{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T06:31:03Z","timestamp":1772605863514,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.16098.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2023,1,25]],"date-time":"2023-01-25T00:00:00Z","timestamp":1674604800000}}],"reference-count":41,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2023,1,25]],"date-time":"2023-01-25T00:00:00Z","timestamp":1674604800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009053","name":"The Wellcome Trust DBT India Alliance","doi-asserted-by":"publisher","award":["IA\/CPHE\/17\/1\/503337"],"award-info":[{"award-number":["IA\/CPHE\/17\/1\/503337"]}],"id":[{"id":"10.13039\/501100009053","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>\n                    <ns3:bold>Introduction<\/ns3:bold>\n                    <ns3:bold>:<\/ns3:bold>\n                    Globally, at least 30 million cataract surgeries are required annually to prevent cataract-related blindness. Corneal endothelial decompensation is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The increasing ageing population and reduced visual impairment threshold for cataract surgery have resulted in rising cataract surgical rates and hence, an increase in corneal endothelial decompensation is expected. The role of phaco tip position on corneal endothelial damage is ambiguous. Previous studies have reported contradictory results and were also underpowered to detect a significant difference due to small sample sizes. With no consensus regarding the most cornea-friendly phaco tip position (bevel-up versus bevel-down) during phacoemulsification, we propose a randomised clinical trial with a robust design using direct chop phaco-technique.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Objective:<\/ns3:bold>\n                    To compare the effect of phaco tip position (bevel-up vs. bevel-down) on corneal endothelial cell count during phacoemulsification.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Methods:<\/ns3:bold>\n                    A randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio is proposed. By adopting stratified randomisation (according to cataract grade), we will randomly allocate 480 patients aged &gt;18 years with immature cataract into bevel-up and bevel-down groups at two centres. History of significant ocular trauma, previous intraocular surgery, shallow anterior chamber, low endothelial cell count, pseudoexfoliation syndrome, intraocular inflammation, and corneal endothelial dystrophy are the key exclusion criteria. The primary outcome is postoperative endothelial cell count at one month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30, and intraoperative complications.\n                  <\/ns3:p>\n                  <ns3:p>\n                    <ns3:bold>Trial registration:<\/ns3:bold>\n                    Clinical Trial Registry of India\n                    <ns3:ext-link xmlns:ns4=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" ns4:href=\"http:\/\/ctri.nic.in\/Clinicaltrials\/pmaindet2.php?trialid=29764&amp;EncHid=&amp;userName=2019\/02\/017464\">CTRI\/2019\/02\/017464<\/ns3:ext-link>\n                    (05\/02\/2019).\n                  <\/ns3:p>","DOI":"10.12688\/wellcomeopenres.16098.2","type":"journal-article","created":{"date-parts":[[2023,1,25]],"date-time":"2023-01-25T07:40:26Z","timestamp":1674632426000},"page":"167","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Does the phaco TIp position during clear corneal Phacoemulsification Surgery adversely affect corneal endothelium? TIPS study protocol for a randomised, triple-masked, parallel-group trial of bevel-up versus bevel-down phacoemulsification"],"prefix":"10.12688","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5908-5921","authenticated-orcid":false,"given":"Soujanya","family":"Kaup","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1454-7114","authenticated-orcid":false,"given":"Siddharudha","family":"Shivalli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chinnappa","family":"Ajjinicanda Ganapathi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cynthia","family":"Arunachalam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1005-7011","authenticated-orcid":false,"given":"John","family":"Buchan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suresh","family":"Kumar Pandey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krishna","family":"Prasad Kudlu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2023,1,25]]},"reference":[{"key":"ref-1","article-title":"World Health Organisation Fact Sheets.","year":"2019"},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"635-7","DOI":"10.1136\/bjo.85.6.635","article-title":"Cataract and \u201cVision 2020-the right to sight\u201d initiative.","volume":"85","author":"A Foster","year":"2001","journal-title":"Br J Ophthalmol."},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"e888-97","DOI":"10.1016\/S2214-109X(17)30293-0","article-title":"Magnitude, temporal trends, and projections of the global prevalence of blindness and distance and near vision impairment: a systematic review and meta-analysis.","volume":"5","author":"R Bourne","year":"2017","journal-title":"Lancet Glob Health."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"2-4","DOI":"10.1016\/j.ophtha.2013.10.002","article-title":"Rising cataract surgery rates: demand and supply.","volume":"121","author":"J Erie","year":"2014","journal-title":"Ophthalmology."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"1029-31","DOI":"10.1038\/s41433-019-0383-5","article-title":"Failing to plan and planning to fail. 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D'Annunzio Chieti-Pescara, Chieti, 01 Feb 2021, version 1, 2 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/5-167\/v1#referee-response-42165","order":0,"name":"referee-response-42165","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Soujanya Kaup<\/b>; \n<i>Posted: 26 Dec 2022<\/i>; 1. Lack of controls to determine if the bevel-up vs. bevel-down technique was followed as per allocation. \n<b>Response:<\/b> The surgeons are experienced in cataract surgeries and were familiar with both bevel-up and bevel-down phaco phacoemulsification. Immediately prior to starting the trial, the surgeons were asked to perform a minimum of 25 cases with each technique so that they adhere to the standard operating procedure for the surgical protocols in each of the trial arm. &nbsp; At the end of each surgery, research assistant asks the surgeon to self-evaluate if they had any difficulty in adhering to the surgical protocol. If the surgeon states that they had to deviate from the surgical protocol, this would be noted and reported. &nbsp; Also, a randomly selected sample of the surgical videos will be independently evaluated by a surgeon outside the trial and will be asked to assign them to bevel-up or -down groups and this will be compared to the original assignment. This is updated in the procotol.  2. What percentage (time or energy) of the phacoemulsification must be done with the tip in this position. This aspect will probably affect the sample size calculation, as would the inclusion of confounding parameters such as centre\/surgeon and grading strata. &nbsp; \n<b>Response: <\/b>The phaco-tip will be placed in the given position (based on the randomisation) throughout nucleus management (i.e., 100% of the time). Assuming the randomisation was effective in distributing cataract density between the two arms, this is not a concern \u2013 and we therefore don\u2019t think it is necessary to use phaco time or energy as the driver for sample size calculation as the unit of randomisation is the patient not the \u201csecond of phaco time\u201d or the \u201cWatts of phaco power\u201d.  3. The follow-up time would probably not be long enough to see the final endothelial cell loss or decrease in central thickness. see for example DOI: 10.1007\/s10792-016-0283-7 &nbsp; &nbsp; \n<b>Response:<\/b> It can be acknowledged that the graph of CCT post phaco may not reach total stability until a later time point (60 or 90 days in the study quoted). However, we think it is reasonable to assume that the endothelial cell counts and CCT at earlier time points are extremely strong predictors for final outcomes. We see no reason to be concerned that bevel up, or bevel down, might cause a late drop in cell count 3 months after surgery compared to the other arm of the trial. &nbsp; Also, studies have concluded that the rate of endothelial cell loss is maximum during the first month post-uneventful cataract surgery, and thereafter no accelerated cell loss takes place. Hence, we opted to choose post-op one month to evaluate endothelial count. &nbsp;  Beato JN, Esteves-Leandro J, Reis D, Falc&atilde;o M, Rosas V, Carneiro &Acirc;, et al. Corneal structure and endothelial morphological changes after uneventful phacoemulsification in type 2 diabetic and nondiabetic patients. Arq Bras Oftalmol;84(5):454\u201361. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/34586219  4. I was unable to locate the data-set, maybe my fault. &nbsp; \n<b>Response:<\/b> There are no data-sets associated with this article. The DSMC Charter, Participant information sheet and Consent forms are available at https:\/\/doi.org\/10.17605\/OSF.IO\/5YS6W  5. How will the endothelial cell loss be recorded, absolute loss or percentage decrease, for the evaluation of between technique differences? \n<b>Response: <\/b>Both ways of presenting the data are possible. Absolute number of endothelial cells lost will be measured in both the groups. Percentage of endothelial cell loss will also be calculated as = (preoperative cell count \u2212 postoperative cell count)\/(preoperative cell count &times; 100%) Updated in the protocol. &nbsp;  6. SPSS 16 is a bit outdated. Consider using R? \n<b>Response:<\/b> STATA 17 will be used. Updated in the protocol.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/5-167\/v2#referee-comment-5210","order":1,"name":"referee-comment-5210","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.20845.r54509, Anthony Vipin Das, Department of EyeSmart EMR & AEye, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, Telangana, 27 Feb 2023, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/5-167\/v2#referee-response-54509","order":2,"name":"referee-response-54509","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.20845.r69451, Sharon D'Souza, Department of Cornea and Refractive surgery, Narayana Nethralaya, Bengaluru, Karnataka, 04 Jan 2024, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/5-167\/v2#referee-response-69451","order":3,"name":"referee-response-69451","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work is supported by the DBT\/Wellcome Trust India Alliance Fellowship\/Grant [IA\/CPHE\/17\/1\/503337] awarded to Dr Soujanya Kaup. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}