Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis.

• Status: Terminated
• Trial end date: 2018-05-07
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Campinas, Brazil
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

Diagnosis of visually significant cataract

Exclusion Criteria

• Moxifloxacin allergy

• Traumatic cataract with ocular perforation

• Cataract surgery associated with other procedures, such as glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery

• Signs of ocular or periocular infection

• Advanced glaucoma

• Severe dry eye