Repeated exposure to antibiotics early in life, especially β-lactam agents, is associated with increased weight and height. If causality of obesity can be established in future studies, this further highlights the need for restrictive antibiotic use and avoidance of prescriptions when there is minimal clinical benefit.
To evaluate the long-term efficacy and safety of two minimally invasive glaucoma surgery implants with a subconjunctival drainage approach: the XEN45 Gel Stent â (Xen) implant and the PRESERFLO TM MicroShunt (MicroShunt). Methods: Retrospective comparative case series of primary open-angle glaucoma (POAG) patients with at least 6 months of follow-up after a MicroShunt or Xen implantation augmented with mitomycin C. Results: Forty-one eyes of 31 patients underwent Xen implantation, and 41 eyes of 33 patients, MicroShunt implantation. Baseline characteristics were similar, except for more combined surgeries with phacoemulsification in the Xen group (37% vs. 2%). Mean baseline IOP AE standard deviation dropped from 19.2 AE 4.4 to 13.8 AE 3.8 mmHg (n = 26) in the Xen group and from 20.1 AE 5.0 to 12.1 AE 3.5 (n = 14) in the MicroShunt group at 24 months of follow-up (p = 0.19, t-test). The number of IOP-lowering medications dropped from 2.5 AE 1.4 to 0.9 AE 1.2 in the Xen group and from 2.3 AE 1.5 to 0.7 AE 1.1 in the MicroShunt group. The probability of qualified success was 73% and 79% at 24 months of follow-up for the Xen and MicroShunt groups, respectively. Postoperative complications were usually mild and self-limiting. The number of bleb needling and secondary glaucoma surgery procedures was similar in both groups; however, in the Xen group more additional MicroPulse â transscleral cyclophotocoagulation procedures were performed. Conclusion: Xen Gel Stent and PreserFlo MicroShunt implantations achieved comparable results in POAG eyes in terms of IOP-lowering and surgical success, with a similar high safety profile.
Background Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. Trial registration ClinicalTrials.gov, Identifier: NCT03931564, Registered 30 April 2019.
Background In most cases, glaucoma patients require long-term medical and/or surgical treatment. Preference studies investigate how different aspects of glaucoma management, such as health or process outcomes, are valued and herewith help stakeholders make care more responsive to patients’ needs. As, to our knowledge, no overview of these studies is currently available, this study aims to systematically review and critically appraise these studies. Methods A systematic literature review was conducted using keywords for stated-preference studies and glaucoma up to October 2021. Studies were included if they were original research and used a stated-preference methodology to investigate preferences in patients or healthcare professionals for different aspects of glaucoma management. Data were extracted and summarized. Furthermore, a quality appraisal of the included studies was performed using two validated checklists. Results The search yielded 1214 articles after removal of duplicates. Of those, 11 studies fulfilled the inclusion criteria. Studies aimed to elicit preferences for glaucoma treatment (27%), glaucoma related health state valuation (36%), and services (36%) from the patient (91%) or ophthalmologists’ perspective (9%). Altogether studies included 69 attributes. The majority of attributes were outcome related (62%), followed by process (32%) and cost attributes (6%). Outcome attributes (e.g., effectiveness) were most often of highest importance to the population. Conclusions This systematic review provides an up-to-date and critical review of stated-preference studies in the field of glaucoma, suggesting that patients have preferences and are willing to trade-off between characteristics, and revealed that outcome attributes are the most influential characteristics of glaucoma management.
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