Comparison of the short-term effectiveness and safety profile of ab interno combined trabeculotomy using 2 types of trabecular hooks

2020 ◽  
Vol 64 (4) ◽  
pp. 407-413 ◽  
Author(s):  
Takashi Omoto ◽  
Takashi Fujishiro ◽  
Kimiko Asano-Shimizu ◽  
Koichiro Sugimoto ◽  
Rei Sakata ◽  
...  
Keyword(s):  
Author(s):  
Matthew B. Schlenker ◽  
Jeb Alden Ong ◽  
Pearson Wu ◽  
Delan Jinapriya ◽  
Barend Zack ◽  
...  

2019 ◽  
Vol 6 (5) ◽  
pp. e591 ◽  
Author(s):  
Angelo Ghezzi ◽  
Giancarlo Comi ◽  
Luigi Maria Grimaldi ◽  
Lucia Moiola ◽  
Carlo Pozzilli ◽  
...  

ObjectiveThis phase I study investigated pharmacokinetic (PK) and pharmacodynamic (PD) profiles of natalizumab in pediatric patients with relapsing-remitting MS (RRMS).MethodsPediatric patients with RRMS who were prescribed natalizumab 300 mg IV every 4 weeks were enrolled. Blood samples were collected on days 1, 2, 8, 15, and 22 and at weeks 4, 8, 12, and 16 to estimate PK parameters; PD properties were evaluated by measuring α4-integrin saturation and lymphocyte counts over time. Natalizumab's safety profile was also evaluated.ResultsPK parameters were similar to those reported in adult patients; natalizumab concentrations peaked approximately 1 day after infusion in most of the participants (Cmax 142.9 μg/mL, AUClast 47389.4 hr*μg/mL), followed by a biphasic decline with a rapid distribution phase and a slow elimination phase, with a terminal half-life of 215.1 hours. In terms of PD, both time course and magnitude of α4-integrin saturation and increase in lymphocyte counts were similar to those observed in adults. During the 16-week study follow-up, 3 adverse events attributed to natalizumab were observed; no unexpected safety events occurred.ConclusionsPK profile, α4-integrin saturation, lymphocyte counts, and safety observed in these pediatric patients are comparable to those reported in adults.Classification of evidenceThis study provides Class I evidence that natalizumab PK/PD parameters and safety profile are similar in adults and pediatric patients in the short term. Longer studies, also including a larger number of younger subjects (aged 10–12 years), are required to further inform about long-term PK and PD parameters in pediatric patients with MS.


Heart ◽  
2015 ◽  
Vol 101 (Suppl 4) ◽  
pp. A13.2-A14
Author(s):  
Peysh Patel ◽  
Chia Yau ◽  
Simerjit Thapar ◽  
James Foley ◽  
Murad Khan ◽  
...  

2018 ◽  
Vol 6 (8) ◽  
pp. 232596711878987 ◽  
Author(s):  
Chanseok Rhee ◽  
Eyal Amar ◽  
Mark Glazebrook ◽  
Catherine Coday ◽  
Ivan H. Wong

Background: Acetabular cartilage lesions are a common abnormality found in patients undergoing hip arthroscopic surgery and may cause pain and functional limitations. Several strategies have been developed to treat chondral defects, with no overwhelming success. Recently, BST-CarGel has gained interest as a scaffolding material that can be injected into the microfracture site to stabilize the clot and facilitate cartilage repair. Purpose: To perform a retrospective analysis of prospectively collected data to evaluate the safety profile and short-term clinical and radiographic outcomes of patients treated arthroscopically with BST-CarGel for acetabular chondral defects in conjunction with microfracture. Study Design: Case series; Level of evidence, 4. Methods: A retrospective chart review was performed on all patients who underwent hip arthroscopic surgery by the senior surgeon to identify those who had BST-CarGel applied to their hip from November 2014 to July 2016, and basic demographic information for those patients was obtained. Operative reports and patient charts were reviewed to assess intraoperative and postoperative complications as well as to obtain the details of surgery, including lesion size and treatment method of the labrum (repair vs reconstruction). All patients filled out self-reported questionnaires, including the international Hip Outcome Tool (iHOT), Hip Outcome Score–Activities of Daily Living (HOS-ADL), and Hip Outcome Score–Sports Profile (HOS-SP) at the time of consultation and at 1 year postoperatively, and results were used to assess the clinical outcomes of surgery. Results: Thirty-seven patients (37 hips) with a mean age of 36.19 years at the time of the index procedure were evaluated. There were 30 male patients, and 20 procedures were performed on the right hip. The minimum follow-up was 1 year, with a mean follow-up of 12.72 months. There were no major adverse events of deep vein thrombosis, blood vessel or nerve damage, hemarthrosis, arthralgia, or device-related adverse events. Two patients (5.4%) were readmitted because of pain, probably resulting from an inflammatory reaction to BST-CarGel. At 1 year postoperatively, there were statistically significant improvements in the iHOT (40.4 to 59.1; P < .001), HOS-ADL (60.6 to 71.4; P = .02), and HOS-SP (36.9 to 51.6; P = .01) scores. When the patients were subdivided based on the chondral defect size, the iHOT score improved for all chondral defect sizes, and the HOS-SP score improved in patients with medium (2-4 cm2) and very large (>6 cm2) chondral defects. In addition, the iHOT score improved whether the patients had their labrum repaired or reconstructed ( P < .001 and P = .02, respectively). Conclusion: The arthroscopic treatment of chondral acetabular defects with BST-CarGel demonstrates a satisfactory safety profile, with statistically significant improvement in patient-reported clinical outcome scores, even for those with very large chondral defect sizes.


2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Handan Akil ◽  
Vikas Chopra ◽  
Alex S. Huang ◽  
Ramya Swamy ◽  
Brian A. Francis

Purpose. To assess the safety and efficacy of Trabectome procedure in patients with preoperative intraocular pressure (IOP) of 30 mmHg or higher. Methods. All patients who had underwent Trabectome stand-alone or Trabectome combined with phacoemulsification were included. Survival analysis was performed by using Kaplan-Meier, and success was defined as IOP ≤ 21 mmHg, 20% or more IOP reduction from baseline for any two consecutive visits after 3 months, and no secondary glaucoma surgery. Results. A total of 49 cases were included with an average age of 66 (range: 13–91). 28 cases had Trabectome stand-alone and 21 cases had Trabectome combined with phacoemulsification. Mean IOP was reduced from a baseline of 35.6 ± 6.3 mmHg to 16.8 ± 3.8 mmHg at 12 months (p<0.01∗), while the number of medications was reduced from 3.1 ± 1.3 to 1.8 ± 1.4 (p<0.01∗). Survival rate at 12 months was 80%. 9 cases required secondary glaucoma surgery, and 1 case was reported with hypotony at day one, but resolved within one week. Conclusion. Trabectome seems to be safe and effective in patients with preoperative IOP of 30 mmHg or greater. Even in this cohort with high preoperative IOP, the end result is a mean IOP in the physiologic range.


Medicina ◽  
2021 ◽  
Vol 57 (12) ◽  
pp. 1370
Author(s):  
Sanghyuk Han ◽  
Robert Kim ◽  
Tae Seob Kim ◽  
Jung Heum Park ◽  
Seung Soo Kim ◽  
...  

Background and objectives We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods The current retrospective, observational study was conducted in a total of 2612 patients (n =2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January, 2017 and 31 August 2021. Results Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39–1712.32). Then, the Motiva Ergonomix™SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48–1837.56]), followed by the BellaGelÒSmoothFine (1458.4 ± 65.76 days [95% CI 1329.56–1587.28]), the SebbinÒ Sublimity (1322.00 ± 51.20 days [95% CI 1221.64–1422.32]), the BellaGelÒ Smooth (1138.72 ± 161.28 days [95% CI 822.6–1454.84), the MentorÒ MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28–801.52]) and the NatrelleÒ INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04–714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and MentorÒ MemoryGel™ Xtra showed no postoperative complications. However, the BellaGelÒSmoothFine, SebbinÒ Sublimity and BellaGelÒ Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center studywith long periods of follow-up.


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