components may introduce reviewer bias, despite our dual review and consensus resolution method. We have attempted to minimise this by having a training session to teach all reviewers how to accurately score studies, and to address any questions. Furthermore, we have only searched studies published between 2023 and 2024, hence compliance and trends outside of those years remain unreported.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis systematic review highlights that, whilst there has been substantial adherence to certain aspects of CONSORT reporting in recent phacoemulsification studies, there are significant gaps which remain. This is particularly in relation to procedural transparency and blinding methodology, which may influence adherence of studies. By strengthening RCT adherence to CONSORT-NPT guidelines, the scientific community will enhance the quality and clinical utility of phacoemulsification surgical research, hence ultimately support better patient outcomes.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest:\u003c/strong\u003e The authors declare that they have no financial or personal conflicts of interest relevant to this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The authors declare there were no competing interests, and they received no grants or equipment\u0026rsquo;s for this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eESCRS:Cataract surgery [Internet]. Escrs.org. 2025 [cited 2025 Jul 19]. Available from: https://escrs.org/patient-portal/cataract-surgery\u003c/li\u003e\n\u003cli\u003eIntroduction: Cataract Surgery Complications. Introduction: Cataract Surgery Complications [Internet]. CRSToday. 2025 [cited 2025 Jul 19]. Available from: https://crstoday.com/articles/april-2021/introduction-cataract-surgery-complications\u003c/li\u003e\n\u003cli\u003eDong R, Ying G. Characteristics of design and analysis of ophthalmic randomized controlled trials. Ophthalmol Sci. 2023;3(2):100266. doi:10.1016/j.xops.2022.100266.\u003c/li\u003e\n\u003cli\u003eChan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365(9465):1159\u0026ndash;62. doi:10.1016/S0140-6736(05)71879-1\u003c/li\u003e\n\u003cli\u003eHopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371(9609):281\u0026ndash;3. doi:10.1016/S0140-6736(07)61835-2.\u003c/li\u003e\n\u003cli\u003eGlasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383(9913):267\u0026ndash;76. doi:10.1016/S0140-6736(13)62228-X\u003c/li\u003e\n\u003cli\u003eSchulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi:10.1136/bmj.c332\u003c/li\u003e\n\u003cli\u003eMcCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105\u0026ndash;12. doi:10.1016/S0140-6736(09)61116-8.\u003c/li\u003e\n\u003cli\u003eErgina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, et al. Challenges in evaluating surgical innovation. Lancet. 2009;374(9695):1097\u0026ndash;104. doi:10.1016/S0140-6736(09)61086-2\u003c/li\u003e\n\u003cli\u003eBoutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010;303(20):2058\u0026ndash;64. doi:10.1001/jama.2010.651\u003c/li\u003e\n\u003cli\u003eErgina PL, Barkun JS, McCulloch P, Cook JA, Altman DG; IDEAL Group. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ. 2013;346:f3011. doi:10.1136/bmj.f3011\u003c/li\u003e\n\u003cli\u003eBoutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167(1):40\u0026ndash;7. doi:10.7326/M17-0046\u003c/li\u003e\n\u003cli\u003ePattathil N, Zhao JZL, Sam-Oyerinde O, Felfeli T. Adherence of randomised controlled trials using artificial intelligence in ophthalmology to CONSORT-AI guidelines: a systematic review and critical appraisal. BMJ Health Care Inform. 2023;30(1):e100757. doi:10.1136/bmjhci-2023-100757\u003c/li\u003e\n\u003cli\u003eShea BJ, Reeves BC, Wells G, Thuku M, Hamel C, Moran J, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ. 2017;358:j4008. doi:10.1136/bmj.j4008\u003c/li\u003e\n\u003cli\u003ePage MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71\u003c/li\u003e\n\u003cli\u003eMcGowan J, Sampson M, Salzwedel DM, Cogo E, Foerster V, Lefebvre C. PRESS Peer Review of Electronic Search Strategies: 2015 Guideline Statement. Journal of Clinical Epidemiology. 2016;75:40-46. doi:10.1016/j.jclinepi.2016.01.021\u003c/li\u003e\n\u003cli\u003eHiggins JPT, Altman DG, G\u0026oslash;tzsche PC, J\u0026uuml;ni P, Moher D, Oxman AD, et al. The Cochrane Collaboration\u0026rsquo;s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928. doi:10.1136/bmj.d5928.\u003c/li\u003e\n\u003cli\u003eBrożek JL, Akl EA, Alonso-Coello P, Lang D, Jaeschke R, Williams JW, et al. Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. Allergy. 2009;64(5):669-677. doi:10.1111/j.1398-9995.2009.01973.x\u003c/li\u003e\n\u003cli\u003eLiu M, Chen J, Wu Q, Zhu W, Zhou X. Adherence to the CONSORT statement and extension for nonpharmacological treatments in randomized controlled trials of bariatric surgery: a systematic survey. Obes Rev. 2021;22:e13252. doi:10.1111/obr.13252.\u003c/li\u003e\n\u003cli\u003eHuang YQ, Traore K, Ibrahim B, Sewitch MJ, Nguyen LHP. Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement. J Otolaryngol Head Neck Surg. 2018;47(1):34. doi:10.1186/s40463-018-0277-8.\u003c/li\u003e\n\u003cli\u003eBlencowe NS, Brown JM, Cook JA, Metcalfe C, Morton DG, Nicholl J, et al. Interventions in randomised controlled trials in surgery: issues to consider during trial design. Trials. 2015;16:392. doi:10.1186/s13063-015-0918-4.\u003c/li\u003e\n\u003cli\u003eHrobjartsson A, Emanuelsson F, Thomsen ASS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials: a systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol. 2014;43(4):1272\u0026ndash;1283. doi:10.1093/ije/dyu115.\u003c/li\u003e\n\u003cli\u003eMonaghan TF, Agudelo CW, Rahman SN, Wein AJ, Lazar JM, Everaert K, et al. Blinding in clinical trials: seeing the big picture. Medicina. 2021;57(7):647. doi:10.3390/medicina57070647.\u003c/li\u003e\n\u003cli\u003eHe Y, Zhang R, Shan W, Chen H, Li X, Wang L, et al. Evaluating the completeness of the reporting of abstracts since the publication of the CONSORT extension for abstracts: an evaluation of randomized controlled trials in ten nursing journals. Trials. 2023;24(1):423. doi:10.1186/s13063-023-07419-5.\u003c/li\u003e\n\u003cli\u003eShreffler J, Huecker MR. Type I and type II errors and statistical power. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Mar 13. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557530/\u003c/li\u003e\n\u003cli\u003eKane RL, Wang J, Garrard J. Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol. 2007;60(3):241\u0026ndash;249. doi:10.1016/j.jclinepi.2006.06.016.\u003c/li\u003e\n\u003cli\u003eKhajuria A. Surgical research: from comic opera to epic symphony. Lancet. 2024;403(10438):1745\u0026ndash;1746. doi:10.1016/S0140-6736(23)02052-4.\u003c/li\u003e\n\u003cli\u003eMurthy G, Gupta SK, John N, Vashist P. Current status of cataract blindness and Vision 2020: the right to sight initiative in India. Indian J Ophthalmol. 2008;56(6):489\u0026ndash;494. doi:10.4103/0301-4738.42774.\u003c/li\u003e\n\u003cli\u003eHemmerich C, Corcoran A, Johnson AL, Wilson A, Orris O, Arellanes R, et al., Reporting of complications in rhinoplasty randomized controlled trials: an analysis using the CONSORT extension for harms checklist. Otolaryngol Head Neck Surg. 2024;171(1):81\u0026ndash;89. doi:10.1002/ohn.765.\u003c/li\u003e\n\u003cli\u003eShi S-L, Yu X-N, Cui Y-L, Zheng S-F, Shentu X-C. Incidence of endophthalmitis after phacoemulsification cataract surgery: a meta-analysis. Int J Ophthalmol. 2022;15(2):327\u0026ndash;335. doi:10.18240/ijo.2022.02.20.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Phacoemulsification, CONSORT, RCTs, Compliance, Non-pharmaceutical Trials, Surgery","lastPublishedDoi":"10.21203/rs.3.rs-7190088/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7190088/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e\u003cp\u003ePhacoemulsification surgery constitutes a large proportion of Ophthalmic procedures and continues to evolve rapidly. However, poor reporting in randomised controlled trials (RCTs) can impede interpretation and application of findings. The Consolidated Standards of Reporting Trials - Non-pharmacological Treatments (CONSORT-NPT) guidelines aim to improve transparency, but adherence in phacoemulsification RCTs remains unclear.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e\u003cp\u003eA systematic review was conducted according to PRISMA and AMSTAR-2 standards. Five databases were searched for phacoemulsification RCTs published between January 2023 and December 2024. Studies were assessed using the 25-item CONSORT-NPT checklist. Data on study characteristics (number of authors, journal impact factor, number of eyes, study designs) were extracted. Relationships between CONSORT scores and study characteristics were analysed using Spearman\u0026rsquo;s rank correlation and unpaired t-tests. Study quality was assessed using the Cochrane Risk of Bias tool and GRADE framework.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e\u003cp\u003eTwenty-five RCTs met the inclusion criteria. The mean CONSORT compliance score was 68.6% (range: 40.0\u0026ndash;83.8%). Complete adherence was seen in reporting trial design, eligibility, and statistical methods, but none adequately reported implementation fidelity or protocol deviations for bias mitigation when blinding was not possible. A weak but statistically significant positive correlation existed between journal impact factor and CONSORT compliance (R\u0026sup2; = 0.190, p\u0026thinsp;=\u0026thinsp;0.0269). No significant difference was found between studies published in 2023 and 2024 (p\u0026thinsp;=\u0026thinsp;0.137). Risk of bias was low or moderate; methodological quality was rated moderate or high via GRADE.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e\u003cp\u003eReporting quality is moderate, with critical gaps in methodological transparency. Emphasising full adherence to CONSORT-NPT is essential to improve the quality, reproducibility, and clinical relevance of phacoemulsification research.\u003c/p\u003e","manuscriptTitle":"CONSORT Compliance of Phacoemulsification Randomised Controlled Trials: A Systematic Review","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-03 23:59:40","doi":"10.21203/rs.3.rs-7190088/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a6e2e419-d489-46ba-a147-f83a11941ab0","owner":[],"postedDate":"September 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":53765785,"name":"Biological sciences/Neuroscience/Visual system"},{"id":53765786,"name":"Health sciences/Medical research/Outcomes research"}],"tags":[],"updatedAt":"2025-10-08T12:09:24+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-03 23:59:40","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7190088","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7190088","identity":"rs-7190088","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}