Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis.
Status:
Terminated
Trial end date:
2018-05-07
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Campinas, Brazil
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination