EyeSouth Partners’ Post

After I was involved in setting up surgical clinical trial with placebo I decided to learn more on the topic and see what are the latest guidelines on such clinical trials. I admit initially having ethical concerns about the use of placebo in surgical clinical trials but my research made me change my mind. While placebo is not an option for oncology there are many other areas where it is important part of the safety evaluation. #clinicaltrials #surgery #clinicalevaluation

Ophthopedia Update:Reply: We thank Dr Liu et al for their interest in our Ophthalmic Technology Assessment (OTA) article evaluating corneal hysteresis (CH) for the diagnosis of glaucoma and assessment of progression risk,1 and their comments concerning the relationship between CH and central corneal thickness (CCT). Although this factor was not part of the question for assessment in our OTA, we agree that CCT may be an important contributor to CH. #Ophthalmology #ophthotwitter #eyecare

Exciting news in medical innovation! Signum Surgical has received FDA De Novo clearance for BioHealx, a groundbreaking treatment for anal fistulas. This bioabsorbable implant offers a minimally invasive approach to a painful condition affecting thousands annually. Moshe Zilversmit, Co-Founder and CEO of Signum Surgical, expressed pride in this achievement, emphasizing its potential to enhance patient care. The clearance follows a successful clinical trial involving 32 patients with recurrent anal fistulas. Dr. Peter Ónody, Principal Investigator, highlighted BioHealx's potential to reduce multiple surgeries and lower healthcare costs. This FDA approval marks a significant step towards addressing an unmet clinical need in colorectal care. Signum Surgical is now exploring partnerships to bring BioHealx to market swiftly, offering new hope for patients struggling with this challenging condition. https://lnkd.in/e-pJCxjb 📰 Stay ahead of the curve by following Practical Patient Care on LinkedIn for more industry news and insights. You can also access our latest edition here: https://lnkd.in/guUBWkRE #PracticalPatientCare #MedicalInnovation #FDAApproval #ColorectalCare

After a break in August we are back with the next episode in our podcast which is about using placebo in surgical clinical trials and the international guidelines for setting up such studies. https://lnkd.in/eEkZp6GV #clinicaltrials #surgery #placebo

Arshad M. Khanani, MD, MA, FASRS, discusses the positive 2-year results of the #GATHER2 trial investigating #avacincaptadpegol for #geographicatrophy here at the American Academy of Ophthalmology meeting. 👁️🗨️ “When we look at the absolute reduction in GA growth lesion, we see more than doubling of the treatment effect in patients treated with avacincaptad pegol, whether every month or every other month, over 2 years compared to the effect we saw at 1 year,” he said. Find out more ⬇: #OcularSurgeryNews #AAO2023 #Retina https://lnkd.in/e8dfpkNe

Ophthopedia Update:Reply: Lum and Goel present their reservations regarding our analysis of ophthalmology workforce adequacy from the Health Resources and Services Administration (HRSA) workforce microsimulation model. We appreciate their critical appraisal of the model’s assumptions and the opportunity to discuss our analysis further. #Ophthalmology #ophthotwitter #eyecare

🤝Endospan Ltd. entered a funding agreement with Artivion, Inc. for up to $25m of additional loans, which will be used for the pursuit of an FDA approval for the Nexus Stent Graft System. 💉The endovascular, off-the-shelf system is designed to treat aortic arch disease, including both aortic aneurysms and aortic dissection. 📢 Endospan CEO Kevin Mayberry shared: “We share a commitment with Artivion to delivering minimally invasive solutions to help surgeons address the complex challenges of this growing market.” 🔗 Learn more: https://lnkd.in/dR_TW_sT 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dm9DRJtQ #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #HealthTech #Surgeons #GuidedSolutions

Ophthopedia Update:Impact of Peripheral Anterior Synechiae on the Outcome of Combined Phacoemulsification, Goniosynechialysis, and Goniotomy for Primary Angle Closure Glaucoma and Cataract: A Multicenter Observational Study: Précis: The combination of phacoemulsification, goniosynechialysis and goniotomy is an effective treatment for primary angle closure glaucoma patients with cataract, and this is not linked to the extent of preoperative peripheral anterior synechiae. Purpose: To evaluate the impact of the extent of peripheral anterior synechiae (PAS) on the effectiveness and safety of combined phacoemulsification (PEI), goniosynechialysis (GSL), and goniotomy (GT) in eyes with primary angle closure glaucoma (PACG) and cataract. Patients and Methods: This study included patients diagnosed with PACG and cataracts who underwent combined PEI and 120 degrees GSL plus GT (PEI+GSL+GT) between April 2020 and October 2022 at 10 ophthalmic institutes. Eligible patients were divided into 3 groups based on the extent of PAS: 180°≤PAS #Ophthalmology #Eye #Ophthotwitter

Saumya M. Shah, MD (USC Roski Eye Institute), Daniel Su, MD, David Boyer, MD, of Retina-Vitreous Associates Medical Group review what is known, and promised, about #Photobiomodulation, following the completion of 2 major trials. In exudative #AgeRelatedMacularDegeneration (#WetAMD), significant strides — such as the development of anti-vascular endothelial growth factor (#AntiVEGF) therapies — have pushed the treatment possibilities forward and rewritten the likely course of the disease for many patients. However, for most patients, #AMD is nonexudative (dry), and treatments for those patients remain largely limited.1,2 Recent developments in the form of #ComplementInhibitorTreatments (such as pegcetacoplan and avacincaptad pegol) are showing promise in slowing progression rates of #GeographicAtrophy (GA) — an advanced, vision-threatening form of #DryAMD affecting nearly 1 in 5 patients. But for the dry AMD patients without GA, a tremendous gap in therapeutic avenues persists. Read here: https://brnw.ch/21wI43f #Ophthalmology #Ophthalmologist #EyeHealth #EyeCare #DryAMD #InflammatoryMarkers #VisualAcuity #BestCorrectedVisualAcuity #BCVA #LIGHTSITE #ClinicalTrial #EyeResearch #MedicalResearch

🔬 The Israel-based company said the milestone was supported by clinical evidence from its ongoing European clinical study, marking a significant advancement for its spinal fusion technology. 📣 "The system has garnered significant interest in the US market and this clearance paves the way for us to introduce our transformative solution to the US market, fostering collaboration with leading surgeons and enhancing patient care,” ZygoFix Ltd. CEO Ofer Levy said. 🔗 Read more: https://lnkd.in/dgembrXJ 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dQARD_Wi #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions