Active clinical trials for "Endophthalmitis"

Intravitreal injection (IVI) is an ophthalmological procedure used worldwide to treat ocular conditions. Its use has been steadily increasing for several years, because this method of drug delivery minimizes systemic exposure and allows for intraocular drug levels not achievable through systemic or topical drug administration. IVI of agents such as anti-vascular endothelial growth factor (anti-VEGF) or corticosteroids are efficacious for several retinal diseases, including age-related macular degeneration, macular edema due to retinal vein occlusion or diabetic macular edema, and uveitis, among others. But IVIs are not without their risk of complications and the most feared of which is infectious endophthalmitis, which can occur following intravitreal injections and has potentially devastating visual consequences, including loss of vision and/or the eye itself. Although endophthalmitis´s incidence ranges from 0-0.2% per infection, the cumulative risk for patients under sequential treatment may equate to more than 1% after 2 years of treatment. Endophthalmitis management following IVIs generally consists of a vitreous tap and inject (TAI) and/or a pars plana vitrectomy (PPV) with intravitreal injection of antibiotics. However, there is no consensus on the optimal treatment of IVI-related endophthalmitis. Thus, an established treatment protocol for IVI-related endophthalmitis is warranted to optimize patient outcomes. The aim of this study is to determine whether PPV or TAI is superior for the treatment of IVI-related endophthalmitis.

Open globe injuries (OGI) are among the main causes of blindness or irreversible severe reduction in visual acuity in the world. An estimated 2.3 million people live with bilateral low vision and nearly 19 million live with blindness or unilateral low vision due to such trauma. Pre-surgical prophylaxis to prevent serious infectious complications such as endophthalmitis is frequently performed, however, there are discrepancies in its performance between services as there is no proven superior protocol. Different combinations of antibiotics and administration routes are currently used. The aim of this study is to evaluate the efficacy and safety of the use of topical moxifloxacin 0.5% ophthalmic solution (Vigamox®) in the prophylaxis of acute endophthalmitis in patients with OGI. This is a prospective, controlled, randomized, single-center study conducted in patients diagnosed with OGI at the Clinical Hospital of São Paulo State University, Campinas. Volunteers who present OGI and sign the informed consent form (ICF) will be randomized into 2 groups: in group A, volunteers will undergo pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery. In group B, the volunteers will receive pre-surgical prophylaxis as it is currently done in the service, with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, prior to surgery. Intraoperative and post-surgical care will be the same for both groups and will continue to be carried out in line with the current service protocol. Patients will be followed for 45 days, with a complete ophthalmological evaluation that aims to verify the incidence of endophthalmitis in both groups. It is expected to find an equal or lower incidence of endophthalmitis in the group that received topical administration of moxifloxacin.

Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment. There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable. The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;

Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Despite the eye isolation from the rest of the body, germs can enter the eye either exogenously, during open globe surgery, following perforating eye trauma, or following anti-VEGF antibodies intravitreal injection, or other drugs such as corticosteroids for example, or by endogenous route, haematogenic as part of sepsis, usually during immunodepression. Post-operative endophthalmitis is the most feared complication following any endo-ocular surgery. It can be acute, occurring within 6 weeks post-operatively or delayed as after poor healing, or on a glaucoma filtration bubble. Endophthalmitis after cataract surgery is a complication with a low incidence of (0.030 to 0.047%) but which, due to interventions number carried out (830,000 in 2016, in France), appears significant. There are factors that favour endophtalmitis occurrence such as a vitreous exit from eyeball during surgical procedure, poor scar coaptation, premature removal of sutures, etc... They condition emergency care. Early diagnosis and appropriate treatment are essential for safeguarding the eye and its function. Therefore, therapeutic management requires endo-ocular sampling in front of any suspicion of endophtalmitis, to be done before any treatment, to carry out microbiological analysis (direct examination on slide, culture, universal and/or targeted PCR, antibiotic susceptibility test). Vitreous puncture is more contributive than anterior chamber puncture, underlining need for these two samples to identify the responsible germ. Once samples have been taken, a broad-spectrum antibiotic therapy introduction must be performed intra-vitreously combined with systemic and local administration. Intravitreal injections allow treatment to be provided at effective concentrations directly at the infection site. On the other hand, toxic risks must be taken into account, especially since the protocol may require multiple intravitreal injections.

This randomised clinical trial will explore the feasibility and acceptability of carrying out early vitrectomy surgical treatment compared to standard treatment in acute endophthalmitis. We will investigate the effectiveness of early vitrectomy plus intravitreal antibiotics compared to standard care intravitreal antibiotic injections in the management of postoperative exogenous endophthalmitis. This is a feasibility trial that will evaluate the expected effect size with which to inform the design of a definitive randomized trial of this question.

Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy

The goal of this study is to determine the safety (but not efficacy in preventing infection) of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin at certain dosages and concentrations as prepared by a compounding pharmacy when used intracamerally at the time of cataract surgery.

In this pilot study, the feasibility of the Oxford Nanopore MinION to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. The MinION is a low cost commercially available device for DNA/ RNA analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.

Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

To determine the role of initial pars plana vitrectomy in the management of postoperative bacterial endophthalmitis. To determine the role of intravenous antibiotics in the management of bacterial endophthalmitis. To determine which factors, other than treatment, predict outcome in postoperative bacterial endophthalmitis.