NCT02770729.
Trial name or title | Use of Intracameral Moxifloxacin for the Prevention of Acute Endophthalmitis Following Cataract Surgery: a Controlled and Randomized Clinical Trial |
Methods |
Study design: parallel group, randomized controlled trial Study follow‐up: 8 weeks |
Participants |
Setting: University of Campinas, Brazil Estimated enrolment: 6000 eyes of 6000 participants undergoing cataract surgery Inclusion criteria: people aged 50 to 100 years scheduled to undergo cataract surgery Exclusion criteria: vulnerable people; people with allergy to moxifloxacin; people with ocular or periocular infection, advanced glaucoma, or severe dry eye, or undergoing cataract surgery for traumatic cataract with ocular perforation or other reasons (e.g. glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery |
Interventions |
Intervention 1: intracameral injection of moxifloxacin 0.5% at conclusion of cataract surgery Intervention 2: no intracameral injection |
Outcomes | Primary outcome: risk of postoperative endophthalmitis at 1 month Secondary outcome: endothelial cell count at 2 months |
Starting date | Study dates: May 2016 to May 2018 |
Contact information | Principal investigator: Mathias V Mélega, MD University of Campinas, Brazil |
Notes | Study sponsor: University of Campinas, Brazil |