Shing Chuen Chow, Jeffrey Man Yeung Lo, Mehnaz Quddus, Qing Li, Wai Ching Lam, Nicholas Siu Kay Fung
{"title":"一项前瞻性随机对照研究：25G 2万刀/分钟和1万刀/分钟玻璃体切割的性能、安全性和效率比较","authors":"Shing Chuen Chow, Jeffrey Man Yeung Lo, Mehnaz Quddus, Qing Li, Wai Ching Lam, Nicholas Siu Kay Fung","doi":"10.1186/s40942-024-00613-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The aim of this study was to compare the safety and efficacy of 20,000 cuts per minute (cpm) with 10,000 cpm in vitreous cutters.</p><p><strong>Methods: </strong>This was a prospective, parallel, single masked randomized control trial comparing the 25 gauge 20,000 cpm HYPERVIT Dual Blade from Alcon Laboratories, Fort Worth, TX, USA and 10,000 cpm ULTRAVIT vitrectomy cutter from Alcon Laboratories, Inc, Fort Worth, TX. Standard T-test by SPSS version 27 was used to compare efficiency and safety between two groups.</p><p><strong>Results: </strong>In total 72 patients were recruited for the study and among them 71 patients completed the study. This study did not show any significant difference between 20,000 cpm probe and 10,000 cpm probe (p value = 0.347) for the core vitrectomy duration in all included eyes. The mean of core vitrectomy time was 269.28 s in the 25 gauge 20,000 cpm group and 289.44 s in the 25 gauge 10,000 cpm group. However, by comparing the two systems operated on epiretinal membrane eyes, 20,000 cpm probe had a significantly shorter mean core vitrectomy time than 10,000 cpm group (P = 0.03). The majority of all the patients had no intraoperative retinal tear (98.6.8%) and post-operative retinal tear (95.8%). There were no intraoperative iatrogenic breaks, and 3 postoperative retinal tears with rhegmatogenous retinal detachment (RRD) were documented. All the retinal tears belongs to the 20,000 cpm group but no significant difference was found between the two groups in terms of retinal tear and complications.</p><p><strong>Conclusions: </strong>25-gauge 20,000 cpm Hypervit dual blade showed a faster trend in vitrectomy time although this was not statistically significant in all included eyes. By comparing vitrectomy time operated on epiretinal membrane eyes, a significant shorter time was found in 25-gauge 20,000 cpm. With more efficient and faster vitrectomy systems, the effect of surgeon factor likely plays a larger role. Our study suggest that the two devices may have a similar efficacy and safety. However, further studies may be needed to compare the core vitrectomy time between them after excluding the surgeon factor influence.</p>","PeriodicalId":14289,"journal":{"name":"International Journal of Retina and Vitreous","volume":"11 1","pages":"45"},"PeriodicalIF":2.4000,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11998420/pdf/","citationCount":"0","resultStr":"{\"title\":\"Performance, safety and efficiency comparison between a 25G 20,000 and a 10,000 cuts per minute vitrectomy: a prospective randomized control study.\",\"authors\":\"Shing Chuen Chow, Jeffrey Man Yeung Lo, Mehnaz Quddus, Qing Li, Wai Ching Lam, Nicholas Siu Kay Fung\",\"doi\":\"10.1186/s40942-024-00613-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The aim of this study was to compare the safety and efficacy of 20,000 cuts per minute (cpm) with 10,000 cpm in vitreous cutters.</p><p><strong>Methods: </strong>This was a prospective, parallel, single masked randomized control trial comparing the 25 gauge 20,000 cpm HYPERVIT Dual Blade from Alcon Laboratories, Fort Worth, TX, USA and 10,000 cpm ULTRAVIT vitrectomy cutter from Alcon Laboratories, Inc, Fort Worth, TX. Standard T-test by SPSS version 27 was used to compare efficiency and safety between two groups.</p><p><strong>Results: </strong>In total 72 patients were recruited for the study and among them 71 patients completed the study. This study did not show any significant difference between 20,000 cpm probe and 10,000 cpm probe (p value = 0.347) for the core vitrectomy duration in all included eyes. The mean of core vitrectomy time was 269.28 s in the 25 gauge 20,000 cpm group and 289.44 s in the 25 gauge 10,000 cpm group. However, by comparing the two systems operated on epiretinal membrane eyes, 20,000 cpm probe had a significantly shorter mean core vitrectomy time than 10,000 cpm group (P = 0.03). The majority of all the patients had no intraoperative retinal tear (98.6.8%) and post-operative retinal tear (95.8%). There were no intraoperative iatrogenic breaks, and 3 postoperative retinal tears with rhegmatogenous retinal detachment (RRD) were documented. All the retinal tears belongs to the 20,000 cpm group but no significant difference was found between the two groups in terms of retinal tear and complications.</p><p><strong>Conclusions: </strong>25-gauge 20,000 cpm Hypervit dual blade showed a faster trend in vitrectomy time although this was not statistically significant in all included eyes. By comparing vitrectomy time operated on epiretinal membrane eyes, a significant shorter time was found in 25-gauge 20,000 cpm. With more efficient and faster vitrectomy systems, the effect of surgeon factor likely plays a larger role. Our study suggest that the two devices may have a similar efficacy and safety. However, further studies may be needed to compare the core vitrectomy time between them after excluding the surgeon factor influence.</p>\",\"PeriodicalId\":14289,\"journal\":{\"name\":\"International Journal of Retina and Vitreous\",\"volume\":\"11 1\",\"pages\":\"45\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-04-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11998420/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Retina and Vitreous\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s40942-024-00613-w\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Retina and Vitreous","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40942-024-00613-w","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Performance, safety and efficiency comparison between a 25G 20,000 and a 10,000 cuts per minute vitrectomy: a prospective randomized control study.
Background: The aim of this study was to compare the safety and efficacy of 20,000 cuts per minute (cpm) with 10,000 cpm in vitreous cutters.
Methods: This was a prospective, parallel, single masked randomized control trial comparing the 25 gauge 20,000 cpm HYPERVIT Dual Blade from Alcon Laboratories, Fort Worth, TX, USA and 10,000 cpm ULTRAVIT vitrectomy cutter from Alcon Laboratories, Inc, Fort Worth, TX. Standard T-test by SPSS version 27 was used to compare efficiency and safety between two groups.
Results: In total 72 patients were recruited for the study and among them 71 patients completed the study. This study did not show any significant difference between 20,000 cpm probe and 10,000 cpm probe (p value = 0.347) for the core vitrectomy duration in all included eyes. The mean of core vitrectomy time was 269.28 s in the 25 gauge 20,000 cpm group and 289.44 s in the 25 gauge 10,000 cpm group. However, by comparing the two systems operated on epiretinal membrane eyes, 20,000 cpm probe had a significantly shorter mean core vitrectomy time than 10,000 cpm group (P = 0.03). The majority of all the patients had no intraoperative retinal tear (98.6.8%) and post-operative retinal tear (95.8%). There were no intraoperative iatrogenic breaks, and 3 postoperative retinal tears with rhegmatogenous retinal detachment (RRD) were documented. All the retinal tears belongs to the 20,000 cpm group but no significant difference was found between the two groups in terms of retinal tear and complications.
Conclusions: 25-gauge 20,000 cpm Hypervit dual blade showed a faster trend in vitrectomy time although this was not statistically significant in all included eyes. By comparing vitrectomy time operated on epiretinal membrane eyes, a significant shorter time was found in 25-gauge 20,000 cpm. With more efficient and faster vitrectomy systems, the effect of surgeon factor likely plays a larger role. Our study suggest that the two devices may have a similar efficacy and safety. However, further studies may be needed to compare the core vitrectomy time between them after excluding the surgeon factor influence.
期刊介绍：
International Journal of Retina and Vitreous focuses on the ophthalmic subspecialty of vitreoretinal disorders. The journal presents original articles on new approaches to diagnosis, outcomes of clinical trials, innovations in pharmacological therapy and surgical techniques, as well as basic science advances that impact clinical practice. Topical areas include, but are not limited to: -Imaging of the retina, choroid and vitreous -Innovations in optical coherence tomography (OCT) -Small-gauge vitrectomy, retinal detachment, chromovitrectomy -Electroretinography (ERG), microperimetry, other functional tests -Intraocular tumors -Retinal pharmacotherapy & drug delivery -Diabetic retinopathy & other vascular diseases -Age-related macular degeneration (AMD) & other macular entities
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