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| 1 | FDA MAUDE database analysis of titanium middle ear prosthesis显示文摘Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain function.Despite favorable auditory outcomes,these interventions have associated risks and complications.This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications,interventions,and root cause analysis(RCA)findings.Materials and methods:The MAUDE database was searched for Medical Device Reports(MDRs)relating to PORPs and TORPs from 2010 to 2020.MDR event descriptions were reviewed,and adverse events were identified as a device issue,patient issue,and/or packaging issue that occurred intraoperatively or postoperatively.Results:Our search identified 70 MDRs which included 110 reported adverse events.Events consisted of 63 device issues,often due to device breaks and displacements,39 patient issues,including common complaints of hearing loss and erosion,and 8 packaging issues.When comparing PORPs and TORPs,TORPs had more reported device issues whereas PORPs had more packaging issues.Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery.For devices returned to the manufacturer,RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.Conclusion:Device issues were the most common adverse events and frequently required subsequent intervention.Displacement occurred more often with TORPs and was associated with changes in hearing or erosion.The findings of this study are purely descriptive and may not have direct clinical relevance. | Jaclyn Carey Sairisheel Gabbireddy Luke Mammen Gianna Rosamilia Varun Patel David Foyt Steven Parnes | 2022 | Journal of Otology2022，17，1： | 1 |
| 2 | Long-term outcomes in patients initially responsive to selective laser trabeculoplasty显示文摘AIM: To determine the long-term effects of selective laser trabeculoplasty(SLT) on intraocular pressure(IOP)and the number of medications used up to 5y following treatment in glaucoma patients receiving maximally tolerated medical therapy(MTMT).·METHODS: The Wills Eye Hospital Glaucoma Research Center retrospectively reviewed the charts of glaucoma patients who underwent SLT after receiving MTMT. Eyes that did not achieve their target pressure within 3mo following SLT were excluded from the study. Changes in mean IOP and number of glaucoma medications used were analyzed at 1, 3, and 5y following SLT.·RESULTS: Seventy-five eyes of 67 patients were included in the study. Fifteen eyes that received SLT failed to achieve their target pressure within 3mo and were excluded from the study. The average follow-up time was 37.4mo(±14.4). Mean IOP was significantly reduced 1y after treatment(P =0.005). It was also reduced3, 5y after treatment without reaching statistical significance(P =0.20 and P =0.072, respectively). There was a significant decrease in mean number of medications used 1, 3, 5y after treatment(P <0.001, P <0.001, and P =0.039, respectively). In the span of 5y, 2eyes(2.7%) underwent repeat SLT, 7 eyes(9.3%) underwent glaucoma surgery and an additional 3 eyes( 4. 0 %)underwent both.·CONCLUSION: SLT significantly reduced the number of glaucoma medications used 5y following treatment in glaucoma patients receiving MTMT. SLT may delay operating-room surgery. | Varun Patel Eman El Hawy Michael Waisbourd Camila Zangalli Daniel M.Shapiro Lalita Gupta Michael Hsieh Abigail Kasprenski L.Jay Katz George L.Spaeth | 2015 | International Journal of Ophthalmology(English edition)2015，8，5： | 0 |
| 3 | Changes in macular thickness following glaucoma surgery显示文摘Dear Sir,Previous reports have illustrated reversible structural changes in optic disc cupping,the lamina cribrosa,and the retinal nerve fiber layer(RNFL)following glaucoma surgery[1-3].However,few studies have assessed changes in macular thickness following such intervention.Our aim was to investigate the impact of intraocular pressure(IOP)reduction after glaucoma surgery on total macular | Priyamvada M. Pitale Usma Chatha Varun Patel Lalita Gupta Michael Waisbourd Michael J Pro | 2016 | International Journal of Ophthalmology(English edition)2016，9，8： | 0 |
| 4 | Clinical trials in otology:Examining trends and framework for prioritization显示文摘Objective:To characterize otologic clinical trials and examine otologic clinical trial trends from 2008 to 2018 using the clinicaltrials.gov database.Methods:Data was collected from clinicaltrials.gov and included all clinical trials that focused on otology from 2008 to 2018.Outcome measures include status of trials,funding sources,details regarding otologic conditions studied,and trends in clinical trials.Results:There were 992 otology clinical trials from 2008 to 2018.457(46.1%)were completed and 94(9.5%)were discontinued.Industry remained the highest(76.5%)contributor to otology clinical trials.The otologic conditions studied,from most common to least common,include hearing loss(40.6%),vestibulopathy(18.8%),tinnitus(18.8%),and otitis media(15.1%).The number of otology clinical trials increased by an average of 12.0 trials per year from 2008 to 2018(p<0.001).The number of otology clinical trials focusing on hearing loss and vestibulopathy significantly increased over the studied period(p<0.001),while those focusing on tinnitus and otitis media did not(p=0.09 and p=0.20,respectively).The majority of clinical trials on each of these four conditions focused on treatment options.Conclusion:Our study describes trends in otology clinical trials registered on clinicaltrials.gov from 2008 through 2018.The total number of clinical trials over this time period increased significantly,driven by trials investigating hearing loss and vestibulopathy.Furthermore,most clinical trials were industrysponsored and focused on treatment modalities.Our study provides an outline of otology clinical trials registered in a US web-based database,which may be of use for the development of future clinical trials. | Jake Altshuler Rohan Viswanathan Divya B.Dasani Katherine Webb Tam Ramsey Varun Patel Randall Ruffner Jason Mouzakes David Foyt | 2021 | Journal of Otology2021，16，2： | 0 |
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