Clinical Trial: Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Use of Intracameral Moxifloxacin for the Prevention of Acute Endophthalmitis Following Cataract Surgery: a Controlled and Randomized Clinical Trial
Brief Summary: There has thus far been only one randomized and masked clinical trial in the world to evaluate the efficacy of the intraoperative intracameral injection of antibiotics with the objective of preventing endophthalmitis following cataract surgery. The ESCRS study from 2007 confirmed that the intracameral use of cefuroxime reduced the incidence of endophthalmitis approximately fivefold. Unlike in Europe, where this drug came to be widely used after the 2007 results, cefuroxime is not commercially available in Brazil. Many studies around the world have substituted cefuroxime with moxifloxacin, which is a drug that is easily found around the world in eye drop form. It is widely used in postoperative regimens in cases of ophthalmologic surgeries, and it is free of preservatives that are toxic to intraocular structures (corneal endothelial cells). Three studies (all respective) found that the intracameral use of moxifloxacin is safe and effective for preventing endophthalmitis following cataract surgery; however, no controlled, randomized, and masked clinical trials have been performed with this objective. If this trial confirms its hypothesis (a reduction in the incidence of endophthalmitis following cataract surgery) and if minimal side effects are reported, moxifloxacin may be an option for routine intracameral use during cataract surgery, thus reducing cases of endophthalmitis and consequent cases of blindness.
Detailed Summary:
Patients who are diagnosed with cataracts and for whom surgery is indicated shall be evaluated in terms of their visual acuity and refractive error and via biomicroscopy, automated keratometry (Auto Kerato Refractometer KR 8000® Alcon), Goldmann applanation tonometry, fundoscopy, biometric assessment (Ocuscan RxP® Alcon or Lenstar LS900® Haag-Streit International), and specular microscopy of the cornea (EM-3000® Tomey) to count the corneal endothelial cells. Each cataract case shall be classified based on the Lens Opacities Classification System III (LOCS III).
Patients who choose to sign the informed consent form after being informed of all of the aspects of the surgery and this trial shall be randomly divided into 2 groups that shall be approximately equal in size and stratified by gender. Group A shall receive an intracameral injection of 0.03ml of 0.5% moxifloxacin (150 micrograms in 0.03 ml) at the end of the cataract surgery, followed by the use of a 0.5% moxifloxacin in eye drop form associated with 0.1% dexamethasone before the bandage is applied. Group B shall not receive the intracameral moxifloxacin injection at the end of the cataract surgery; these patients shall receive only 0.5% moxifloxacin in eye drop form associated with 0.1% dexamethasone before the bandage is applied.
The cataract surgery shall be performed using the standards followed by the Department of Ophthalmology at São Paulo State University, Campinas (UNICAMP). It shall be performed by second-, third-, and fourth-year ophthalmology residents and by attendings when cases are more complex. Preoperative pupil dilation shall be performed through the use of 10% phenylephrine and 1% tropicamide 3 times in five-minute increments. The anesthesiology technique used shall depend on each case and shall be either topical anesthesia
Sponsor: University of Campinas, Brazil
Current Primary Outcome: Endophthalmitis incidence [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Endothelial cell count [ Time Frame: 2 months ]
Original Secondary Outcome: Same as current
Information By: University of Campinas, Brazil
Dates:
Date Received: May 11, 2016
Date Started: January 2017
Date Completion: May 2018
Last Updated: March 15, 2017
Last Verified: March 2017
